HANDBOOK OF - Lambda...HANDBOOK OF BIOANALYTICAL METHODSat LAMBDA THERAPEUTIC RESEARCH Edition:...

Edition: January 2015

HANDBOOK O FB I O A N A L Y T I C A L M E T H O D S at

LAMBDA THERAPEUTIC RESEARCH

Edition: August 2019

Bio-analytical Lambda is one of the most experienced Bioanalytical service providers in India. We provide

these services from two different strategic locations - India and Canada. Our highly qualified

and experienced scientists work 24x7 and have an accumulated global catalogue of more

than 1200 validated methods. Our vast expertise and in-depth understanding of the stringent

regulatory demands ensures each project is accomplished in rapid turn-around times.

qualified (Ph. D, M. Pharm, M.Sc, B.Pharm) and experience team comprising of 150+

research professionals

GLP certified Bioanalytical labs in India and Canada

Capabilities of analyzing 90,000+ samples per month on 50+ LC-MS/MS

7-8 new methods in development/month with expertise in handling different matrices

such as plasma, serum, urine, whole blood, milk, food, bone, stool and animal tissues

Infrastructure

Separate well equipped extraction labs and chromatography labs.

Separate lab for photosensitive drug. Separate room for storage of standards /

balance room.

Low temperature storage (-22 ± 5 °C, -65 ± 10 °C)

Biolyte (Chromatographic Data review and data printing software)

Different types of 50+ LC-MS/MS systems (including API 6500 and Waters Xevo TQ-S)

Regulatory Track Record

Table of Contents

Title Page

Large Molecules / Therapeutic Proteins / Biosimilars ............... 1

Small Molecules ............... 2

New Chemical Entities ............... 68

In‐Vitro Studies ............... 69

Immunogenicity Assesment ............... 70

PD Markers ............... 71

Evaluation Of Effectiveness Of Healthcare Hygiene Products ............... 73

Sr. No. Drug NameInstrument/Method of

AnalysisMatrix Range Anticoagulant Dose

1 Bevacizumab Sandwich ELISAHumanSerum

150 to 6000 ng / mL NA NA

2 *Bevacizumab LC-MS/MS (6500 QTRAP)HumanSerum

5 to 500 µg / mL NA NA

3 Darbepoetin Sandwich ELISAHumanSerum

0.075 to 2.6 ng / mL NA 0.45µg/kg

4 Denosumab Sandwich ELISAHumanSerum

160 to 10000 ng / mL NA 60 mg

5 Erythropoietin Sandwich ELISAHumanSerum

5.005 to 200 mIU / mL NA 50IU/kg

6 Etanercept Sandwich ELISAHumanSerum

39.063 to 5000 ng / mL NA 50mg

7 Glucagon LC-MS/MS (Waters XEVO TQ-S)Human Plasma

0.2 to 10 ng / mL K2EDTA 1 mg/vial

8 Rituximab Competitive ELISAHuman Plasma

50 to 1502 ng / mL K2EDTA 100mg/10mL

9 rHu-FSHElectrochemiluminescence Immunoassay

HumanSerum

0.156 to 20 mIU/mLNA 300 IU

10 *Teriparatide LC-MS/MS (6500 QTRAP) HumanSerum

5 to 500 pg / mL NA NA

11 Teriparatide Sandwich ELISAHumanSerum 10 to 400 pg / mL NA NA

12 Trastuzumab LC-MS/MS (6500 QTRAP)HumanSerum

5 to 500 µg / mL NA 8 mg / Kg

13 *Trastuzumab Competitive ELISAHumanSerum

9.7 to 625 ng / mL NA NA

14 PEG G-CSF Sandwich ELISAHumanSerum

0.150 to 10 ng / mL NA 6mg /0.6 mL SC

15 *Romiplostim Sandwich ELISAHumanSerum

0.040 to 5.000 ng/mL NA 250 µg/0.5 mL

Lambda Therapeutic Research

LARGE MOLECULES / THERAPEUTIC PROTEINS / BIOSIMILARS

Location : India

*: Developed method available

Page 1 of 73

Drug Name Instrument Matrix Range Anticoagulant DoseNew /

Modified Method

1 AcetaminophenLC-MS/MS

(API 300 or 3000)Human Plasma

0.1 to 13 µg / mL K2EDTA -

2 AcetaminophenLC-MS/MS

(Waters QPXE)Human Plasma

0.1 to 13 µg / mL K2EDTA 320 mg

3 Acyclovir HPLC-UVHuman Plasma

5 to 1280 ng / mL Heparin -

4 AcyclovirHPLC

- FlurosenceHuman Plasma

10 to 2560 ng / mLSodium heparin

-

5 AcyclovirHPLC



6 AcyclovirLC-MS/MS (Thermo)

Human Plasma

5 to 1600 ng / mL K2EDTA 200 mg

7 AlverineLC-MS/MS (Thermo)

Human Plasma

0.05 to 10 ng / mL K2EDTA 120 mg

8 AllopurinolLC-MS/MS (Thermo)

Human Plasma

10 to 5000 ng/mL K2EDTA 200 mg

9 AmantadineLC-MS/MS


2 to 1500 ng / mL K2EDTA 300mg

10 AmantadineLC-MS/MS (Thermo)

Human Urine

20 to 3000 ng / mL Not

applicable160 mg

AmitriptylineLC-MS/MS(API 3000)

Human Plasma

0.4 to 51 ng / mL K2EDTA -

NortriptylineLC-MS/MS(API 3000)

Human Plasma


12 AmlodipineLC-MS/MS(API 3000)

Human Plasma


13 Amphotericin BLC-MS/MS


5 to 5000 ng / mL K2EDTA 200 to 400 mg

14 AlectinibLC-MS/MS (Thermo)

Human Plasma

1 to 600 ng/mL K2EDTA 50mg

15 AlectinibLC-MS/MS (Thermo)

Human Plasma


16 AlendronateLC-MS/MS(API 3000)

Human Urine

1 to 256 ng / mLNot

applicable-

17 AnastrozoleLC-MS/MS(API 3000)

Human Plasma


18 AtomoxetineLC-MS/MS (Thermo)

Human Plasma

0.500 to 500 ng/mL K2EDTA 10 mg

19 AtomoxetineLC-MS/MS (Thermo)

Human Plasma


AtomoxetineLC-MS/MS (Thermo)

Human Plasma


4-HydroxyatomoxetineLC-MS/MS (Thermo)

Human Plasma

2 to 512 ng / mL K2EDTA -

N-DesmethylatomoxetineLC-MS/MS (Thermo)

Human Plasma


21 AtorvastatinLC-MS/MS (Thermo)

Human Plasma

0.3 to 300 ng/mLSodium heparin

80 mg

AtorvastatinLC-MS/MS (Thermo)

Human Plasma


o-hydroxyatorvastatinLC-MS/MS (Thermo)

Human Plasma

0.4 to 102.5 ng / mL K2EDTA -

p-hydroxyatorvastatinLC-MS/MS (Thermo)

Human Plasma


Lambda Therapeutic ResearchSMALL MOLECULES

Sr. No.

A

11

20

22

C A

N A

D A

Location : Canada

Page 2 of 73


Modified Method


Sr. No.


Dog Plasma

0.25 to 2500 ng / mL K2EDTA 5 mg to 80 mg


Dog Plasma

0.25 to 500 ng / mL K2EDTA -


Dog Plasma

0.25 to 500 ng / mL K2EDTA -

Atorvastatin LactoneLC-MS/MS (Thermo)

Dog Plasma

0.5 to 2500 ng / mL K2EDTA -

o-Hydroxy Atorvastatin Lactone

LC-MS/MS (Thermo)

Dog Plasma


p-Hydroxy Atorvastatin Lactone

LC-MS/MS (Thermo)

Dog Plasma



Dog Plasma

10 to 2500 ng / mL K2EDTA 5 mg to 80 mg


Dog Plasma



Dog Plasma


Atorvastatin LactoneLC-MS/MS (Thermo)

Dog Plasma


o-Hydroxy Atorvastatin Lactone

LC-MS/MS (Thermo)

Dog Plasma


p-Hydroxy Atorvastatin Lactone

LC-MS/MS (Thermo)

Dog Plasma



Human Plasma

10 to 15000 pg / mL K2EDTA 10 mg

o-Hydroxy Atorvastatin LC-MS/MS (Thermo)

Human Plasma

10 to 10000 pg / mL K2EDTA -

p-Hydroxy Atorvastatin LC-MS/MS (Thermo)

Human Plasma

10 to 5000 pg / mL K2EDTA -


Human Plasma


o-Hydroxy Atorvastatin LC-MS/MS (Thermo)

Human Plasma


p-Hydroxy Atorvastatin LC-MS/MS (Thermo)

Human Plasma


GlimepirideLC-MS/MS (Thermo)

Human Plasma


27 AtazanavirLC-MS/MS (Thermo)

Human Plasma


28 AxitinibLC-MS/MS (Thermo)

Human Plasma


29 AzithromycinLC-MS

(API 150)Human Plasma


600 mg

30 AbacavirLC-MS/MS



AbacavirLC-MS/MS


25 to 12000 ng / mL K2EDTA 600 mg

Lamivudine LC-MS/MS



Abacavir LC-MS/MS



Lamivudine LC-MS/MS


20 to 5000 ng / mL K2EDTA 150mg32

23

24

C A

N A

D A

25

26

Location : India

31

I N D

I A

Page 3 of 73


Modified Method


Sr. No.

Abacavir LC-MS/MS

(Shimadzu 8045)Human Plasma 25 to 6000 ng/mL K2EDTA 300mg

Lamivudine LC-MS/MS

(Shimadzu 8045)Human Plasma


34 AbirateroneLC-MS/MS (Thermo)

Human Plasma


35 AcamprosateLC-MS/MS (Thermo)

Human Plasma

0.5 to 400 ng / mL K2EDTA 2 X 333 mg i.e. 666mg dose

36 AcetazolamideLC-MS/MS (API 3200)

Human Plasma

0.1 to 40 μg/mL K2EDTA 500 mg

37 AceclofenacLC-MS/MS (API 2000)

Human Plasma


100 mg

Acetyl salicylic acid HPLC-UVHuman Plasma

0.05 to 8 µg / mL K2EDTA / Heparin

650 mg

Salicylic acid HPLC-UVHuman Plasma

0.4 to 40 µg / mLK2EDTA / Heparin

-

Acetyl salicylic acid LC-MS/MS (API 4000)

Human Plasma

2.5 to 500 ng/ mL K2EDTA 25 mg

Salicylic acidLC-MS/MS (API 4000)

Human Plasma

100 to 6000 ng / mL K2EDTA -

40 Acetyl salicylic acidLC-MS/MS (API 4000)

Human Plasma


Acetyl salicylic acid LC-MS/MS (API 4000)

Human Plasma

2.5 to 1500 ng / mL K2EDTA 100 mg

Salicylic acidLC-MS/MS (API 4000)

Human Plasma

150 to 10000 ng / mL K2EDTA -

AcitretinLC-MS/MS(Shimadzu

8060)

Human Plasma


13-Cis - Acitretinin LC-MS/MS(Shimadzu

8060)

Human Plasma


43 AcrivastineLC-MS/MS (API 4000)

Human Plasma


AlbendazoleLC-MS/MS


0.3 to 150 ng / mL K2EDTA 400mg

Albendazole Sulfoxide

LC-MS/MS(Waters QPXE)

Human Plasma

5 to 2500 ng / mL K2EDTA NA

45 Albuterol LC-MS/MS

(Waters QPXE)HumanPlasma


46 AlectinibLC-MS/MS (API 4000)

Human Plasma


47 *AlendronateLC-MS/MS (API 4000)

Human Urine

2 to 600 ng / mL NA 70 mg

48 *AlendronateLC-MS/MS (API 4000)

Human Plasma


49 *AlendronateLC-MS/MS (Thermo)

Human Plasma


50 AllopurinolLC-MS/MS (API 3200)

Human Plasma


AllopurinolLC-MS/MS



Oxypurinol LC-MS/MS


50 to 10000 ng / mL K2EDTA -

33

44

51

38

39

41

I N D

I A

42

Page 4 of 73


Modified Method


Sr. No.

52 AlogliptinLC-MS/MS (API 3200)

Human Plasma


53 AlogliptinLC-MS/MS (API 4000)

Human Plasma

0.5 to 150 ng / mL K2EDTA 12.5 mg

54 AlverineLC-MS/MS (API 4000)

Human Plasma

20 to 7500 pg/mL K2EDTA 120 mg

55 AmantadineLC-MS/MS (Thermo)

Human Plasma


56 AmbrisentanLC-MS/MS (Thermo)

Human Plasma


57 AmlodipineLC-MS/MS (API 4000)

Human Plasma

0.2 to 10 ng / mLSodium heparin

5 mg / 10 mg

*Amlodipine (R )LC-MS/MS (API 4000)

Human Plasma

0.1 to 5 ng / mL K2EDTA 5 mg / 10 mg

*Amlodipine (S)LC-MS/MS (API 4000)

Human Plasma

0.1 to 7.5 ng / mL K2EDTA 5 mg / 10 mg


Human Plasma


5 mg / 10 mg


HumanPlasma

0.1 to 7.5 ng / mLSodium heparin

5 mg / 10 mg


HumanPlasma



HumanPlasma


AmlodipineLC-MS/MS (API 4000)

Human Plasma


OlmesartanLC-MS/MS (API 4000)

Human Plasma


AmlodipineLC-MS/MS (API 4000)

Human Plasma


ValsartanLC-MS/MS (API 4000)

Human Plasma


Amlodipine LC-MS/MS (API 4000)

Human Plasma


ValsartanLC-MS/MS (API 4000)

Human Plasma

50 to 20000 ng / mL K2EDTA 320 mg

AmlodipineLC-MS/MS



Telmisartan LC-MS/MS



65 AmilorideLC-MS/MS



66 AmiodaroneLC-MS/MS



AmiodaroneLC-MS/MS



N-Desethyl Amiodarone

LC-MS/MS (Waters QPXE)

Human Plasma

2 to 100ng / mL K2EDTA -

Amitriptyline LC-MS/MS



Nortriptyline LC-MS/MS



Amitriptyline LC-MS/MS



Nortriptyline LC-MS/MS


0.2 to 18 ng/mL K2EDTA -

70 AmitriptilineLC-MS/MS


0.3 to 90 ng/mL K2EDTA 25mg

58

59

61

69

60

64

I N D

I A

68

62

63

67

Page 5 of 73


Modified Method


Sr. No.

71 AmitriptilineLC-MS/MS



AmodiaquineLC-MS/MS



N-desethyl Amodiaquine


Human Plasma


73 AmoxicillinLC-MS/MS


0.1 to 35 µg / mL K2EDTA 1 gm

74 Amoxicillin HPLC-UVHuman Plasma


500 mg





(Waters XEVO TQ-S)Human Plasma


500 mg

AmoxicillinLC-MS/MS (API 4000)

Human Plasma

100 to 15000 ng / mL

Sodium heparin

400 mg

Clavulanic acid LC-MS/MS (API 4000)

Human Plasma


57 mg

AmoxyxillinLC-MS/MS


75 to 35000 ng / mLSodium Heparin

600 mg

Clavulanic acidLC-MS/MS


10 to 3450 ng / mL Sodium Heparin

42.9 mg

79 Amphotericin B HPLC-UVHumanPlasma


80 Amphotericin-BLC-MS/MS (API 4000)

Human Plasma

5 to 5000 ng / mL K2EDTA 0.6 mg/kg to 1.5 mg/kg

81 Amphotericin BLC-MS/MS

(Waters XEVO TQ-S)HumanPlasma

100 to 2000 pg / mL K2EDTA NA

82 Amphotericin-B (Total)LC-MS/MS (Thermo)

Human Plasma

0.5 to 100 µg / mL K2EDTA 20 mg/kg

83*Amphotericin B (free) (Liposomal)

LC-MS/MS (API 4000)

Human Plasma

10 to 3000 ng / mL K2EDTA 50mg/vial

84 *Amphotericin B (free) LC-MS/MS


10 to 3000 ng/mL K2EDTA 3mg/KG

85*Amphotericin B Encapsulated & Total

LC-MS/MS(Shimadzu 8045)

Human Plasma

0.25 to 75 µg/mL K2EDTA 2mg/kg(50mg Injection)

86 AnastrozoleLC-MS/MS (API 3200)

Human Plasma


1 mg

87 *Anagrelide LC-MS/MS(Thermo)

Human Plasma

0.05 to 10 ng / mL K3EDTA 0.5 mg

88 ApixabanLC-MS/MS (Thermo)

Human Plasma


89Apovincaminic acid


Human Plasma

0.25 to 50 ng / mL K2EDTA 5 mg of Vinpocetine

90 Apovincaminic acid LC-MS/MS


0.5 to 180 ng / mL K2EDTA 15 mg of Vinpocetine

91 ApremilastLC-MS/MS (API 4000)

Human Plasma


Aripiprazole LC-MS/MS



Dehydro aripiprazole LC-MS/MS



93 Aripiprazole LC-MS/MS



94 Aripiprazole LC-MS/MS



ArtemetherLC-MS/MS (API 4000)

HumanPlasma


DihydroartemisininLC-MS/MS (API 4000)

HumanPlasma

2 to 250ng / mL K2EDTA 80 mg

96 AtazanavirLC-MS/MS(Thermo)

HumanPlasma


I N D

I A

72

77

78

92

95

Page 6 of 73


Modified Method


Sr. No.

97 AtazanavirLC-MS/MS



98 AtazanavirLC-MS/MS (API 4000)

HumanPlasma


99 Atenolol HPLC - FlurosenceHuman Plasma

10 to 800 ng / mLK2EDTA / Heparin

100 mg

AtenololLC-MS/MS



Nifedipine LC-MS/MS



AtorvastatinLC-MS/MS(Thermo)

Human Plasma


O-Hydroxy AtorvastatinLC-MS/MS(Thermo)

Human Plasma


P-Hydroxy AtorvastatinLC-MS/MS(Thermo)

Human Plasma


AtorvastatinLC-MS/MS (API 4000)

HumanPlasma


O-Hydroxy AtorvastatinLC-MS/MS (API 4000)

HumanPlasma

0.25 to 150 ng / mL K2EDTA -

P-Hydroxy AtorvastatinLC-MS/MS (API 4000)

HumanPlasma


AtorvastatinLC-MS/MS (API 4000)

HumanPlasma


O-Hydroxy Atorvastatin LC-MS/MS (API 4000)

HumanPlasma


P-Hydroxy AtorvastatinLC-MS/MS (API 4000)

HumanPlasma


104 AtorvastatinLC-MS/MS (API 3200)

Human Plasma


105 AtorvastatinLC-MS/MS(Thermo)

HumanPlasma



HumanPlasma



HumanPlasma

0.1 to 150 ng/mL K2EDTA 80 Mg

108 Atovaquone LC-MS/MS



109 Atovaquone LC-MS/MS (API 3200)

HumanPlasma

30 to 7500 ng/mL K2EDTA 750 mg / 5 mL

110 Atovaquone LC-MS/MS (API 4000)

HumanPlasma

100 to 20000 ng/mL K2EDTA 750 mg / 5 mL fed

111 *5-Azacytidine LC-MS/MS



100 mg

112 AzathioprineLC-MS/MS (Thermo)

HumanPlasma


*AzelastineLC-MS/MS(Thermo)

Human Plasma

5 to 1000 pg / mL K2EDTA 0.56 mg

*N-desmethyl Azelastine

LC-MS/MS(Thermo)

Human Plasma


114 AzithromycinLC-MS/MS (API 3200)

Human Plasma


115 AzithromycinLC-MS/MS


1 to 500 ng/mL K2EDTA 200mg/5mL Yes

116 AzithromycinLC-MS/MS(Shimadzu

8045)

HumanPlasma

5 to 1010 ng/mL K2EDTA 200mg/5 mL

117 AzithromycinLC-MS/MS (API 3200)

Human Plasma


I N D

I A

100

101

103

102

113

Page 7 of 73


Modified Method


Sr. No.

118 BarnidipineLC-MS/MS (Thermo)

Human Plasma


119 BarnidipineLC-MS/MS (Thermo)

Human Plasma

15 to 7000 pg/mL K2EDTA 20mg

120 R-BaclofenLC-MS/MS(Thermo)

Human Plasma


R-BaclofenLC-MS/MS(Thermo)

Human Plasma


S-BaclofenLC-MS/MS(Thermo)

Human Plasma


R-BaclofenLC-MS/MS(Thermo)

Human Urine

2 to 2000 ng / mLNot

applicable20 mg

S-BaclofenLC-MS/MS(Thermo)

Human Urine


applicable20 mg

BetamethasoneLC-MS/MS(Thermo)

Human Plasma


Betamethasone Acetate

LC-MS/MS(Thermo)

Human Plasma


BetamethasonePhosphate

LC-MS/MS(Thermo)

Human Plasma


124 BudesonideLC-MS/MS (API 6500)

Human Plasma

20 to 10000 pg/mLSodium heparin

3 x 3 mg

BupropionLC-MS/MS(API 3000)

Human or Rat Plasma


348 mg

Bupropion ErythroaminoAlcohol

LC-MS/MS(API 3000)

Human or Rat Plasma


-

Bupropion ThreoaminoAlcohol

LC-MS/MS(API 3000)

Human or Rat Plasma


-

HydroxybupropionLC-MS/MS(API 3000)

Human or Rat Plasma


-


Human Plasma


174 mg

Bupropion Erythroamino Alcohol

LC-MS/MS(API 3000)

Human Plasma


-

Bupropion Threoamino Alcohol

LC-MS/MS(API 3000)

Human Plasma


-


Human Plasma


-

B

121

122

123

C A

N A

D A

Location : Canada

125

126

Page 8 of 73


Modified Method


Sr. No.


Human Urine


applicable174 mg


LC-MS/MS(API 3000)

Human Urine


applicable-


LC-MS/MS(API 3000)

Human Urine


applicable-


Human Urine

62.5 to 4000 ng / mLNot

applicable-

BupropionLC-MS/MS(Thermo)

Rat Plasma


-


LC-MS/MS(Thermo)

Rat Plasma


-


LC-MS/MS(Thermo)

Rat Plasma


-

HydroxybupropionLC-MS/MS(Thermo)

Rat Plasma


-

BuprenorphineLC-MS/MS(API 3000)

HumanPlasmaor DogPlasma


-

NorbuprenorphineLC-MS/MS(API 3000)

HumanPlasmaor Dog Plasma


-

BuprenorphineLC-MS/MS (API 6500)

Human Plasma

25 to 10000 pg / mLSodium heparin

8 mg

NorbuprenorphineLC-MS/MS (API 6500)

Human Plasma


-

BuspironeLC-MS/MS(API 300 or 3000)

Human Plasma


-

1-(2-Pyrimidyl)PiperazineLC-MS/MS(API 300 or 3000)

Human Plasma


-

BuspironeLC-MS/MS(API 3000)

Human Plasma

or MousePlasma


1-(2-Pyrimidyl)PiperazineLC-MS/MS(API 3000)

Human Plasma

or MousePlasma

1.6 to 307.2 ng / mL K3EDTA -


HumanPlasma

or MousePlasmaor RatPlasmaor DogPlasma


-


HumanPlasma

or MousePlasmaor RatPlasmaor DogPlasma


-

132

C A

N A

D A

133

127

128

129

130

131

Page 9 of 73


Modified Method


Sr. No.

Buspirone LC-MS/MS(API 300 or 3000)

Human Plasmaor RatPlasmaor DogPlasma

0.4 to 50 ng / mL Heparin -

1-(2-Pyrimidyl) PiperazineLC-MS/MS(API 300 or 3000)

Human Plasmaor RatPlasmaor DogPlasma



Human Plasma


-


Human Plasma


-

6-HydroxybuspironeLC-MS/MS(API 3000)

Human Plasma


-

136 *Baclofen(R & S)LC-MS/MS(Shimadzu

8045)

Human Plasma


Benazepril LC-MS/MS



Benazeprilat LC-MS/MS



BenazeprilLC-MS/MS



BenazeprilatLC-MS/MS



139 BendroflumethiazideLC-MS/MS



BendroflumethiazideLC-MS/MS (Thermo)

Human Plasma

0.1 to 70 ng/mL K2EDTA 2.5 mg

Bendroflumethiazide impurity

LC-MS/MS (Thermo)

Human Plasma 0.1 to 15 ng/mL K2EDTA 2.5 mg

Benzbromarone LC-MS/MS

(Waters QPXE)Human Plasma 10 to 5000 ng/mL K2EDTA 50mg

6-Hydroxy benzbromarone LC-MS/MS



142 BenzhexolLC-MS/MS



143 *BetahistineLC-MS/MS (API 6500)

Human Plasma

7.5 to 2000 pg/mL K2EDTA 24 and 48 mg

144 BexaroteneLC-MS/MS (API 3200)

Human Plasma


145 Bezafibrate LC-MS/MS (API 4000)

Human Plasma

80 to 22000 ng/mL K2EDTA 200mg/400mg

I N D

I A

134

135

Location : India

140

C A

N A

D A

141

137

138

Page 10 of 73


Modified Method


Sr. No.

146 Bezafibrate LC-MS/MS (API 4000)

Human Plasma


147 BicalutamideLC-MS/MS (API 2000)

Human Plasma

10 to to 1000 ng / mL

Heparin 25 mg


Human Plasma

25 to 4500 ng/mL K2EDTA 150mg Yes


Human Plasma

50 to 2000 ng / mL K2EDTA / Heparin 50 mg


Human Plasma

100 to 5000 ng / mL

K2EDTA 150 mg

151 *Bicalutamide (R & S)LC-MS/MS



*R- BicalutamideLC-MS/MS (API 3200)

Human Plasma


*S- BicalutamideLC-MS/MS (API 3200)

Human Plasma

4 to 1000 ng/mL K2EDTA NA

153 Bictegravir LC-MS/MS


30 to 12000 ng/mL K2EDTA 50mg Fast/Fed

154 BilastineLC-MS/MS (API 4000)

Human Plasma


155 BisoprololLC-MS/MS (API 3200)

Human Plasma


156 BosentanLC-MS/MS (API 3200)

Human Plasma


157 *BortezomibLC-MS/MS(Thermo)

Rat Plasma


62.5 µg/kg to 250 µg/kg

(Subcutaneous)

158 *BortezomibLC-MS/MS

(Waters QPXE)Rat

Plasma2 to 8000 ng / mL

Sodium heparin

62.5 µg/kg to 250 µg/kg (IV)

159 BrexpiprazoleLC-MS/MS (Thermo)

Human Plasma


160 *BudesonideLC-MS/MS



161 *BudesonideLC-MS/MS(Thermo)

Human Plasma


3 X 3 mg


(WatersXEVO TQ-S)

Human Plasma


3X3 mg

163 *BudesonideLC-MS/MS(Shimadzu

8060)

Human Plasma




5 to 5000 pg/mL K2EDTA 1mg/2mL inhalation

Yes

165 BuspironeLC-MS/MS


20 to 30000 pg / mL

K2EDTA 15 mg

166 BupropionLC-MS/MS (API 4000)

Human Plasma


167 BupropionLC-MS/MS


1 to 400 ng / mL K2EDTA 300 mg/150mg

I N D

I A

152

Page 11 of 73


Modified Method


Sr. No.

Bupropion LC-MS/MS



HydroxybupropionLC-MS/MS



*BupropionLC-MS/MS



*Hydroxy BupropionLC-MS/MS



*Erythro hydro BupropionLC-MS/MS



* Threo hydro BupropionLC-MS/MS



BupropionLC-MS/MS (API 6500)

Human Plasma


Hydroxy BupropionLC-MS/MS (API 6500)

Human Plasma

2 to 1500 ng/mL, K2EDTA -

Erythro Hydro BupropionLC-MS/MS (API 6500)

Human Plasma


Threo Hydro BupropionLC-MS/MS (API 6500)

Human Plasma


*BupropionLC-MS/MS(Thermo)

Human Plasma


*Hydroxy BupropionLC-MS/MS(Thermo)

Human Plasma


*Erythro hydro BupropionLC-MS/MS(Thermo)

Human Plasma


* Threo hydro BupropionLC-MS/MS(Thermo)

Human Plasma

1.5 to 1000 ng / mL K2EDTA -

Carbamazepine HPLC-UVHuman Plasma


400 mg

Carbamazepine-10,11-epoxide

HPLC-UVHuman Plasma


-

CarvedilolLC-MS/MS(Thermo)

Human Plasma


O-DesmethylcarvedilolLC-MS/MS(Thermo)

Human Plasma


4'-Hydroxyphenyl carvedilolLC-MS/MS(Thermo)

Human Plasma


5'-Hydroxyphenyl carvedilolLC-MS/MS(Thermo)

Human Plasma


174 Cefaclor HPLC-UVHuman Plasma

0.2 to 25 µg / mLLithium heparin

500 mg

175 Cefixime HPLC-UVHuman Plasma

0.1 to 13 µg / mLSodium heparin

400 mg

176 Cefuroxime HPLC-UVHuman Plasma


177 CefuroximeLC-MS/MS(Thermo)

Human Plasma

100 to 20135 ng / mL K2EDTA 500 mg

CAN

ADA

170

171

CLocation : Canada

172

173

168

169

I N D

I A

Page 12 of 73


Modified Method


Sr. No.

178 CelecoxibHPLC



200 mg

179 CelecoxibLC-MS/MS(API 3000)

Human Plasma


180 Cephalexin HPLC-UVHuman Plasma


181 CetirizineLC-MS/MS(API 3000)

Human Plasma


CetirizineLC-MS/MS



PseudoephedrineLC-MS/MS



183 ChlorpheniramineLC-MS/MS(API 3000)

Human Plasma

0.1 to 51 ng / mL K2EDTA 8 mg / 5 mL

184 ChlorthalidoneLC-MS/MS (Thermo)

Human Plasma


185 ChlorzoxazoneLC-MS/MS (Thermo)

Human Plasma

0.1 to 50 µg/mL K2EDTA 750mg

CilazaprilLC-MS/MS(API 3000)

Human Plasma


Cilazaprilat LC-MS/MS(API 3000)

Human Plasma


CilazaprilLC-MS/MS(API 3000)

Human Plasma

4 to 1024 ng / mL K3EDTA 2.5 mg

Cilazaprilat LC-MS/MS(API 3000)

Human Plasma

1 to 256 ng / mL K3EDTA 2.5 mg

188 CiprofloxacinHPLC






Ciprofloxacin HPLC-UVHuman Urine

1.5 to 15 µg / mLNot

applicable-

Desethyleneciprofloxacin HPLC-UVHuman Urine


applicable-

Sulfociprofloxacin HPLC-UVHuman Urine


applicable-

Oxociprofloxacin HPLC-UVHuman Urine


applicable-

Formylciprofloxacin HPLC-UVHuman Urine


applicable-

191 CitalopramHPLC



192 CitalopramHPLC



-

CitalopramLC-MS/MS(API 3000)

Human Plasma


20 mg

DemethylcitalopramLC-MS/MS(API 3000)

Human Plasma


-

DidemethylcitalopramLC-MS/MS(API 3000)

Human Plasma


-

CitalopramLC-MS/MS(API 3000)

Human Plasma


40 mg

DemethylcitalopramLC-MS/MS(API 3000)

Human Plasma


-

DidemethylcitalopramLC-MS/MS(API 3000)

Human Plasma


-

S-CitalopramLC-MS/MS(API 3000)

Human Plasma


40 mg

S-DemethylcitalopramLC-MS/MS(API 3000)

Human Plasma


-

194

195

187

190

193

182

186

CAN

ADA

Page 13 of 73


Modified Method


Sr. No.

CitalopramLC-MS/MS (Thermo)

Human Plasma


40 mg

DemethylcitalopramLC-MS/MS (Thermo)

Human Plasma


-

DidemethylcitalopramLC-MS/MS (Thermo)

Human Plasma


-

Citalopram Chiral (R and S)LC-MS/MS(API 3000)

Human Plasma


40 mg

Demethylcitalopram (R and S)

LC-MS/MS(API 3000)

Human Plasma


-

Didemethylcitalopram (S)LC-MS/MS(API 3000)

Human Plasma


-

198 ClarithromycinLC-MS/MS



-

199 Clavulanic AcidLC-MS/MS



125 mg

ClobazamLC-MS/MS (Thermo)

Human Plasma


N-Desmethyl ClobazamLC-MS/MS (Thermo)

Human Plasma


201 ClobazamLC-MS/MS


1 to 400 ng / mL K2EDTA 2 mg / mL

202 ClonazepamLC-MS/MS



-

203 ClonidineLC-MS/MS (Thermo)

Human Plasma


204 ClopidogrelLC-MS/MS (Thermo)

Human Plasma


300 mg

205 Clopidogrel Carboxylic AcidLC-MS/MS (Thermo)

Human Plasma

0.049 to 25 µg / mL K2EDTA 300 mg of Clopidogrel

206 Clopidgorel ThiolLC-MS/MS (Thermo)

Human Plasma

0.1 to 100 ng / mL K2EDTA 300 mg of Clopidogrel

207 CodeineLC-MS/MS (Thermo)

Human Plasma


208 CrisaboroleLC-MS/MS (Thermo)

Human Plasma

0.05 to 100 ng/ mL K2EDTA 2% Ointment(50 mg & 100 mg)

Cyproterone AcetateLC-MS/MS(API 3000)

Human Plasma

0.3 to 25 ng / mLLithium heparin

-

Ethinyl EstradiolLC-MS/MS(API 3000)

Human Plasma

15 to 1280 pg / mLLithium heparin

-

197

196CA

NAD

A 200

209

Page 14 of 73


Modified Method


Sr. No.

210 Cabazitaxel (Total)LC-MS/MS

(Waters QPXE)

Human /Dog

Plasma0.5 to 250 ng / mL K2EDTA

Multiple dosage (0.25 mg/kg to

0.75 mg/kg)

211 Cabazitaxel (Total)LC-MS/MS


0.75 to 500 ng / mL K2EDTA 15 to 25 mg / m2

212 Cabazitexel (Free)LC-MS/MS (Thermo)

Human Plasma

0.05 to 40 ng / mL K2EDTA Multiple dose

213 *CabergolineLC-MS/MS (API 6500)

Human Plasma

0.5 to 80 pg / mL K3EDTA 2 X 0.5 mg

214 CabozanitinibLC-MS/MS



215 CandesartanLC-MS/MS









218 CandesartanLC-MS/MS (API 3200)

Human Plasma

5 to 750 ng/ml K2EDTA 32 mg

219 CapecitabineLC-MS/MS (API 4000)

Human Plasma

10 to 12000 ng / mL K2EDTA 500 mg (multiple dosing)

*Capecitabine LC-MS/MS (Thermo)

Human Plasma


*5-fluorouracilLC-MS/MS (Thermo)

Human Plasma


*CapecitabineLC-MS/MS (Thermo)

Human Plasma

10 to 10000 ng / mL K2EDTA 2X 1250 mg / M2

*5-FluorouracilLC-MS/MS (Thermo)

Human Plasma

5 to 1000 ng / mL K2EDTA 2X 1250 mg / M2

of Capecitabine

Capecitabine LC-MS/MS (API 4000)

Human Plasma


5-Deoxy-5-Fluorocytidine LC-MS/MS (API 4000)

Human Plasma


223S-Methyl N,N-Diethyl dithiocarbamate

LC-MS/MS (Thermo)

Human Plasma


224S-Methyl N,N-Diethyl dithiocarbamate

LC-MS/MS (API 6500)

Human Plasma


225 Carbamazepine LC-MS/MS (API 3200)

Human Plasma

50 to 7000 ng / mL K2EDTA 300 / 400 mg

226 Carbamazepine LC-MS/MS (API 2000)

Human Plasma

0.5 to 20 µg / mL K2EDTA 400 mg (steady state )

Carbamazepine LC-MS/MS (API 2000)

Human Plasma

100 to 7000 ng / mL

K2EDTA 300 / 400 mg

C 10, 11- Epoxide MetaboliteLC-MS/MS (API 2000)

Human Plasma

5 to 500 ng /mL K2EDTA -

I N D

I A

Location : India

220

221

222

227

Page 15 of 73


Modified Method


Sr. No.

228 *CarprofenLC-MS/MS (API 3200)

BeagleDog

Plasma0.5 to 100 µg / mL K2EDTA 100 mg

229 CaptorpilLC-MS/MS



230 CarbidopaLC-MS/MS(Thermo)

Human Plasma


231 CarvedilolLC-MS/MS


0.1 to 100 ng / mL K2EDTA 12.5 mg

*CarvedilolLC-MS/MS (Thermo)

Human Plasma


*4-Hydroxy Phenyl Carvedilol

LC-MS/MS (Thermo)

Human Plasma


*CarvedilolLC-MS/MS



*4-Hydroxy Phenyl Carvedilol


Human Plasma


234 Cefaclor HPLC-UVHuman Plasma

0.2 to 25 µg / mL Heparin 500 mg

235 Cefadroxil HPLC-UVHuman Plasma


236 Cefdinir HPLC-UVHuman Plasma

0.035 to 5 ng / mL Heparin 250 mg

237 Cefixime HPLC-UVHuman Plasma


400 mg

238 CefiximeLC-MS/MS


5 to 3000 ng/mL K2EDTA 50mg granules

239 Ceftazidime HPLC-UVHuman Plasma

0.3 to 60 µg / mL Heparin 1 g injection

240 CefpodoximeLC-MS/MS




0.3 to 35 µg / mL Heparin 750 mg injection



243 CefuroximeLC-MS/MS


0.025 to 7.5 μg / mL K2EDTA 250 mg

244 CelecoxibLC-MS/MS


10 to 4000 ng / mL Heparin 200 mg / 400 mg

245 Cephalexin HPLC-UVHuman Plasma


246 CephalexinLC-MS/MS


0.1 to 50 µg/mL K2EDTA 500 mg

247 Cetrizine LC-MS/MS(Shimadzu

8045)

Human Plasma


10 mg

248 Cetrizine LC-MS/MS (API 3200)

Human Plasma

5 to 500 ng / mL Heparin 10 mg

249 Chlorthalidone HPLC-UVHuman Plasma

10 to 500 ng / mL CPD 25 mg

232

233

I N D

I A

Page 16 of 73


Modified Method


Sr. No.

250 Chlorthalidone HPLC-UVHuman Plasma

50 to 3000 ng / mL CPD 200 mg

251 CilostazolLC-MS/MS (API 2000)

Human Plasma


252 CinacalcetLC-MS/MS (API 3200)

Human Plasma


253 Cinacalcet LC-MS/MS (API 3200)

Human Plasma





255 CimetidineLC-MS/MS



256 CimetidineLC-MS/MS



257 CitalopramHPLC



258 CitalopramLC-MS/MS



*Citalopram (R & S) LC-MS/MS



*S- desmethyl citalopram LC-MS/MS



S-citalopram LC-MS/MS (API 3200)

Human Plasma


S- desmethyl citalopram LC-MS/MS (API 3200)

Human Plasma


S-citalopram LC-MS/MS (API 3200)

Human Plasma


S- desmethyl citalopram LC-MS/MS (API 3200)

Human Plasma


262 S-citalopram LC-MS/MS



263 S-citalopramLC-MS/MS



264 *Citric Acid LC-MS/MS

(Waters QPXE)

Human Urine,Artificial Matrix

5 to 1500 µg / mL N/AP 15mEq

265 ClarithromycinLC-MS/MS (API 3200)

Human Plasma


14- hydroxy ClarithromycinLC-MS/MS (API 3200)

Human Plasma


Clavulanic acidLC-MS/MS


15 to 5000 ng/mLSodium heparin

125 mg

267 Clavulanic acid HPLC-UVHuman Plasma


125 mg

268 ClindamycinLC-MS/MS (API 2000)

Human Plasma


269 ClobazamLC-MS/MS



ClobazamLC-MS/MS (Thermo)

Human Plasma

5 to 600 ng / mL K2EDTA 2.5 mg/mL (total 20 mg)

N-desmethyl clobazam

LC-MS/MS (Thermo)

Human Plasma


259

260

261

266

270

I N D

I A

Page 17 of 73


Modified Method


Sr. No.

271 *ClonidineLC-MS/MS(API 6500)

Human Plasma

2 to 800 ng/ml K2EDTA 0.025 mg/0.2 mg

272 *ClonidineLC-MS/MS (API 6500)

Human Plasma

2 to 250 pg/mL K2EDTA 0.025mg Yes

273 *ClonidineLC-MS/MS (API 6500)

Human Plasma

5 to 2000 pg / mL K2EDTA 0.2mg Yes

274 ClopidogrelLC-MS/MS (API 4000)

Human Plasma

20 to 4000 pg / mL Heparin 75 mg


Human Plasma


300 mg (fasting study)


Human Plasma


300 mg (Fed study)

277 *ClopidogrelLC-MS/MS(Shimadzu

8060)

Human Plasma


75 mg( Fasting)


Human Plasma


75 mg

279 Clopidogrel Carboxy acid LC-MS/MS (API 2000)

Human Plasma

30 to 5000 ng / mL Heparin75 mg of

clopidogrel

280 ClozapineLC-MS/MS


2 to 1200 ng / mL K2EDTA 200 mg multiple dose

281 ClozapineLC-MS/MS



282 Colchicine LC-MS/MS (API 4000)

Human Plasma

25 to 6000 pg / mL K2EDTA 500 mcg

283 CyclophosphamideLC-MS/MS


10 to 2500 ng / mL K2EDTA Multiple dose

284 CycloserineLC-MS/MS (Thermo)

Human Plasma

0.1 to 20 µg / mL K2EDTA 250mg

285 CyproteroneLC-MS/MS



286 DarunavirLC-MS/MS(API 3000)

HumanPlasma


287 DexamethasoneLC-MS/MS (Thermo)

HumanPlasma


288 DextroamphetamineLC-MS/MS (API 3000)

Human Plasma


Dextromethrophan LC-MS/MS (Thermo)

Human Plasma


DetrorphanLC-MS/MS (Thermo)

Human Plasma

0.1 to 50 ng/mL K2EDTA NA

DextromethorphanLC-MS/MS (API 3000)

Human Plasma


30 mg

DextrorphanLC-MS/MS(API 3000)

Human Plasma


-

PseudoephedrineLC-MS/MS(API 3000)

Human Plasma


-

DextromethorphanLC-MS/MS(Thermo)

Human Plasma


PseudoephedrineLC-MS/MS(Thermo)

Human Plasma


BrompheniramineLC-MS/MS(Thermo)

Human Plasma


292 DiclofenacLC-MS/MS(Thermo)

Human Plasma

0.05 to 25 ng / mL K2EDTA 1 % gel

I N D

I A

DLocation : Canada

289

290

291

C A

N A

D A

Page 18 of 73


Modified Method


Sr. No.

293 DidanosineLC-MS/MS(API 3000)

Human Plasma


-

294 DienogestLC-MS/MS(Thermo)

Human Plasma


Diltiazem HPLC-UVHuman Plasma


Desacetyldiltiazem HPLC-UVHuman Plasma


N-Desmethyldiltiazem HPLC-UVHuman Plasma


Diltiazem HPLC-UVHuman Plasma


Desacetyldiltiazem HPLC-UVHuman Plasma


N-Desmethyldiltiazem HPLC-UVHuman Plasma


Diltiazem LC-MS/MS(API 3000)

Human Plasma


DesacetyldiltiazemLC-MS/MS(API 3000)

Human Plasma

0.125 to 32 ng / mL K3EDTA -

N-DesmethyldiltiazemLC-MS/MS(API 3000)

Human Plasma


Diltiazem LC-MS/MS(Thermo)

Human Plasma


DesacetyldiltiazemLC-MS/MS(Thermo)

Human Plasma


N-DesmethyldiltiazemLC-MS/MS(Thermo)

Human Plasma


Diltiazem LC-MS/MS(Thermo)

Human Plasma


DesacetyldiltiazemLC-MS/MS(Thermo)

Human Plasma


N-DesmethyldiltiazemLC-MS/MS(Thermo)

Human Plasma


300 DiphenhydramineLC-MS/MS(API 3000)

Human Plasma


25 to 38 mg

301 DonepezilLC-MS/MS(Thermo)

Human Plasma


302 DoxazosinHPLC



DoxepineLC-MS/MS (Thermo)

Human Plasma


NordoxepineLC-MS/MS (Thermo)

Human Plasma

0.101 to 50.476 ng/mL K2EDTA -

304 Doxycycline HPLC-UVHuman Plasma


305 DuloxetineLC-MS/MS(API 3000)

Human Plasma


306 DuloxetineLC-MS/MS(Thermo)

Human Plasma


307 DutasterideLC-MS/MS(Thermo)

Human Plasma


298

299

303

C A

N A

D A

295

296

297

Page 19 of 73


Modified Method


Sr. No.

308*Dabigatran [Total- (Conjugated + Unconjugated)]

LC-MS/MS (API 3200)

Human Plasma

1 to 500 ng / mL Sodium Citrate 150 mg

309 *Dabigatran (Unconjugated)LC-MS/MS (API 4000)

Human Plasma



Human Plasma



SpragueDawley

Rat plasma5 to 10000 ng / mL Sodium Citrate Multiple dose

312 DaclatasvirLC-MS/MS



313*11-dehydro Thromboxane B2


Human Urine


314 Dalfampridine/FampridineLC-MS/MS (API 3200)

Human Plasma


315 DapsoneLC-MS/MS (API 4000)

Human Plasma

0.05 to 50 ng/mL K2EDTA 5 % gel

316 DapsoneLC-MS/MS (API 4000)

Human Plasma

0.02 to 10 ng/mL K2EDTA 5% gel

317 DarunavirLC-MS/MS


20 to 10000 ng / mL K2EDTA 600 mg / 800 mg

318 DasatinibLC-MS/MS (API 3200)

Human Plasma


3193 De-Methylthiocholchicine 3-O- ß -D-Glucuronide

LC-MS/MS (API 4000)

Human Plasma


3-Demethyl Thiocolchicine LC-MS/MS



3-demethylthiocolchicine 3-O-β-D-Glucuronide


Human Plasma


321 17-Desacetyl NorgestimateLC-MS/MS (API 4000)

Human Plasma

0.05 to 7.5 ng / mL K2EDTA 0.5 mg of norgestimate

322 DexibuprofenLC-MS/MS (API 3200)

Human Plasma


323 DexketoprofenLC-MS/MS (API 2000)

Human Plasma

10 to 10000 ng / mL

K2EDTA 25 mg / 50 mg

324 DexamethasoneLC-MS/MS



325 DeferasiroxLC-MS/MS



326 *DiazepamLC-MS/MS



327 DiazepamLC-MS/MS


2 to 750 ng/mL K2EDTA 5 mg/mL

328 DiclofenacLC-MS/MS (API 2000)

Human Plasma



Human Plasma

10 to 5000 ng / mL Heparin75 mg / 100 mg


Human Plasma



Human Plasma


Location : India

320

I N D

I A

Page 20 of 73


Modified Method


Sr. No.


Human Plasma


333 DienogestLC-MS/MS (API 6500)

Human Plasma


DiltiazemLC-MS/MS



N-Des Methyl DiltiazemLC-MS/MS



Des Acetyl DiltiazemLC-MS/MS



DiltiazemLC-MS/MS



N-Des Methyl DiltiazemLC-MS/MS



Des Acetyl DiltiazemLC-MS/MS



336*2,3-Dinor-6-keto prostaglandin F1α


Human Urine


337 DipyridamoleLC-MS/MS








10 to 4000 ng / mL K2EDTA 200 mg multiple dose

340 DocetaxelLC-MS/MS


10 to 5000 ng / mL K2EDTA 20 mg / 0.5 mL injection

341 Docetaxel (total)LC-MS/MS


10 to 15000 ng / mL K2EDTA Multiple dose

342 *DocetaxelLC-MS/MS

(Waters QPXE)

BeagleDog

Plasma10 to 4000 ng / mL K2EDTA 80mg / 2mL

343 *Docetaxel (free)LC-MS/MS


0.1 to 300 ng / mL K2EDTA Multiple dose

344 DofetilideLC-MS/MS



345 DofetilideLC-MS/MS (API 6500)

Human Plasma


346 DomperidoneLC-MS/MS (API 4000)

Human Plasma


347 DonepezilLC-MS/MS (API 3200)

Human Plasma


DronadaroneLC-MS/MS


0.5 to 200 ng / mL K2EDTA 400 mg (fed study)

N-desbutyl dronadaroneLC-MS/MS



DronadaroneLC-MS/MS (Thermo)

Human Plasma


N-desbutyl dronadaroneLC-MS/MS (Thermo)

Human Plasma


DronedaroneLC-MS/MS


0.2 to 100 ng / mL K2EDTA 400 mg (fasting study)

N-desbutyl Dronedarone LC-MS/MS



351 DrospirenoneLC-MS/MS (API 4000)

Human Plasma


350

334

335

348

349

I N D

I A

Page 21 of 73


Modified Method


Sr. No.

352 DrotaverineLC-MS/MS (Thermo)

Human Plasma


353 DolutegravirLC-MS/MS



354 Doxazosin LC-MS/MS



Doxepin LC-MS/MS (Thermo)

Human Plasma


Nordoxepin LC-MS/MS (Thermo)

Human Plasma


Doxepin LC-MS/MS (Thermo)

Human Plasma


Nordoxepin LC-MS/MS (Thermo)

Human Plasma


357Doxorubicin (Encapsulated and total)


Human Plasma

150 to 60000 ng / mL K3EDTA 50mg / m2

358 *Doxorubicin(Free)LC-MS/MS


4 to 750 ng/mL K3EDTA 50 mg/m2

359 *DoxorubicinolLC-MS/MS (API 6500)

Human Plasma

0.1 to 20 ng / mL K3EDTA 50mg / m2

360 DoxylamineLC-MS/MS (API 3200)

Human Plasma


361 DuloxetineLC-MS/MS (API 3200)

Human Plasma

0.5 to 200 ng/mL Heparin 60 mg

362 DuloxetineLC-MS/MS



60 mg

363 DutasterideLC-MS/MS (API 4000)

Human Plasma

0.05 to 7.5 ng / mL K2EDTA 0.5 mg

364 EfavirenzLC-MS



-

365 EliglustatLC-MS/MS (Thermo)

Human Plasma


EnalaprilLC-MS/MS(API 3000)

Human Plasma


EnalaprilatLC-MS/MS(API 3000)

Human Plasma


HydrochlorthiazideLC-MS/MS(API 3000)

Human Plasma


EnalaprilLC-MS/MS(API 3000)

Human Plasma

0.25 to 256 ng / mL K2EDTA -

EnalaprilatLC-MS/MS(API 3000)

Human Plasma

0.25 to 256 ng / mL K2EDTA -

E

366

367

Location : Canada

355

CAN

ADA

356

I N D

I A

Page 22 of 73


Modified Method


Sr. No.

368 EndoxifenLC-MS/MS (Thermo)

Mice plasma Extract

0.1 to 100 ng/mL K2EDTA 0.2 mg/mL

369 EnrofloxacinLC-MS/MS (Thermo)

Beagle Dog plasma


370 EprosartanLC-MS/MS(Thermo)

Human Plasma


371 EsomeprazoleLC-MS/MS(Thermo)

Human Plasma


372 17 β-EstradiolLC-MS/MS (API 6500)

Human Plasma

1 to 100 pg/mL K2EDTA 0.1 % Gel

373 Etodolac HPLC-UVHuman Plasma

0.25 to 32 µg / mL Heparin -

374 Ethinyl EstradiolLC-MS/MS(Thermo)

Human Plasma


375 Ethinyl EstradiolLC-MS/MS (API 6500)

Human Plasma

0.5 to 125 pg / mL K2EDTA 20 mcg

376 Exemestane LC-MS/MS(API 3000)

Human Plasma


377 ExemestaneLC-MS/MS(Thermo)

Human Plasma


EzetimibeLC-MS/MS (API 6500)

Human Plasma


10 mg

Ezetimibe Phenoxy Glucuronide

LC-MS/MS (API 6500)

Human Plasma


10 mg

EbastineLC-MS/MS (API 3200)

Human Plasma


Carebastine LC-MS/MS (API 3200)

Human Plasma


EbastineLC-MS/MS (API 4000)

Human Plasma



Human Plasma


Ebastine LC-MS/MS (API 4000)

Human Plasma

25 to 12000 pg / mL K2EDTA20 mg Film

Coated/Orodisposable tablet


Human Plasma

1 to 500 ng / mL K2EDTA20 mg Film

Coated/Orodisposable tablet

Ebastine LC-MS/MS



Carebastine LC-MS/MS



383 EfavirenzLC-MS/MS



384 EfavirenzLC-MS/MS (API 4000)

Human Plasma


385 Efavirenz LC-MS/MS (API 4000)

Human Plasma


379

380

381

382

378

Location : India

CAN

ADA

I N D

I A

Page 23 of 73


Modified Method


Sr. No.

386 EliglustatLC-MS/MS (Thermo)

Human Plasma


387 EltrombopagLC-MS/MS (API 4000)

Human Plasma


388 EmpagliflozinLC-MS/MS (API 4000)

Human Plasma


389 Emtricitabine LC-MS/MS (API 4000)

Human Plasma

5 to 5000 ng / mL K2EDTA 200mg Fast/Fed

390 Emtricitabine LC-MS/MS (API 4000)

Human Plasma


391 EndoxifenLC-MS/MS (Thermo)

Human Plasma

25 to 10000 pg /mL K2EDTA 0.5mg to 4.0 mg (Multiple dosing)

392 EndoxifenLC-MS/MS (API 3200)

Human Plasma


EnalaprilLC-MS/MS (Thermo)

Human Plasma

0.5 to 400 ng /mL K2EDTA 10 mg

EnalaprilatLC-MS/MS (Thermo)

Human Plasma

0.5 to 200 ng /mL K2EDTA -

EnalaprilLC-MS/MS (Thermo)

Human Plasma


EnalaprilatLC-MS/MS (Thermo)

Human Plasma


Enalapril LC-MS/MS



Enalaprilat LC-MS/MS



396 EntacaponeLC-MS/MS (API 3200)

Human Plasma


200 mg

397 EplerenoneLC-MS/MS



50 mg

398 EprosartanLC-MS/MS (API 2000)

Human Plasma


399 ErlotinibLC-MS/MS (API 3200)

Human Plasma


400 ErlotinibLC-MS/MS (API 4000)

Human Plasma


401 EslicarbazepineLC-MS/MS (Thermo)

Human Plasma


402 EsomeprazoleLC-MS/MS



403 EsomeprazoleLC-MS/MS



404 EsomeprazoleLC-MS/MS (API 3200)

Human Plasma


405 *Esomeprazole LC-MS/MS

(Waters QPXE)

SpragueDawley Rat

plasma2 to 15000 ng / mL K2EDTA

Multiple dosage (30 mg/kg to 180

mg/kg)

406 *17 β-Estradiol LC-MS/MS (Thermo)

Human Plasma

2 to 100 pg / mL K2EDTA 10 mcg / 20 mcg

393

394

395

I N D

I A

Page 24 of 73


Modified Method


Sr. No.

407 *17 β-Estradiol LC-MS/MS



408 *17 β-Estradiol LC-MS/MS (Thermo)

Human Plasma

2 to 800 pg / mL K2EDTA 0.01 % vaginal cream

409 *17 β-Estradiol LC-MS/MS



*17 β-Estradiol (Unconjugated)

LC-MS/MS(Waters XEVO TQ-S)

Human Plasma

1 to 250 pg / mL K2EDTA 1 mg estradiol

*Estrone (Unconjugated)LC-MS/MS



411 *Estrone (Total)LC-MS/MS


0.3 to 60 ng / mL K2EDTA 1 mg of Estradiol

412 EthosuximideLC-MS/MS



413 *Ethynyl estradiolLC-MS/MS (Thermo)

Human Plasma

2 to 300 pg / mL K2EDTA 0.035mg / 0.07 mg

414 *Ethinyl estradiolLC-MS/MS


0.5 to 200 pg / mL K2EDTA 0.02 mg

415 *Ethinyl Estradiol LC-MS/MS (API 6500)

Human Plasma

0.5 to 125 pg / mL K2EDTA 20 mcg

416 EtoricoxibLC-MS/MS



417 EtravirineLC-MS/MS (API 4000)

Human Plasma

1 to 700 ng/mL K2EDTA 200mg Fast/Fed

418 EverolimusLC-MS/MS

(Shimadzu 8045)Human Blood


419 ExemestaneLC-MS/MS (Thermo)

Human Plasma


25 mg

420 *Ezetimibe (Total)LC-MS/MS


0.5 to 250 ng / mL Sodium Heparin 10 mg

421Ezetimibe (Unconjugated)

LC-MS/MS (API 4000)

Human Plasma


10 mg

422 Ezetimibe (Unconjugated)LC-MS/MS (API 4000)

Human Plasma


EzetimibeLC-MS/MS (API 4000)

HumanPlasma


Ezetimibe Phenoxy Glucuronide

LC-MS/MS (API 4000)

Human Plasma

0.5 to 300 ng / mL Sodium Heparin -

424 Famotidine HPLC-UVHuman Plasma


425 FelodipineLC-MS/MS (Thermo)

Human Plasma


426 Fenofibric acidLC-MS/MS(API 3000)

Human Plasma

50 to 19200 ng / mL K2EDTA 135 mg

427 Fenofibric acid HPLC-UVHuman Plasma

50 to 12800 ng / mLK2EDTA/Sodium

heparin-

C A

N A

D A

Location : CanadaF

I N D

I A

423

410

Page 25 of 73


Modified Method


Sr. No.

428 Fenofibric acid HPLC-UVHuman Plasma


-

429 Fenofibric acidLC-MS/MS (Thermo)

Human Plasma


430 FentanylLC-MS/MS(API 3000)

Human Plasma


-

431 FexofenadineHPLC



-

432 FexofenadineLC-MS/MS



433 FexofenadineLC-MS/MS (Thermo)

Human Plasma


434 FingolimodLC-MS/MS (Thermo)

Human Blood

25 to 500 pg / mL K2EDTA 3 X 0.5 mg

435 Fingolimod PhosphateLC-MS/MS

(Waters QPXE)Human Blood

75 to 4000 pg / mL K2EDTA 3 X 0.5 mg of fingolimod

436 Fluconazole HPLC-UVHuman Plasma


150 mg

FluoxetineLC-MS


0.15 to 37.5 ng / mL Heparin 20 mg

NorfluoxetineLC-MS


0.15 to 37.5 ng / mL Heparin -

FluoxetineLC-MS



-

NorfluoxetineLC-MS



-

439 FlupenthixolLC-MS/MS(API 3000)

Human Plasma


440Fluticasone Propionate

LC-MS/MS (Thermo)

Human Plasma


441Fluticasone Propionate

LC-MS/MS (Thermo)

Human Plasma


442 FluvastatinLC-MS/MS (Thermo)

Human Plasma


443 FluvoxamineLC-MS/MS(API 3000)

Human Plasma


-

444 FulvestrantLC-MS/MS (Thermo)

Dog Plasma


50 mg

445 FulvestrantLC-MS/MS (Thermo)

Human Plasma


446 Fat analysis in food FTIRHuman food & cucumber pulp

1 to 10 g% total fat(expressed as

triglyceride) sample weigh: 0.5 g

NA NA

447 *Fat analysis in food FT-IRHuman food & cucumber pulp

1 to 6 g% total fat (expressed as

triglyceride) Sample weigh:0.5 g

NA60 mg multiple

dose

c A

N A

D A

I N D

I A

437

438

Location : India

Page 26 of 73


Modified Method


Sr. No.

448 Fat analysis in fecal FTIR Human Fecal 0.5 to 15 g% total fat NA 60 mg

449 Febuxostat LC-MS/MS (API 3200)

Human Plasma


450 FebuxostatLC-MS/MS (API 3200)

Human Plasma

10 to 12000 ng / mL K2EDTA 120 mg

451 Fenofibric acid LC-MS/MS (API 3200)

Human Plasma

0.1 to 20 µg / mL K2EDTA 135/160 mg

452 Fenofibric acidLC-MS/MS (API 3200)

Human Plasma

0.1 to 40 μg /mL K2EDTA 267 mg

453 FenspirideLC-MS/MS


2 to 700 ng /mL K2EDTA 80 mg

454 FenspirideLC-MS/MS


5 to 2000 ng /mL K2EDTA 80 mg (steady state)

FesoterodineLC-MS/MS



5-Hydroxymethyl Tolterodine


Human Plasma

20 to 10000 pg / mL K2EDTA -

*Fesoterodine LC-MS/MS

(Waters XEVO TQ-S)

Human Plasma


*5-Hydroxymethyl Tolterodine

LC-MS/MS(Waters

XEVO TQ-S)

Human Plasma

10 to 10000 pg / mL K2EDTA -

457 FinasterideLC-MS/MS








10 to 3000 pg/mL K2EDTA 0.1% Lipid Solution

460 *FingolimodLC-MS/MS (API 4000)

Human Blood

25 to 3000 pg / mL K2EDTA 3 X 0.5 mg

461 FinglolimodLC-MS/MS

(Waters XEVO TQ-S)Human Blood

10 to 1000 pg/mL K2EDTA 0.5mg

462 *Fingolimod PhosphateLC-MS/MS

(Waters XEVO TQ-S)

Human Blood


463 *Fingolimod PhosphateLC-MS/MS (Thermo)

Human Blood


464 *Fingolimod Phosphate LC-MS/MS (API 6500)

Human Blood


465 Flucloxacilin HPLC-UVHuman Plasma

0.3 to 20 µg / mL NA 500 mg

466 FlucloxacillinLC-MS/MS


0.050 to 50 µg / mL K2EDTA 500 mg

467 FlucloxacillinLC-MS/MS



468 FluconazoleLC-MS/MS (API 2000)

Human Plasma

50 to 10000 ng / mL

K2EDTA 150 mg

I N D

I A

455

456

Page 27 of 73


Modified Method


Sr. No.

FluoxetineLC-MS/MS (API 4000)

Human Plasma


NorfluoxetineLC-MS/MS (API 4000)

Human Plasma


470 FluoxetineLC-MS/MS (API 3200)

Human Plasma



Human Plasma



Human Plasma


473*Fluticasone Propionate

LC-MS/MS(Waters

XEVO TQ-S)

Human Plasma

2 to 200 pg / mL K2EDTA 500 µg

474 *FluticasoneLC-MS/MS


1 to 200 pg/mL K2EDTA 500 µg

475 Fluvastatin LC-MS/MS (API 4000)

Human Plasma

0.5 to 500 ng / mL Heparin40 mg / 80 mg

476 *Fluvastatin (R & S)LC-MS/MS (API 4000)

Human Plasma


477 *Fluvastatin (R & S)LC-MS/MS (API 4000)

Human Plasma


478 *FormoterolLC-MS/MS


0.4 to 150 pg/mL K2EDTA 24 µg

479 FosfomycinLC-MS/MS (Thermo)

Human Plasma

0.6 to 80 ng/mL K2EDTA 5.631mg

480 FulvestrantLC-MS/MS



481 FurosemideLC-MS/MS (API 3200)

Human Plasma


482 FurosemideLC-MS/MS (API 3200)

Human Plasma


483 GabapentinLC-MS/MS(API 3000)

Human Plasma


484 GalantamineLC-MS/MS(API 3000)

Human Plasma


485 GanciclovirHPLC



486 GatifloxacinHPLC



487 GlimepirideLC-MS/MS



488 Glipizide HPLC-UVHuman Plasma


C A

N A

D A

469I N

D I

A

GLocation : Canada

Page 28 of 73


Modified Method


Sr. No.

489 GlipizideLC-MS



490 GlipizideLC-MS/MS



491 GlipizideLC-MS/MS(API 3000)

Human Plasma


492 GlyburideLC-MS



493 GriseofulvinLC-MS/MS



494 GranisetronLC-MS/MS (Thermo)

Human Plasma


495 Guaifenesin LC-MSHuman Plasma


496 GuaifenesinLC-MS/MS (Thermo)

Human Plasma

10 to 5120 ng/mL K2EDTA -

497 GabapentinLC-MS/MS (API 3200)

Human Plasma

50 to 7500 ng / mL K2EDTA 400 / 800 mg


Human Plasma

150 to 10000 ng / mL K2EDTA 1200 / 800 mg


Human Plasma


500 Galantamine LC-MS/MS



501 GefitinibLC-MS/MS


0.75 to 350 ng / mL K2EDTA 250 mg

502 GefitinibLC-MS/MS



503 GemcitabineLC-MS/MS (API 3200)

Human Plasma

0.1 to 35 µg / mLK2EDTA /

Sodium heparin1000 mg / m2

504 *GestodeneLC-MS/MS (API 6500)

Human Plasma

30 to 6000 pg/mL K2EDTA 0.06 & 0.075

505 GliclazideLC-MS/MS (API 3200)

Human Plasma



Human Plasma



Human Plasma



Human Plasma


509 Glimepiride LC-MS/MS (API 2000)

Human Plasma


I N D

I A

Location : India

C A

N A

D A

Page 29 of 73


Modified Method


Sr. No.

510 GlimepirideLC-MS/MS (API 3200)

Human Plasma


511 GlipizideLC-MS/MS



512 *GlucagonLC-MS/MS

(Waters XEVO TQ-S)

Human Plasma

0.2 to 10 ng / mL K2EDTA 1 mg/vial

513 GlucosaminLC-MS/MS (Thermo)

Human Plasma


514 *GlycopyrroniumLC-MS/MS

(Waters XEVO TQ-S)

Human Plasma


515 *GoserelinLC-MS/MS (API 6500)

Human Plasma

50 to 10000 pg/mL K2EDTA 3.6mg Yes

516 GuaifenesinLC-MS/MS (API 4000)

Human Plasma


517 HydrocodoneLC-MS/MS (Thermo)

Human Plasma

0.4 to 51 ng / mL K2EDTA 7.5 mg / 5 mL

HydrocodoneLC-MS/MS(API 3000)

Human Plasma


-

HydromorphoneLC-MS/MS(API 3000)

Human Plasma


-

IbuprofenLC-MS/MS(API 3000)

Human Plasma

100 to 12800 ng / mL

Sodium heparin

-

HydralazineLC-MS/MS (Thermo)

Human Plasma


hydralazine pyruvic acid hydrazone (HPH)

LC-MS/MS (Thermo)

Human Plasma


520 HydrochlorthiazideLC-MS


5 to 1280 ng / mL K2EDTA 12.5 mg to 25 mg

521 HydromorphoneLC-MS/MS(Thermo)

Human Plasma


522 HydromorphoneLC-MS/MS (Thermo)

Human Plasma


523 Haloperidol LC-MS/MS (API 6500)

Human Plasma

5 to 2500 pg/mL K2EDTA -

524 HaloperidolLC-MS/MS (API 6500)

Human Plasma


525 HRF-4467 LC-MS/MS



526 HRF-4467 LC-MS/MS



I N D

I A

I N D

I A

Location : India

H

518

519

Location : Canada

C A

N A

D A

Page 30 of 73


Modified Method


Sr. No.

527 HydralazineLC-MS/MS



528 HydrochlorothiazideLC-MS/MS (API 4000)

Human Plasma

1 to 300 ng / mL K2EDTA 25 mg / 12.5 mg


Human Plasma



Human Plasma


HydrochlorthiazideLC-MS/MS


1 to 400 ng / mL K2EDTA 12.5 mg / 25 mg

Telmisartan LC-MS/MS



HydrochlorthiazideLC-MS/MS (Thermo)

Human Plasma

1 to 400 ng / mL K2EDTA 12.5 mg / 25 mg

Telmisartan LC-MS/MS (Thermo)

Human Plasma


HydrochlorthiazideLC-MS/MS (API 6500)

HumanPlasma


Telmisartan LC-MS/MS (API 6500)

HumanPlasma

2 to 1000 ng/mLK2EDTA 80 mg

HydrochlorothiazideLC-MS/MS (API 4000)

Human Plasma



Human Plasma


535 HydrocortisoneLC-MS/MS(API 3200)

HumanUrine

0.25 to 100 ng / mL Not applicable -

536 *HydrocortisoneLC-MS/MS



537 HydroxychloroquineLC-MS/MS (API 3200)

Human Blood


538 5-HydroxytryptophanLC-MS/MS (API 4000)

Human Plasma


539 Hyosciene ButylLC-MS/MS(Shimadzu

8060)

Human Plasma


540 Ibuprofen HPLC-UVHuman Plasma


200 mg

541 IbuprofenLC-MS/MS(API 6500)

Human Plasma

0.1 to 40 µg/mL Sodium Heparin 200mg

542 IbuprofenLC-MS/MS



IbuprofenLC-MS/MS (Thermo)

Human Plasma


MethocarbamolLC-MS/MS (Thermo)

Human Plasma


544 ImatinibLC-MS/MS (Thermo)

Human Plasma


I

533

C A

N A

D A

I N D

I A

531

532

534

Location : Canada

543

Page 31 of 73


Modified Method


Sr. No.

545 Indapamide HPLC-UVHumanWholeBlood


ItraconazoleLC-MS/MS



Hydroxy ItraconazoleLC-MS/MS

(API 300or 3000)Human Plasma


ItraconazoleLC-MS/MS(API 3000)

Human Plasma


Hydroxy ItraconazoleLC-MS/MS(API 3000)

Human Plasma


Ivabradine LC-MS/MS



N-desmethyl Ivabradine


Human Plasma

20 to 2480 ng / mL K2EDTA 15 mg of Ivabradine

549 S-KetrolacLC-MS/MS (Thermo)

Human Plasma


550 *IbandronateLC-MS/MS (Thermo)

Human Plasma


551 *IbandronateLC-MS/MS (API 4000)

Human Plasma


552 *Ibuprofen (R & S)LC-MS/MS


0.1 to 50 µg/ mL Heparin 600 mg

553 *Ibuprofen (R & S)LC-MS/MS


0.1 to 25 μg/mL Sodium heparin

200mg

554 Ibuprofen HPLC-UVHuman Plasma

1 to 100 µg / mL Heparin 800 mg

555 Ibuprofen LC-MS/MS (API 3200)

Human Plasma


100mg & 200mg

556 IbuprofenLC-MS/MS (API 3200)

Human Plasma


557 ImatinibLC-MS/MS






559 ImatinibLC-MS/MS (API 4000)

Human Plasma




10 to 7000 ng/mL K2EDTA400 mg single and

400mg multiple dose

ImatinibLC-MS/MS



N-Desmethyl ImatinibLC-MS/MS



ImatinibLC-MS/MS


5 to 3000 ng / mL Lithium Heparin 400 mg



2 to 400 ng / mL Lithium Heparin -

ImatinibLC-MS/MS






547

C A

N A

D A

562

I N D

I A

563

Location : India

546

548

561

Page 32 of 73


Modified Method


Sr. No.

564 IrbesartanLC-MS/MS (API 3200)

Human Plasma

10 to 10000 ng / mL

Sodium heparin

300 mg

Iron Sucrose (Total Iron)

Vitros 5.1,FSHumanSerum

100.050 to 4504.500 µg/mL

Iron Sucrose(Transferrin Bound Iron)

Vitros 5.1,FSHumanSerum

20.007 to 560.560µg/mL

Itraconazole LC-MS/MS

(Waters QPXE)HumanSerum


OH-ItraconazoleLC-MS/MS



ItraconazoleLC-MS/MS (API 4000)

Human Plasma


100 mg

Hydroxy ItraconazoleLC-MS/MS (API 4000)

Human Plasma


-

568 IsosorbideLC-MS/MS(Shimadzu

8060)

Human Plasma


569 *IsotretinoinLC-MS/MS (API 4000)

Human Plasma


570 IsotretinoinLC-MS/MS(Shimadzu

8060)

Human Plasma


571 *IsotretinoinLC-MS/MS(Shimadzu

8060)

Human Plasma

0.5 to 600 ng / mL K2EDTA 40 mg ( fasting study)

572 IsoniazidLC-MS/MS


50 to 10000 ng / mL K2EDTA 300mg/200 mg/100 mg

573 IsoniazidLC-MS/MS



574 *IsotretinoinLC-MS/MS

(Waters QPXE)

SpragueDawley Rat

Skin0.75 to 500 ng / mL NA NA

575 *IsotretinoinLC-MS/MS

(Waters QPXE)Rabbit

Skin0.75 to 500 ng / mL NA NA

576 IvabradineLC-MS/MS (API 3200)

Human Plasma


577 IvermectinLC-MS/MS (Thermo)

Human Plasma


578 3-KetodesogestrelLC-MS/MS (Thermo)

Human Plasma

20 to 5000 pg / mL K2EDTA 0.3 mg of desogestrel

579 *6-Keto prostaglandin F1αLC-MS/MS(Shimadzu

8040)

Human Urine


580 KetoconazoleHPLC


0.05 to 5 µg / mL CPD 200 mg

565 NA 20mg/mL

566

567

INDI

AI N

D I

A

K

Location : India

Page 33 of 73


Modified Method


Sr. No.

581 LabetalolLC-MS/MS (Thermo)

HumanPlasma


582 LamotrigineLC-MS/MS (Thermo)

Human Plasma


50 mg

583 LansoprazoleLC-MS/MS



30 mg

584 LeuprolideLC-MS/MS (Thermo)

Human Plasma

0.025 to 13 ng / mL K2EDTA -

585 LetrozoleLC-MS/MS(API 3000)

Human Plasma


586 LevetiracetamLC-MS



587 LevetiracetamLC-MS/MS(API 3000)

Human Plasma


588 LisinoprilLC-MS/MS



-






1 to 256 ng / mLLithium heparin

-

591 LoperamideLC-MS/MS (Thermo)

Human Plasma


LoratadineLC-MS/MS (API 3000)

Human Plasma


DescarboethoxyloratadineLC-MS/MS (API 3000)

Human Plasma


PseudoephedrineLC-MS/MS (API 3000)

Human Plasma


LoratadineLC-MS/MS



DescarboethoxyloratadineLC-MS/MS



Loratadine LC-MS/MS (API 6500)Human Plasma

5 to 5000 pg / mL K2EDTA 5mg

DescarboethoxyloratadineLC-MS/MS (API 6500)

Human Plasma

10 to 10000 pg / mL K2EDTA -


Human Plasma

2.5 to 1250 ng / mL K2EDTA 120 mg

LoratadineLC-MS/MS (API 6500)

Human Plasma


DesloratadineLC-MS/MS (API 6500)

Human Plasma

40 to 12000 pg/mL K2EDTA N/AP


Human Plasma


C A

N A

D A

593

594

595

L

Location : Canada

592

Page 34 of 73


Modified Method


Sr. No.

596 LormetazepamLC-MS/MS (Thermo)

Human Plasma


LosartanLC-MS/MS (API 3000)

Human Plasma


Losartan Hydroxy AcidLC-MS/MS (API 3000)

Human Plasma


LovastatinLC-MS/MS



Lovastatin Hydroxy Acid LC-MS/MS



599 LacidipineLC-MS/MS (API 4000)

Human Plasma


600 LacosamideLC-MS/MS (API 3200)

Human Plasma

25 to 10000 ng / mL K2EDTA 200 mg

601 LamivudineLC-MS/MS (API 2000)

Human Plasma


602 LamivudineLC-MS/MS (Thermo)

Human Plasma


LamivudineLC-MS/MS



ZidovudineLC-MS/MS



604 LamotrigineLC-MS/MS (API 3200)

Human Plasma


605 LamotrigineLC-MS/MS (Thermo)

Human Plasma


606 Lansoprazole LC-MS/MS (API 3200)

Human Plasma


30 mg

607 LapatinibLC-MS/MS (API 2000)

Human Plasma

15 to 6000 ng / mL K2EDTA 1250 mg

LedipasvirLC-MS/MS (API 4000)

Human Plasma


Sofosbuvir LC-MS/MS (API 4000)

Human Plasma


609 LenalidomideLC-MS/MS (API 3200)

Human Plasma


610 LenalidomideLC-MS/MS (API 3200)

Human Plasma


611 LercanidipineLC-MS/MS (API 3200)

Human Plasma


612 *Lercanidipine ( R& S)LC-MS/MS



10 mg

613 *Lercanidipine (R & S)LC-MS/MS



Location : India

603

C A

N A

D A

I N D

I A

597

598

608

Page 35 of 73


Modified Method


Sr. No.

614 *Lercanidipine (R & S)LC-MS/MS


10 to 16000 pg / mL Sodium heparin

20 mg

615 LetrozoleLC-MS/MS (API 3200)

Human Plasma

1 to 80 ng / mL Heparin 2.5 mg

616 LevetiracetamLC-MS/MS (API 3200)

Human Plasma


617 LevetiracetamLC-MS/MS (Thermo)

Human Plasma 0.25 to 25 µg /mL Sodium

heparin750 mg

618 LevocetirizineLC-MS/MS



LevodopaLC-MS/MS (Thermo)

Human Plasma


CarbidopaLC-MS/MS (Thermo)

Human Plasma


LevodopaLC-MS/MS (API 4000)

Human Plasma


CarbidopaLC-MS/MS (API 4000)

Human Plasma


LevodopaLC-MS/MS (Thermo)

Human Plasma


CarbidopaLC-MS/MS (Thermo)

Human Plasma

0.5 to 100 ng / mL K2EDTA 12.5 mg

622 Levofloxacin HPLC-UVHuman Plasma


623 LevofloxacinLC-MS/MS



624 LevonorgestrelLC-MS/MS (API 4000)

Human Plasma



Human Plasma



Human Plasma

0.05 to 15 ng / mL K2EDTA 0.15 mg

627 LevonorgestrelLC-MS/MS


20 to 15000 pg/mL K2EDTA -

628*Levosalbutamol (Levabuterol)


Human Plasma

2 to 750 pg/mL K2EDTA 45X2 µg

629 *Levothyroxin (T4)LC-MS/MS (API 3200)

HumanSerum

5 to 300 ng / mL NA 600 mcg

630 LevothyroxineLC-MS/MS

(Shimadzu 8045)Human Serum

5 to 300 ng/mL NA 600 mcg

631 LinagliptinLC-MS/MS


0.1 to 10 ng / mL K2EDTA 2.5 mg / 5 mg

632 LinagliptinLC-MS/MS



633 Linezolid LC-MS/MS (API 3200)

Human Plasma

50 to 25000 ng / mL

K2EDTA 600 mg

I N D

I A

621

619

620

Page 36 of 73


Modified Method


Sr. No.




635 LisinoprilLC-MS/MS (Thermo)

Human Plasma





637 Lisinopril LC-MS/MS



638 Lisinopril LC-MS/MS



639 Lithium Carbonate Vitros 5.1,FSHumanSerum

0.274 to 3.754 mol/L NA 450mg

Lofepramine LC-MS/MS (API 4000)

Human Plasma


Desipramine LC-MS/MS (API 4000)

Human Plasma


641 LoperamideLC-MS/MS (Thermo)

Human Plasma

15 to 2500 pg / mL K2EDTA 2X2mg Yes

LopinavirLC-MS/MS



Ritonavir LC-MS/MS



LopinavirLC-MS/MS


30 to 20000 ng / mL K2EDTA 400 mg

RitonavirLC-MS/MS


2.5 to 1600 ng / mL K2EDTA 100 mg

Lopinavir LC-MS/MS

(Waters XEVO TQS)Human Plasma


RitonavirLC-MS/MS

(Waters XEVO TQS)Human Plasma


LopinavirLC-MS/MS



RitonavirLC-MS/MS



646 LornoxicamLC-MS/MS



647 LoratadineLC-MS/MS



Loratadine LC-MS/MS (API 6500)

Human Plasma


Desloratadine LC-MS/MS (API 6500)

Human Plasma

25 to 10500 pg / mL K2EDTA -

Losartan LC-MS/MS (API 2000)

Human Plasma

5 to 1200 ng / mL K2EDTA / Heparin

-

Losartan carboxylic acidLC-MS/MS (API 2000)

Human Plasma


-

Losartan LC-MS/MS (API 2000)

Human Plasma



Human Plasma


648

649

650

640

642

643

644

I N D

I A

645 Yes

Page 37 of 73


Modified Method


Sr. No.


Human Plasma



Human Plasma

3 to 2200 ng/mL K2EDTA -

652 Losartan LC-MS/MS (API 3200)

Human Plasma


653 LosartanLC-MS/MS (API 3200)

Human Plasma


LosartanLC-MS/MS



Losartan Carboxylic AcidLC-MS/MS



HydrochlorthiazideLC-MS/MS




Human Plasma



Human Plasma


S-amlodipineLC-MS/MS (API 4000)

Human Plasma


656 *15-hydroxy lubiprostone LC-MS/MS


1 to 100 pg / mL K2EDTA 48 mcg of lubiprostone

657 LumefantrineLC-MS/MS (API 4000)

Human Plasma

50 to 20250 ng / mL K2EDTA 480 mg

658 LurasidoneLC-MS/MS (API 4000)

Human Plasma


659 LurasidoneLC-MS/MS (API 3200)

Human Plasma


660 LurasidoneLC-MS/MS(API 6500)

Human Plasma


661 LurasidoneLC-MS/MS



*LurasidoneLC-MS/MS (API 4000)

Human Plasma


*Lurasidone 14283LC-MS/MS (API 4000)

Human Plasma


*Lurasidone 14326 LC-MS/MS (API 4000)

Human Plasma


663 MeclizineLC-MS/MS (API 3000)

Human Plasma


664 Mefanamic Acid HPLC-UVHuman Plasma


665 Mefanamic AcidLC-MS/MS (API 3000)

Human Plasma

50 to 12800 ng / mL K2EDTA 250 mg

666Medroxyprogesterone Acetate

LC-MS/MS (API 3000)

Human Plasma


-

667Medroxyprogesterone Acetate

LC-MS/MS (Thermo)

Human Plasma


150 mg

655

662

651 Yes

654

Location : Canada

M

I N D

I A

CAN

ADA

Page 38 of 73


Modified Method


Sr. No.

668 Megestrol AcetateLC-MS/MS (Thermo)

Human Plasma

0.3 to 153.6 ng/mL K2EDTA 40 mg / mL

669 Meloxicam HPLC-UV

HumanPlasma or

DogPlasma

0.03 to 1.92 µg / mL K2EDTA -

670 MeloxicamLC-MS/MS (API 3000)

Human Urine

1 to 128 ng / mLNot

applicable-


Human Plasma


672 Metaxalone HPLC-UVHuman Plasma

1 to 256 µg / mL Heparin -

673 Metaxalone HPLC-UVHuman Plasma

1 to 256 µg / mL K3EDTA -

674 Metaxalone LC-MS (API 150)Human Plasma


675 MethylphenidateLC-MS/MS (Thermo)

Human Plasma



Human Plasma

0.1 to 50 ng/mLSodium Fluoride & Potassium Oxalate

54mg


Human Plasma


L-Threo-Methylphenidate

LC-MS/MS (API 6500)Human Plasma


D-Threo-Methylphenidate

LC-MS/MS (API 6500)Human Plasma

25 to 9800 pg/mL K2EDTA NA

679 Methylphenidate AchiralLC-MS/MS (Thermo)

Human Plasma


Methylphenidate Chiral(L&D)

LC-MS/MS (API 6500)

Human Plasma

100 to 30000 pg/mL(D)

K2EDTA 54 mg


LC-MS/MS (API 6500)

Human Plasma

50 to 4000 pg/mL(L) K2EDTA 54 mg


LC-MS/MS (Thermo)

Human Plasma

15 to 3000 pg/mL (L)Sodium fluoride & Potassium oxalate

60 mg


LC-MS/MS (Thermo)

Human Plasma

200 to 40000 pg/mL (D)

Sodium fluoride & Potassium oxalate

60 mg

682 MethylprednisoloneLC-MS/MS (API 3000)

Human Plasma

0.4 to 51 ng / mLSodium fluoride

potassium oxalate -

683 MethylprednisoloneLC-MS/MS(API 6500)

Human Plasma

0.4 to 75 ng/mLSodium Fluoride & Potassium Oxalate

80mg/mL Injectable

suspension

684 MetoprololLC-MS/MS (API 3000)

Human Plasma


200 mg

685 MetforminLC-MS/MS (API 3000)

Human Plasma

10.01 to 2002 ng / mL

K2EDTA 1000 mg

686 MetforminLC-MS

(API 150)Human Urine

2 to 256 µg / mLNot

applicable1000 mg

687 MethazolamideLC-MS/MS



688 MethazolamideLC-MS/MS

(Waters QPXE)

HumanWholeBlood

100 to 50000 ng / mL K2EDTA 150 mg

689 MethazolamideLC-MS/MS (Thermo)

Human Plasma


680

678

681

CAN

ADA

Page 39 of 73


Modified Method


Sr. No.

690 MinocyclineLC-MS/MS (Thermo)

Human Plasma

4 to 3500 ng / mL K2EDTA 45 mg to 135 mg

691 MirtazapineLC-MS/MS



-

Misoprostol AcidLC-MS/MS (Thermo)

Human Plasma

10 to 1280 pg / mLLithium heparin

-

DiclofenacLC-MS/MS (Thermo)

Human Plasma

20 to 2560 ng / mLLithium heparin

-

693 Monomethyl fumarateLC-MS/MS (API 6500)

Human Plasma


Monomethyl fumarateLC-MS/MS (Thermo)

Human Plasma

20 to 5000 ng / mL K2EDTA 240 mg DMF

Monoethyl fumarateLC-MS/MS (Thermo)

Human Plasma

20 to 5000 ng / mL K2EDTA

695 Mycophenolic Acid HPLC-UVHuman Plasma


Mycophenolate MofetilLC-MS/MS (Thermo)

Human Plasma


Mycophenolic Acid LC-MS/MS (Thermo)

Human Plasma


6976-Methoxy-2-Naphthaleneacetic Acid

HPLC - Flurosence

Human Plasma


698 MebendazoleLC-MS/MS (API 4000)

HumanPlasma


Mebeverine acidLC-MS/MS


1 to 1000 ng / mL K2EDTA 135 mg of Mebeverine

Desmethyl Mebeverine acidLC-MS/MS



Mebeverine acidLC-MS/MS (API 4000)

Human Plasma


Desmethyl mebeverine acidLC-MS/MS (API 4000)

Human Plasma


Veratric acidLC-MS/MS (API 4000)

Human Plasma


701*Medroxy Progesterone Acetate

LC-MS/MS (Thermo)

Human Plasma

50 to 8000 pg / mL Sodium Heparin 150 mg

702 Medroxy ProgesteroneLC-MS/MS



150 mg

703 Mefenamic Acid LC-MS/MS



704 Megestrol AccetateLC-MS/MS (API 3200)

Human Plasma


705 MelatoninLC-MS/MS (API 4000)

Human Plasma


706 MelatoninLC-MS/MS (API 6500)

Human Plasma


707 Meloxicam LC-MS/MS




Human Plasma


692

699

700

I N D

I A

696

Location : India

694CAN

ADA

Page 40 of 73


Modified Method


Sr. No.

709 MemantineLC-MS/MS






711 MemantineLC-MS/MS (API 3200)

Human Plasma








714 MesalamineLC-MS/MS



715 MesalamineLC-MS/MS


5 to 3000 ng / mL K2EDTA 1.2 gm

716 MesalamineLC-MS/MS (API 4000)

Human Plasma

2 to 700 ng / mL K2EDTA 1000 mg rectal suppository

Mesalamine LC-MS/MS (Thermo)

Human Plasma


N-Acetyl Mesalamine LC-MS/MS (Thermo)

Human Plasma


718 MetforminLC-MS/MS



500 mg

719 MetforminLC-MS/MS



1000 mg

720 MetforminLC-MS/MS (API 3200)

Human Plasma


500mg

721 MethazolamideLC-MS/MS (Thermo)

Human Blood


722 MethimazoleLC-MS/MS



723 MethocarbamolLC-MS/MS (Thermo)

Human Plasma


724 MethocarbamolLC-MS/MS (API 4000)

Human Plasma

0.05 to 20 µg/mL K2EDTA 750mg/500mg Yes

725 MethotrexateLC-MS/MS



726 4-Methyl aminoantipyrine LC-MS/MS



*L-MethylphenidateLC-MS/MS


50 o 4000 pg / mL K2EDTA 54 mg

*D-MethylphenidateLC-MS/MS


100 to 20000 pg / mL

K2EDTA 54 mg

728 MethylprednisoloneLC-MS/MS (API 4000)

Human Plasma

0.4 to 50 ng/mLSodium fluoride and Potassium oxalate

80 mg/mL (Multi Dose Vials)

729 Methylprednisolone LC-MS/MS (API 4000)

Human Plasma


4 mg

730 MetoclopramideLC-MS/MS (API 4000)

Human Plasma

0.25 to 50 ng/mL K2EDTA 5 mg/5 mL oral solution


Human Plasma

0.3 to 50 ng /mL Heparin 23.75 mg

I N D

I A

727

717

Page 41 of 73


Modified Method


Sr. No.

732 Metoprolol LC-MS/MS (API 3200)

Human Plasma

0.2 to 100 ng /mL Heparin47.5 / 50 mg


Human Plasma


100mg Yes

734 Metoprolol LC-MS/MS (API 3200)

Human Plasma

0.75 to 300 ng /mL Sodium Heparin100 /

200 mg

MifepristoneLC-MS/MS (Thermo)

Human Plasma


N-desmethyl Mifepristone

LC-MS/MS (Thermo)

Human Plasma


N, N-didesmethyl mifepristone

LC-MS/MS (Thermo)

Human Plasma


Hydroxy mifepristoneLC-MS/MS (Thermo)

Human Plasma


736 MilnacipranLC-MS/MS (Thermo)

Human Plasma


737 MiltefosineLC-MS/MS


10 to 2500 ng / mL K2EDTA 100/150 mg

738 MinocyclineLC-MS/MS



739 MinocyclineLC-MS/MS



740 MinoxidilLC-MS/MS (API 4000)

Human Serum

50 to 4000 pg / mL NA 5% lipid solution

741 MirabegroneLC-MS/MS (API 3200)

Human Plasma


742 MirabegronLC-MS/MS (API 4000)

Human Plasma


743 Misoprostol Acid LC-MS/MS (API 6500)

Human Plasma

5 to 750 pg / mL K2EDTA 0.2 mg (fed study)

744 *Misoprostol Acid LC-MS/MS (API 4000)

Human Plasma

10 to 1700 pg / mL K2EDTA 0.2 mg ( fasting study)

745 MoexiprilLC-MS/MS (API 4000)

Human Plasma


746 Monomethyl FumarateLC-MS/MS


10 to 6000 ng / mL K2EDTA 240 mg DMF

747 Monomethyl Fumarate LC-MS/MS (API 6500)

Human Plasma


748 Monomethyl Fumarate LC-MS/MS



749 MonoxidineLC-MS/MS (Thermo)

Human Plasma

30 to 7500 pg/mL K2EDTA 400 µg

750 MontelukastLC-MS/MS (API 3200)

Human Plasma


751 MontelukastLC-MS/MS (API 3200)

Human Plasma


752 MoxifloxacinLC-MS/MS



753 MoxifloxacinLC-MS/MS (API 4000)

Human Plasma


400 mg

I N D

I A

735

Page 42 of 73


Modified Method


Sr. No.

Mycophenolate Mofetil LC-MS/MS



Mycophenolic AcidLC-MS/MS



Mycophenolate mofetil LC-MS/MS



Mycophenolic acidLC-MS/MS


75 to 25000 ng / mL

K2EDTA -

Mycophenolate Mofetil LC-MS/MS


0.05 to 10 ng/mL K2EDTA250 mg

(Bufferisesd plasma)

Mycophenolic Acid LC-MS/MS


80 to 40000 ng/mL K2EDTA250 mg

(Bufferisesd plasma)

757 Mycophenolic acidLC-MS/MS



758 Mycophenolic acidLC-MS/MS


25 to 15000 ng / mL

K2EDTA 180 mg

759 Mycophenolic acidLC-MS/MS (API 3200)

Human Plasma


Mycophenolate mofetil LC-MS/MS


0.05 to 20 ng / mL K2EDTA 1 gm

Mycophenolic acidLC-MS/MS


100 to 50000 ng / mL

K2EDTA -

NadololLC-MS/MS (API 3000)

Human Plasma


BendroflumethiazideLC-MS/MS (API 3000)

Human Plasma


762 NaloxoneLC-MS/MS (API 6500)

Human Plasma


Naloxone-3-β-D-GlucuronideLC-MS/MS (API 6500)

Human Plasma


OxycodoneLC-MS/MS (API 6500)

Human Plasma


Naltrexone LC-MS/MS (API 3000)

Human or Dog

Plasma0.1 to 205 ng / mL

Sodium heparin for human plasma; K3EDTA for dog

plasma

50 mg

6-ß-NaltrexolLC-MS/MS (API 3000)

Human or Dog

Plasma0.1 to 205 ng / mL

Sodium heparin for human plasma; K3EDTA for dog

plasma

-

NaltrexoneLC-MS/MS (API 3000)

Human Urine

1 to 512 ng / mLNot

applicable-

6-ß-NaltrexolLC-MS/MS (API 3000)

Human Urine

9.947 to 5092 ng / mL

Not applicable

-

766 Naproxen HPLC - FlurosenceHuman Plasma


767 NebivololLC-MS/MS (API 6500)

Human Plasma


I N D

I A

C A

N A

D A

754

755

760

756

Location : Canada

761

763

764

765

N

Page 43 of 73


Modified Method


Sr. No.

Nefazodone LC-MS (API 150)Human Plasma


2-Hydroxynefazodone LC-MS (API 150)Human Plasma


m-Chlorophenylpiperazine

LC-MS (API 150)Human Plasma


NiacinLC-MS/MS (Thermo)

Human Plasma

20 to 2000 ng / mL K2EDTA 1000 mg

Nicotinuric acidLC-MS/MS (Thermo)

Human Plasma


770 Nifedipine LC-MS (API 150)Human Plasma


771 NifedipineLC-MS/MS (API 3000)

Human Plasma


772 NintedanibLC-MS/MS (Thermo)

Human Plasma

0.050- 20 ng/mL K2EDTA 150mg

773 Nitrofurantoin HPLC-UVHuman Plasma


-

774 NitrofurantoinLC-MS/MS (Thermo)

Human Plasma

5 to 1000 ng/mL K2EDTA 25mg/5mL suspension

Nizatidine HPLC-UVHuman Plasma


Desmethylnizatidine HPLC-UVHuman Plasma


776 Norfloxacin HPLC - FlurosenceHuman Plasma


777 Nortriptyline HPLC-UVHuman Plasma


778 NorethindroneLC-MS/MS (Thermo)

Human Plasma

50 to 15000 pg / mL K2EDTA 0.35 mg / 1 mg

779 RS-NorketotifenLC-MS/MS (Thermo)

Human Plasma


S-NorketotifenLC-MS/MS (Thermo)

Human Plasma

1 - 1000 ng/mL K2EDTA 4 mg/8mg/16mg

R- NorketotifenLC-MS/MS (Thermo)

Human Plasma

1 - 1000 ng/mL K2EDTA NA

781 *NabiloneLC-MS/MS (Thermo)

Human Plasma


782 NadololLC-MS/MS (API 4000)

Human Plasma


783 NadololLC-MS/MS (API 3200)

Human Plasma


784 NaloxegolLC-MS/MS



785 NaltrexoneLC-MS/MS



Naltrexone LC-MS/MS


0.1 to 20 ng /mL Heparin 50 mg

6 beta NaltrexolLC-MS/MS



Location : India

786

768

769

I N D

I A

C A

N A

D A

775

780

Page 44 of 73


Modified Method


Sr. No.

Naltrexone LC-MS/MS


0.5 to 50 ng /mL Heparin 100 mg

6 beta NaltrexolLC-MS/MS



788 NaratriptanLC-MS/MS (API 3200)

Human Plasma

0.1 to 20 ng / mL Heparin 2.5 mg

789 NaproxenLC-MS/MS (API 2000)

Human Plasma

500 to 50000 ng /mL

K2EDTA 200 mg

790 NaproxenLC-MS/MS



NaproxenLC-MS/MS



Esomeprazole LC-MS/MS



NaproxenLC-MS/MS



Esomeprazole LC-MS/MS



793 NateglinideLC-MS/MS (API 3200)

Human Plasma


794 NebivololLC-MS/MS (API 4000)

Human Plasma


795 Nevirapine HPLC-UVHuman Plasma

100 to 4000 ng / mL

CPD 200 mg

796 *NiacinLC-MS/MS



797 *NiacinLC-MS/MS



*NiacinLC-MS/MS



*Nicotinuric acidLC-MS/MS



799 NicorandilLC-MS/MS (API 3200)

Human Plasma


800 NifedipineLC-MS/MS (API 2000)

Human Plasma


801 NimodipineLC-MS/MS (Thermo)

Human Plasma


802 NintedanibLC-MS/MS



803 *NitrazepamLC-MS/MS (API 3200)

Human Plasma


804 Nitrofurantoin LC-MS/MS (Thermo)

Human Plasma


805 Nitrofurantoin LC-MS/MS(API 6500)

Human Plasma


*NitroglycerinLC-MS/MS(Shimadzu

8060)

Human Plasma

20 to 4000 pg/mL K2EDTA0.6mg sublingual

tablet fasting condition

1,3-di NitroglycerinLC-MS/MS(Shimadzu

8060)

Human Plasma



1,2-di NitroglycerinLC-MS/MS(Shimadzu

8060)

Human Plasma



787

791

792

798

806

I N D

I A

Page 45 of 73


Modified Method


Sr. No.

807 Nizatidine HPLC-UVHuman Plasma


300 mg

808 Nomegestrol AcetateLC-MS/MS



809 19-NorethindroneLC-MS/MS (API 4000)

Human Plasma


810 19-NorethindroneLC-MS/MS (Thermo)

Human Plasma


811 19-NorethindroneLC-MS/MS (Thermo)

Human Plasma

50 to 15000 pg / mL K2EDTA 0.35 mg

812 NortriptylineLC-MS/MS (Thermo)

Human Plasma


813 NortriptylineLC-MS/MS



814 OlanzapineLC-MS/MS (API 3000)

Human Plasma



Human Plasma


HydrochlorthiazideLC-MS/MS (API 3000)

Human Plasma

2.01 to 512.46 ng / mL

K2EDTA 25 mg

816 OmeprazoleLC-MS/MS (API 3000)

Human Plasma


-

817 OmeprazoleLC-MS/MS (Thermo)

Human Plasma


818 OmeprazoleLC-MS/MS (Thermo)

Human Plasma


819 OndansetronLC-MS/MS (API 3000)

Human Plasma


8 mg

820 OxcarbazepineLC-MS/MS (API 3000)

Human Plasma

0.01 to 10 µg / mL K2EDTA 300 mg/5 mL

82110,11-dihydro-10-Hydroxycarbamazepine

LC-MS/MS (API 3000)

Human Plasma

0.05 to 51.2 µg / mL K2EDTA -

OxcarbazepineLC-MS/MS (Thermo)

Human Plasma

0.01 to 5.12 µg / mL K2EDTA 300 mg/5 mL

10,11-dihydro-10-Hydroxycarbamazepine

LC-MS/MS (Thermo)

Human Plasma

0.05 to 25.6 µg / mL K2EDTA -

823 OxycodoneLC-MS/MS (Thermo)

Human Plasma


824 OxycodoneLC-MS/MS (Thermo)

Human Plasma



Human Plasma


OxymorphoneLC-MS/MS (API 3000)

Human Plasma


OxycodoneLC-MS/MS (Thermo)

Human Plasma


OxymorphoneLC-MS/MS (Thermo)

Human Plasma

0.234 to 60 ng / mL K2EDTA -


Human Plasma


NoroxycodoneLC-MS/MS (API 3000)

Human Plasma


OxymorphoneLC-MS/MS (API 3000)

Human Plasma

0.1 to 51.2 ng / mL K3EDTA -

CAN

ADA

I N D

I A

OLocation : Canada

815

822

825

826

827

Page 46 of 73


Modified Method


Sr. No.

OxybutyninLC-MS/MS



DesethyloxybutyninLC-MS/MS




Human Plasma


Hydroxy OxymorphoneLC-MS/MS (Thermo)

Human Plasma



Human Plasma



Human Plasma



Human Plasma

0.025 to 8.000 ng/mL

K2EDTA 20 mg


Human Plasma

0.025 to 8.000 ng/mL

K2EDTA 20 mg

832 *Orlistate (Fat analysis) FT-IR

HumanFecal/

HumanFood

0.25 to 10 g % NA60 mg / 120 mg

Oglimilast (GRC 3886)LC-MS/MS (API 4000)

Human Plasma


Oglimilat N-Oxide (GRC 3886 N-Oxide)

LC-MS/MS (API 4000)

Human Plasma


834 OlanzapineLC-MS/MS



5 mg

835 OlanzapineLC-MS/MS



836 OlmesartanLC-MS/MS (API 3200)

Human Plasma

2.5 to 1500 ng / mL

K2EDTA 20 mg


Human Plasma



Human Plasma


839 OmeprazoleLC-MS/MS



840 OmeprazoleLC-MS/MS



841 Omeprazole LC-MS/MS




Human Plasma

2 to 2200 ng/ml K2EDTA 20 mg


Human Plasma

2 to 2200 ng/mL K2EDTA 20 mg (without buffer)

844 Ondansetron LC-MS/MS



845 OndansetronLC-MS/MS



846O-Desmethyl Venlafaxine


Human Plasma


CAN

ADA

I N D

I A

Location : India

829

830

831

833

828

Page 47 of 73


Modified Method


Sr. No.

847O-Desmethyl Venlafaxine


Human Plasma


848 Ospemifene LC-MS/MS

(Waters QPXE)Human Serum

3 to 2400 ng / mL NA 60 mg

849 *OxazepamLC-MS/MS



Oxcarbazepine LC-MS/MS (API 3200)

Human Plasma


10,11-dihydro-10-hydroxycarbamazepine

LC-MS/MS (API 3200)

Human Plasma

50 to 16000 ng / mL

K2EDTA -

851 *Oxybutynin (S & R)LC-MS/MS (API 4000)

Human Plasma


OxybutyninLC-MS/MS



N-Desethyl OxybutyninLC-MS/MS



Oxybutynin LC-MS/MS (Waters QPXE)

Human Plasma

0.2 to 70 ng/mL K2EDTA 2x5mg


(Waters QPXE)Human Plasma 0.6 to 225 ng/mL

K2EDTA 2x5mg

OxybutyninLC-MS/MS






855 PantoprazoleLC-MS/MS (API 3000)

Human Plasma


856 Paroxetine HPLC - FlurosenceHuman Plasma


-

857 Paroxetine HPLC - FlurosenceHuman Plasma


-

858 Pentoxifylline HPLC-UVHuman Plasma


859 PergolideLC-MS/MS (API 3000)

Human Plasma

0.2 to 1.28 ng / mL Heparin -

860 Phenylephrine (Total)LC-MS/MS (Thermo)

Human Plasma


861 Phenytoin HPLC-UVHuman Plasma

0.04 to 2.56 µg / mL K3EDTA -

Phytonadione- TransLC-MS/MS (API 6500)

Human Plasma


Phytonadione- CisLC-MS/MS (API 6500)

Human Plasma


Phytonadione- TransLC-MS/MS (API 6500)

Human Plasma


Phytonadione- CisLC-MS/MS (API 6500)

Human Plasma


864 PomalidomideLC-MS/MS (API 6500)

Human Plasma


4 mg

I N D

I A

C A

N A

D A

862

863

Location : Canada

850

852

854

P

853

Page 48 of 73


Modified Method


Sr. No.

865 PramipexoleLC-MS/MS (Thermo)

Human Plasma


866*Prasugrel active metabolite (R-138727)

LC-MS/MS (Thermo)

Human Plasma

0.2 to 150 ng / mL K2EDTA 10 mg of Prasugrel

867*Prasugrel inactive metabolite (R-95913)

LC-MS/MS (Thermo)

Human Plasma


PravastatinLC-MS/MS (API 3000)

Human Plasma


-

3-α-Hydroxy PravastatinLC-MS/MS (API 3000)

Human Plasma


-

PravastatinLC-MS/MS (API 3000)

Human Plasma


80 mg

3-α-Hydroxy PravastatinLC-MS/MS (API 3000)

Human Plasma


-

PravastatinLC-MS/MS (Thermo)

Human Plasma


80 mg

3-α-Hydroxy PravastatinLC-MS/MS (Thermo)

Human Plasma


-

Primidone LC-MS/MS (API 3000)

Human Plasma


PhenobarbitalLC-MS/MS (API 3000)

Human Plasma


PhenylethylmalonamideLC-MS/MS (API 3000)

Human Plasma


872 ProgesteroneLC-MS/MS (API 6500)

Human Plasma


873 PseudoephedrineLC-MS/MS(API 6500)

Human Plasma

1 to 400 ng/mL Sodium Heparin 30mg

874 Paclitaxel (Total)LC-MS/MS



875 Paclitaxel (Total)LC-MS/MS

(Waters QPXE)

HumanWholeBlood

50 to 30000 ng / mL Heparin 220 mg / m2 (IV)

876 *Paclitaxel (Free)LC-MS/MS


5 to 2000 ng / mL Heparin 220 mg / m2 (IV)

877 Paclitaxel (Total)LC-MS/MS (API 6500)

Cynomolgus Monkey Plasma

25 to 25000ng / mL K2EDTA 100 mg

878 Paclitaxel (Free)LC-MS/MS (API 6500)

Cynomolgus Monkey Plasma

10 to 5000 ng / mL K2EDTA 21.7 (mg/kg)

879 Paclitaxel (Total)LC-MS/MS (API 6500)

Cynomolgus Monkey Blood

25 to 25000 ng / mL K2EDTA -

880 *ParicalcitolLC-MS/MS

(Waters XEVO TQ-S)Wistar

Rat Plasma50 to 30500 pg / mL

Sodium heparin

Multiple dose

881 Palbociclib LC-MS/MS



882 PaliperidoneLC-MS/MS (API 3200)

Human Plasma


C A

N A

D A

Location : India

869

870

871

I N D

I A

868

Page 49 of 73


Modified Method


Sr. No.

883 ParacetamolLC-MS/MS (API 3200)

Human Plasma

50 to 10000 ng / mL

K2EDTA 300 mg / 500 mg

884 ParacetamolLC-MS/MS



885 ParacetamolLC-MS/MS


50 to 24000 ng/mL K2EDTA 665x2 mg

886 ParoxetineLC-MS/MS (API 6500)

Human Plasma


887 ParoxetineLC-MS/MS (API 4000)

Human Plasma


888 PantoprazoleLC-MS/MS (API 3200)

Human Plasma


889 PazopanibLC-MS/MS


0.1 to 50 µg / mL K2EDTA 200/400 mg

890 PenciclovirLC-MS/MS (API 4000)

Human Plasma


891 Penicillin V HPLC-UVHuman Plasma


892 PerampanelLC-MS/MS



893 PerphenazineLC-MS/MS



894 PhenytoinLC-MS/MS (API 3200)

Human Plasma

10 to 10000 ng / mL K2EDTA 300mg (3X100mg)

895 Phenyl butyrate LC-MS/MS (API 3200)

Human Plasma


*Phytonadione (Vitamin K1) (Trans)

LC-MS/MS (Waters XEVO TQ-S)

Human Plasma


*Phytonadione (Vitamin K1) (Cis)

LC-MS/MS (Waters XEVO TQ-S)

Human Plasma



LC-MS/MS (API 6500)

UV light exposed human plasma, Human Plasma

0.4 to 100 ng / mL K2EDTA 5 mg fasting


LC-MS/MS (API 6500)

UV light exposed human plasma,

Human Plasma

0.3 to 25 ng / mL K2EDTA 5 mg fasting


LC-MS/MS (API 6500)

Human Plasma

1 to 500 ng / mL K2EDTA 5 mg (fed study)


LC-MS/MS (API 6500)

Human Plasma

1 to 100 ng / mL K2EDTA 5 mg (fed study)

*Pilocarpine LC-MS/MS



*Pilocarpic Acid LC-MS/MS



900 PioglitazoneLC-MS/MS (API 2000)

Human Plasma


901 PioglitazoneLC-MS/MS



899

896

898

897

I N D

I A

Page 50 of 73


Modified Method


Sr. No.

Pioglitazone LC-MS/MS


5 to 2800 ng / mL Sodium Heparin 45 mg

Hydroxy PioglitazoneLC-MS/MS


2 to 1500 ng / mL Sodium Heparin -

PioglitazoneLC-MS/MS



Keto PioglitazoneLC-MS/MS



Hydroxy PioglitazoneLC-MS/MS



MetforminLC-MS/MS



904 PirfenidoneLC-MS/MS (Thermo)

Human Plasma

50 to 20000 ng / mL K2EDTA 3 X 267 mg

905 PirfenidoneLC-MS/MS (Thermo)

Human Plasma

50 to 30000 ng / mL K2EDTA 3 X 267 mg

906 PirfenidoneLC-MS/MS(Shimadzu

8060)

Human Plasma

50 to 30000 ng / mL K2EDTA 801 mg

907 PirfenidoneLC-MS/MS



908 PiroxicamLC-MS/MS



909 Potassium Chloride Vitros 5.1,FSHuman Urine

2.041 to 150.358 mEq/L

NA 80mEq

910Potassium Citrate (Analyte - Potassium )

Vitros 5.1,FSHuman Urine

2 to 150 mmol/L NA60 mEq (4 X 15

mEq)

911 PomalidomideLC-MS/MS



912 PramipexoleLC-MS/MS


10 to 1000 pg / mL K2EDTA 0.25 mg



Human Plasma



LC-MS/MS (API 4000)

Human Plasma



LC-MS/MS (Thermo)

Human Plasma

0.2 to 150 ng/mL K2EDTA 10 mg of Prasugrel



Human Plasma



LC-MS/MS (API 4000)

Human Plasma


Pravastatin LC-MS/MS


2 to 600 ng / mL K2EDTA 40 mg/ 80 mg

3-α-Hydroxy PravastatinLC-MS/MS



Pravastatin LC-MS/MS



3-α-Hydroxy PravastatinLC-MS/MS



920 PravastatinLC-MS/MS



902

903

918

I N D

I A

919

Page 51 of 73


Modified Method


Sr. No.

921 PraziquantelLC-MS/MS



922 PrednisoloneLC-MS/MS (API 3200)

Human Plasma


923 PrednisoloneLC-MS/MS



924 PregabalinLC-MS/MS


50 to 15000 ng / mL K2EDTA 300 mg










928 Prochlorperazine LC-MS/MS (API 4000)

Human Plasma


929 ProchlorperazineLC-MS/MS



3 mg

930 prochlorperazineLC-MS/MS



3 mg (buccal tablet)

931 *ProgesteroneLC-MS/MS (Thermo)

Human Plasma

0.04 to 40 ng / mL K2EDTA 200 mg (fasting)

932 *ProgesteroneLC-MS/MS


0.15 to 150 ng / mL K2EDTA 200 mg (fed)

933 *ProgesteroneLC-MS/MS (Thermo)

Human Plasma

25 to 15000 pg / mL K2EDTA 100 mg

934 ProguanilLC-MS/MS



935 PromazineLC-MS/MS (API 4000)

Human Plasma

0.1 to 50 ng/mL K2EDTA 50mg/5mL

936 PromethazineLC-MS/MS (API 4000)

Human Plasma


Propafenone LC-MS/MS



5-Hydroxy Propafenone LC-MS/MS



938 PropafenoneLC-MS/MS



939 S-Propanolol (Total)LC-MS/MS (API 3200)

Human Plasma


940 PropylthiouracilLC-MS/MS



941 PseudoephedrineLC-MS/MS (API 3200)

Human Plasma

2 to 400 ng /mL Heparin 30 mg

942 PyrazinamideLC-MS/MS



943 PyridostigmineLC-MS/MS

(Waters QPXE)

Human Plasma containing 1M

Sodium Fluoride (10%)

0.4 to 100 ng/mL K2EDTA 60mg Yes

937

I N D

I A

Page 52 of 73


Modified Method


Sr. No.

944 2-Pyridylacetic acid LC-MS/MS


5 to 800 ng / mL K2EDTA 16 mg of Betahistine

945 2-Pyridyl acetic acidLC-MS/MS (Thermo)

5% Selegiline buffered

Human Plasma10 to 1500 ng/mL K2EDTA 24 mg

946 QuetiapineLC-MS/MS (Thermo)

Human Plasma


947 QuetiapineLC-MS/MS



Quetiapine LC-MS/MS



N-desalkyl Quetiapine LC-MS/MS



QuetiapineLC-MS/MS (API 2000)

Human Plasma


N-desalkyl Quetiapine LC-MS/MS (API 2000)

Human Plasma




0.5 to 350 ng / mL Heparin 25 mg / 50 mg

951 QuetiapineLC-MS/MS (API 2000)

Human Plasma


Quetiapine LC-MS/MS (API 2000)

Human Plasma


N-Des Alkylated QuetiapineLC-MS/MS (API 2000)

Human Plasma





150 mg / 200 mg




QuetiapineLC-MS/MS (API 2000)

Human Plasma

20 to 2000 ng / mL K2EDTA 300 /400 mg

N-Des Alkylated QuetiapineLC-MS/MS (API 2000)

Human Plasma



Human Plasma


300 /400 mg




25 mg


Human Plasma


100 mg

959 QuinaprilLC-MS/MS



960 QuinineLC-MS/MS



948

949

952

955

Q

C A

N A

D A

Location : India

I N D

I A

I N D

I A

Location : Canada

Page 53 of 73


Modified Method


Sr. No.

961 RabeprazoleLC-MS/MS (API 3000)

Human Plasma


RamiprilLC-MS/MS (API 3000)

Human Plasma


RamiprilatLC-MS/MS (API 3000)

Human Plasma


RamiprilLC-MS/MS (Thermo)

Human Plasma


RamiprilatLC-MS/MS (Thermo)

Human Plasma



Human Plasma



Human Plasma


RamiprilLC-MS/MS (Thermo)

Human Plasma


RamiprilatLC-MS/MS (Thermo)

Human Plasma


966 RanitidineLC-MS/MS (Thermo)

Human Plasma


Rifabutin LC-MS (API 150)Human Plasma


25-O-Desacetylrifabutin LC-MS (API 150)Human Plasma


Clofazimine LC-MS (API 150)Human Plasma


968 RisedronateLC-MS/MS (Thermo)

Human Plasma


969 RisedronateLC-MS/MS (Thermo)

Human Plasma


970 RivastigmineLC-MS/MS (Thermo)

Human Plasma

0.3 to 63 ng / mL K2EDTA Transdermal Patch 9.5 mg

971 RivastigmineLC-MS/MS (API 6500)

Human Plasma

0.3 to 63 ng / mL K2EDTA 9.5 mg yes

972 RosiglitazoneLC-MS/MS (API 3000)

Human Plasma


8 mg

973 RosuvastatinLC-MS/MS (Thermo)

Human Plasma



Human Plasma



Human Plasma

5 to 1000 ng / mL K3EDTA/ Heparin 20 mg


Human Plasma

2 to 1200 ng / mL K2EDTA 10 / 20 mg


Human Plasma

2 to 1200 ng / mL K2EDTA 10 / 20 mg

Location : India

R

Location : Canada

962

963

964

965

967

I N D

I A

C A

N A

D A

Page 54 of 73


Modified Method


Sr. No.

*RaloxifeneLC-MS/MS (Thermo)

Human Plasma


*Raloxifene 4-glucuronideLC-MS/MS (Thermo)

Human Plasma



Human Plasma

0.35 to 100 ng / mL K2EDTA -

*RaloxifeneLC-MS/MS (Thermo)

Human Plasma



Human Plasma



Human Plasma



Human Plasma


10 mg


Human Plasma


-

981 *Ramipril LC-MS/MS (API 3200)

Human Plasma


982 *Ramipril LC-MS/MS (API 3200)

Human Plasma

0.05 to 40 ng / mL Heparin2.5 mg /

5 mg

983 RamiprilLC-MS/MS (API 3200)

Human Plasma


10mg

984 RanolazineLC-MS/MS









987 RanitidineLC-MS/MS (API 2000)

Human Plasma

10 to 2000 ng / mL Heparin150 /

300 mg

988 Ranitidine HPLC-UVHuman Plasma


300 mg

989 Ranitidine LC-MS/MS (API 2000)

Human Plasma


75 mg

990 RasagilineLC-MS/MS


40 to 14000 pg / mL K2EDTA 1 mg (Fasting study)

991 RasagilineLC-MS/MS


40 to 6000 pg/mL K2EDTA 1 mg ( Fed study)

992 RepaglinideLC-MS/MS (API 3200)

Human Plasma


RifampicinLC-MS/MS (API 4000)

Human Plasma

200 to 15000ng / mL K2EDTA 150mg

Desacetyl RifampicinLC-MS/MS (API 4000)

Human Plasma

10 to 2000ng / mL K2EDTA 150mg

Rifampicin LC-MS/MS (API 4000)

Human Plasma

75 to 15000 ng /mL K2EDTA 150mg/300mg

25 Desacetyl RifampicinLC-MS/MS (API 4000)

Human Plasma

10 to 4000 ng /mL K2EDTA NA

995 RifaximinLC-MS/MS (Thermo)

Human Plasma

25 to 15000 pg / mL

K2EDTA 550 mg


Human Plasma

0.05 to 100 ng / mL K2EDTA 550 mg

997 RifaximinLC-MS/MS (API 6500)

Human Plasma


978

979

980

993

994

I N D

I A

Page 55 of 73


Modified Method


Sr. No.


Human Plasma



Human Plasma


1000 RilpivirineLC-MS/MS



1001 RivaroxabanLC-MS/MS








1 to 600 ng/mL K2EDTA 10 mg / 20 mg

1004 *Risedronate LC-MS/MS (Thermo)

Human Plasma


1005 *RisedronateLC-MS/MS



35 mg


Human Plasma



Human Plasma


Risperidone LC-MS/MS (API 4000)

Human Plasma


9- hydroxy RisperidoneLC-MS/MS (API 4000)

Human Plasma


1009 RizatriptanLC-MS/MS



1010 RupatadineLC-MS/MS (API 3200)

Human Plasma


1011 RopiniroleLC-MS/MS (API 3200)

Human Plasma


1012 RopiniroleLC-MS/MS (API 4000)

Human Plasma

10 to 3000 pg / mL K2EDTA 0.25 mg

1013 Rosiglitazone LC-MS/MS (API 2000)

Human Plasma


1014 Rosiglitazone LC-MS/MS (API 2000)

Human Plasma



Human Plasma



Human Plasma


1017 RosuvastatinLC-MS/MS



1018 RoxithromycinLC-MS/MS(Shimadzu

8045)

Human Plasma

0.05 to 25 μg/mL K2EDTA 150 mg

I N D

I A

1008

Page 56 of 73


Modified Method


Sr. No.

1019 ScopolamineLC-MS/MS (API 6500)

Human Plasma

1 to 400 pg/mL K2EDTA 1 mg Patch

SertralineLC-MS/MS (API 3000)

Human Plasma


100 mg

N-DesmethylsertralineLC-MS/MS (API 3000)

Human Plasma


-

Sildenafil LC-MS/MS (API 6500)

Human Plasma

1 to 500 ng/mL K2EDTA 10 mg/mL

N-Desmethyl SildenafilLC-MS/MS (API 6500)

Human Plasma


SimvastatinLC-MS/MS



-

Simvastatin Hydroxy Acid

LC-MS/MS (API 300 or 3000)

Human Plasma


-

SimvastatinLC-MS/MS(Thermo)

Human Plasma

0.1 to 51.2 ng / mL K2EDTA 80 mg

Simvastatin Hydroxy Acid

LC-MS/MS(Thermo)

Human Plasma

0.1 to 25.6 ng / mL K2EDTA -

1024 SirolimusLC-MS/MS (API 3000)

Human WholeBlood


1025 SitagliptinLC-MS/MS(Thermo)

Human Plasma


1026 SotalolHPLC


10 to 2560 ng / mL heparin -

Sulfamethoxazole HPLC-UVHuman Plasma


Trimethoprim HPLC-UVHuman Plasma

0.02 to 2.56 µg / mL K3EDTA 50 mg

SufentanilLC-MS/MS (Thermo)

Human Plasma

0.01 to 1.28 ng / mL K2EDTA -

TriazolamLC-MS/MS (Thermo)

Human Plasma

0.1 to 12.8 ng / mL K2EDTA -

SufentanilLC-MS/MS (Thermo)

Human Plasma


TriazolamLC-MS/MS (Thermo)

Human Plasma

0.05 to 6.4 ng / mL K2EDTA 200 mcg

SulfasalazineLC-MS



SulfapyridineLC-MS


200 to 25600 ng / mL K3EDTA -

5-Aminosalicylic AcidLC-MS



Acetyl-5-Aminosalicylic AcidLC-MS



1031 Sumatriptan LC-MS/MS (Thermo)

Human Plasma


1032 Sumatriptan LC-MS/MS

(API 300 or 3000)

HumanPlasmaor Pig

Plasma


C A

N A

D A

1027

1028

1029

1030

S

Location : Canada

1022

1023

1020

1021 Yes

Page 57 of 73


Modified Method


Sr. No.

1033 *SalmeterolLC-MS/MS



1034 SecnidazoleLC-MS/MS (API 3200)

Human Plasma


1035 SertralineLC-MS/MS (API 3200)

Human Plasma

1 to 100 ng / mL Sodium Heparin 100 mg

1036 SertralineLC-MS/MS



SibutramineLC-MS/MS


100 to 20000 pg / mL

Heparin / K2EDTA 15 mg

Desmethyl SibutramineLC-MS/MS


50 to 10800 pg / mL

Heparin / K2EDTA -

Didesmethyl SibutramineLC-MS/MS


75 to 15000 pg / mL

Heparin / K2EDTA -


Human Plasma


Desmethyl SildenafilLC-MS/MS (API 3200)

Human Plasma



Human Plasma


Desmethyl SildenafilLC-MS/MS (API 3200)

Human Plasma


Simvastatin LC-MS/MS (API 4000)

Human Plasma


Simvastatin acidLC-MS/MS (API 4000)

Human Plasma


Simvastatin LC-MS/MS (API 4000)

Human Plasma


Simvastatin acidLC-MS/MS (API 4000)

Human Plasma


1042 SimvastatinLC-MS/MS(Thermo)

Human Plasma


10 mg

1043 SirolimusLC-MS/MS



1044 SirolimusLC-MS/MS

(Waters XEVO TQ-S)HumanBlood

40 to 12000 pg / mL K2EDTA 0.5 mg

1045 SitagliptinLC-MS/MS (API 4000)

Human Plasma


100mg/50mg

1046 SitagliptinLC-MS/MS (API 4000)

Human Plasma

2 to 1200 ng / mLSodium Heparin

100mg

1047 SofosbuvirLC-MS/MS (API 4000)

Human Plasma


1048 SolifenacinLC-MS/MS (Thermo)

Human Plasma


1049 SolifenacinLC-MS/MS (API 4000)

Human Plasma


1050 SorafenibLC-MS/MS



SpironolactoneLC-MS/MS (API 3200)

Human Plasma


Canrenone LC-MS/MS (API 3200)

Human Plasma


I N D

I A

1051

1037

1038

1039

1040

1041

Location : India

Page 58 of 73


Modified Method


Sr. No.

1052 Spironolactone LC-MS/MS (API 4000)

Human Plasma


1053 SpironolactoneLC-MS/MS



SulfamethoxazoleLC-MS/MS


100 to 90000 ng / mL

K2EDTA 800 mg

TrimethoprimLC-MS/MS



1055 Sumatriptan LC-MS/MS (API 2000)

Human Plasma


1056 SunitinibLC-MS/MS (API 4000)

Human Plasma


12.5 mg

1057 SunitinibLC-MS/MS (API 3200)

Human Plasma


50mg

1058 TacrolimusLC-MS/MS(Thermo)

Human WholeBlood

0.2 to 25 ng / mL K2EDTA 0.5 to 4 mg

1059 TamoxifenLC-MS/MS (API 3000)

Human Plasma


TamoxifenLC-MS



N-DesmethyltamoxifenLC-MS



1061 TamsulosinLC-MS/MS(Thermo)

Human Plasma


1062 TemazepamLC-MS/MS (API 3000)

Human Plasma


1063 TerazosinHPLC



1064 Terbinafine HPLC-UVHuman Plasma

0.01 to 2.5 µg / mL K3EDTA 250 mg

1065 TestosteroneLC-MS/MS


0.1 to 25 ng / mL K2EDTA 1% gel

TetrabenazineLC-MS/MS (Thermo)

Human Plasma

0.015 to 3.84 ng / mL K2EDTA 50 mg

α-DihydrotetrabenazineLC-MS/MS (Thermo)

Human Plasma

0.625 to 160 ng / mL K2EDTA -

β-Dihydrotetrabenazine LC-MS/MS (Thermo)

Human Plasma

0.469 to 120 ng / mL K2EDTA -

1067 TetracyclineLC-MS/MS (Thermo)

Human Plasma

200 to 20000 ng / mL K2EDTA 500 mg

1068 Theophylline HPLC-UVHuman Plasma


TicagrelorLC-MS/MS (Thermo)

Human Plasma


Deshydroxyethoxy TicagrelorLC-MS/MS (Thermo)

Human Plasma


1070 Ticlopidine HPLC-UVHuman Plasma


1071 TofacitinibLC-MS/MS (Thermo)

Human Plasma

0.2 to 100 ng/mL K2EDTA 11 mg and 5 mg

C A

N A

D A

I N D

I A

1069

1054

T

Location : Canada

1060

1066

Page 59 of 73


Modified Method


Sr. No.

1072 TopiramateLC-MS/MS (API 3000)

Human Plasmaor DogPlasma


50 mg


Human Plasma


200 mg

1074 TorsemideLC-MS/MS


10 to 10240 ng / mL K3EDTA -

TramadolHPLC



O-DesmethyltramadolHPLC



1076 TramadolLC-MS/MS (API 3000)

HumanPlasma

orMousePlasma


O-DesmethyltramadolLC-MS/MS (API 3000)

HumanPlasma

orMousePlasma


O,N-di-DesmethyltramadolLC-MS/MS (API 3000)

HumanPlasma

orMousePlasma


TramadolLC-MS/MS (API 3000)

Human Urine


applicable-


Human Urine

0.05 to 12.5 µg / mLNot

applicable-

O,N-di-Desmethyltramadol

LC-MS/MS (API 3000)

Human Urine

0.05 to 12.5 µg / mLNot

applicable-

TramadolLC-MS/MS (API 3000)

Dog Plasma



Dog Plasma


TramadolLC-MS/MS(Thermo)

Human Plasma


O-DesmethyltramadolLC-MS/MS(Thermo)

Human Plasma


O,N-di-Desmethyltramadol

LC-MS/MS(Thermo)

Human Plasma


MeloxicamLC-MS/MS(Thermo)

Human Plasma

3.75 to 1920 ng / mL K2EDTA -

1081 TramadolLC-MS/MS (Thermo)

Human Plasma


1082 TramadolLC-MS/MS (Thermo)

Human Plasma


1083 TrazodoneHPLC



1084Triamcinolone acetonide

LC-MS/MS(Thermo)

Human Plasma

0.025 to 6.4 ng/mL K2EDTA 10 mg/mL

TrimebutineLC-MS/MS(Thermo)

Human Plasma


N-DesmethyltrimbutineLC-MS/MS(Thermo)

Human Plasma


C A

N A

D A

1075

1077

1078

1079

1080

1085

Page 60 of 73


Modified Method


Sr. No.

1086 TacrolimusLC-MS/MS(Thermo)

HumanWholeBlood

40 to 12000 pg / mL

K2EDTA 0.5 mg

1087 TacrolimusLC-MS/MS


40 to 12000 pg / mL K2EDTA 0.5 mg / 1 mg

1088 TacrolimusLC-MS/MS



1089 *TacrolimusLC-MS/MS

(Shimadzu 8060)HumanBlood

5 to 500 pg / mL K2EDTA 0.1 % gel

1090 TacrolimusLC-MS/MS (Thermo)

Human Blood


1091 TadalafilLC-MS/MS












1095 TamsulosinLC-MS/MS



Tamoxifen LC-MS/MS (API 3200)

Human Plasma


Endoxifen LC-MS/MS (API 3200)

Human Plasma


1097 TapentadolLC-MS/MS



1098 TapentadolLC-MS/MS



1099*Teicoplanin components (A2-1, A2-2, A2-3, A2-4, and A2-5)


Human Plasma

2 to 250 µg/ mL K2EDTA 400 mg injection

1100*Teicoplanin component (A 3)


Human Plasma

2 to 250 µg/ mL K2EDTA 400 mg injection

1101 TelmisartanLC-MS/MS



1102 *TemozolomideLC-MS/MS


100 to 20000 ng / mL

Heparin 250 mg

1103*Temozolomide Metabolite (MTIC)


Human Plasma

3 to 600 ng /mL Heparin250 mg of

Temozolamide

1104 Teneligliptin LC-MS/MS


10 to 800 ng/mL K2EDTA 2X20 mg

1105 TenofovirLC-MS/MS



1106 TenofovirLC-MS/MS

(Waters QPXE)HumanSerum

3 to 800 ng / mL NA 245 mg

1107 TenofovirLC-MS/MS (API 4000)

Human Plasma


1108 TenofovirLC-MS/MS (Thermo)

Human Plasma


I N D

I A

Location : India

1096

Page 61 of 73


Modified Method


Sr. No.

1109 Tenofovir Alafenamide LC-MS/MS



1110 Tenoxicam HPLC-UVHuman Plasma


20 mg

1111 Tenoxicam HPLC-UVHuman Plasma


20 mg

1112 *Tetranor-PGEM LC-MS/MS (API 4000)

Human Urine

1 to 50 ng / mL NA NA

1113 Terbinafine LC-MS/MS (API 2000)

Human Plasma


1114 TeriflunomideLC-MS/MS



1115 Testosterone LC-MS/MS



TetrabenazineLC-MS/MS (API 6500)

Human Plasma


dihydro TetrabenazineLC-MS/MS (API 6500)

Human Plasma


Tetrabenazine LC-MS/MS (API 6500)

Human Plasma


DihdroxyTetrabenazineLC-MS/MS (API 6500)

Human Plasma


1118 Thalidomide (R & S)LC-MS/MS



1119 TheophyllineLC-MS/MS


50 to 20000 ng/mL K2EDTA 400 ER capsule Fast/Fed

1120 ThiorphanLC-MS/MS


1 to 160 ng / mL K2EDTA 30 mg of Racecadotril

1121 *Thromboxane B2LC-MS/MS

(Shimadzu 8040)HumanUrine

0.2 to 20 ng / mL Not applicable NA

TicagrelorLC-MS/MS



Deshydroxyethoxy ticagrelorLC-MS/MS



1123 TinidazoleLC-MS/MS



1124 TofacitinibLC-MS/MS (API 4000)

Human Plasma


1125 TolterodineLC-MS/MS



4mg




4 mg




4 mg (steady state)

TolterodineLC-MS/MS



5-Hydroxymethyl tolterodine


Human Plasma

20 to 10000 pg / mL

Heparin -

I N D

I A

1122

1128

1116

1117

Page 62 of 73


Modified Method


Sr. No.

TolterodineLC-MS/MS (API 4000)

Human Plasma

20 to 7500 pg / mL Heparin 2mg

5-hydroxymethyl Tolterodine

LC-MS/MS (API 4000)

Human Plasma

10 to 7520 pg / mL Heparin -

Tolterodine LC-MS/MS



5-hydroxymethyl Tolterodine


Human Plasma

10 to 5000 pg / mL Heparin -

1131 TolvaptanLC-MS/MS




Human Plasma

50 to 4000 ng / mL Heparin 50 / 100 mg


Human Plasma


1134 Topiramate LC-MS/MS (API 3200)

Human Plasma


200 mg

1135 TorsemideLC-MS/MS (API 3200)

Human Plasma


1136 TramadolLC-MS/MS


1 to 400 ng / mL Heparin 37.5 mg / 50 mg

TramadolLC-MS/MS



O-desmethyl tramadol LC-MS/MS



Trandolapril LC-MS/MS



TrandolaprilatLC-MS/MS



1139 TrazodoneLC-MS/MS (API 3200)

Human Plasma


1140 TrazodoneLC-MS/MS



1141 Triamcinolone Acetonide LC-MS/MS (API 6500)

Human Plasma

5 to 2500 pg / mL K2EDTA 40 mg / mL

1142 TrifluoperazineLC-MS/MS (API 2000)

Human Plasma

0.05 to 10 ng / mL CPD -

Trimebutine LC-MS/MS (API 3200)

Human Plasma


N-Desmethyl Trimebutine

LC-MS/MS (API 3200)

Human Plasma


1144 TrimetazidineLC-MS/MS



1145 TrimetazidineLC-MS/MS


0.4 to 250 ng / mL Heparin35 mg mutiple

dose

1146 Trimethoprim HPLC-UVHuman Plasma

0.025 to 2.5 µg / mL CPD 50 mg

1147 TrospiumLC-MS/MS (API 4000)

Human Plasma



Human Plasma



Human Plasma


37.5 mg / 50 mg

1138

1143

I N D

I A

1129

1130

1137

Page 63 of 73


Modified Method


Sr. No.

UrsodiolLC-MS


100 to 12800 ng / mL K3EDTA -

GlycoursodeoxycholicAcid

LC-MS (API 150)

Human Plasma

150 to 19200 ng / mL K3EDTA -

Tauroursodeoxycholic Acid

LC-MS (API 150)

Human Plasma

100 to 12800 ng / mL K3EDTA -

1151 ValsartanLC-MS/MS (API 3000)

Human Plasma

20 to 10240 ng / mL K2EDTA 160 mg

1152 ValsartanLC-MS/MS (Waters)

Human Plasma


VenlafaxineLC-MS/MS (API 3000)

Human Plasma


150 mg

O-Desmethylvenlafaxine

LC-MS/MS (API 3000)

Human Plasma


-

VenlafaxineLC-MS/MS (Thermo)

Human Plasma


300 mg

Orthodesmethyl Venlafaxine

LC-MS/MS (Thermo)

Human Plasma


-

VenlafaxineLC-MS/MS (API 3000)

Human Plasma


75 mg

O-Desmethylvenlafaxine

LC-MS/MS (API 3000)

Human Plasma


-

N-Desmethylvenlafaxine

LC-MS/MS (API 3000)

Human Plasma


-

N,O-Didesmethylvenlafaxine

LC-MS/MS (API 3000)

Human Plasma


-

N,N,O-Tridesmethylvenlafaxine

LC-MS/MS (API 3000)

Human Plasma


-

VenlafaxineLC-MS/MS

(API 300 or 3000)Human Urine


applicable-

O-DesmethylvenlafaxineLC-MS/MS



applicable-

N-DesmethylvenlafaxineLC-MS/MS



applicable-

N,O-Didesmethylvenlafaxine


Human Urine


applicable-

N,N,O-Tridesmethylvenlafaxine


Human Urine


applicable-

VerapamilHPLC



NorverapamilHPLC



VerapamilLC-MS/MS (Thermo)

Human Plasma


240 mg

NorverapamilLC-MS/MS (Thermo)

Human Plasma


-

1157

1158

C A

N A

D A

1150

V

Location : Canada

1153

1154

1155

1156

U

C A

N A

D A

Location : Canada

Page 64 of 73


Modified Method


Sr. No.

Verapamil (chiral)HPLC



Norverapamil (chiral)HPLC



1160 VigabatrinLC-MS



Valacyclovir LC-MS/MS (API 2000)

Human Plasma


AcyclovirLC-MS/MS (API 2000)

Human Plasma


Valacyclovir LC-MS/MS (API 2000)

Human Plasma


AcyclovirLC-MS/MS (API 2000)

Human Plasma


ValganciclovirLC-MS/MS (API 3200)

Human Plasma


GanciclovirLC-MS/MS (API 3200)

Human Plasma

25 to 10000 ng / mL K2EDTA -

ValganciclovirLC-MS/MS (API 3200)

Human Plasma


GanciclovirLC-MS/MS (API 3200)

Human Plasma


Valganciclovir LC-MS/MS



Ganciclovir LC-MS/MS


40 to 12000 ng / mL K2EDTA -

1166 valganciclovirLC-MS/MS (API 3200)

Human Plasma


1167 Valproic acid HPLC-UVHuman Plasma

1 to 110 µg / mL Heparin 500 mg

1168 Valproic acid LC-MS/MS


0.25 to 25 µg/mLSodium heparin

200mg Yes

1169 Valproic acid LC-MS/MS


1 to 80 µg / mLSodium heparin

500 mg

1170 ValsartanLC-MS/MS(API 3200)

Human Plasma



Human Plasma



Human Plasma


1173 ValsartanLC-MS/MS(API 3200)

Human Plasma


320 mg


Human Plasma

50 to 20000 ng / mL K2EDTA 320 mg

ValsartanLC-MS/MS(Thermo)

Human Plasma

50 to 20000 ng / mL K2EDTA 320 mg

HydrochlorothiazideLC-MS/MS(Thermo)

Human Plasma


1176 VenetoclaxLC-MS/MS


1 to 400 ng/mL K2EDTA 100 mg fasting

1175

1159

Location : India

1161

1162

1163

1164

1165

I N D

I A

C A

N A

D A

Page 65 of 73


Modified Method


Sr. No.


(Waters QPXE)Human Plasma 1 to 700 ng / mL K2EDTA 100 mg Fast



2.5 to 1500 ng/mL K2EDTA 100 mg Fed



4 to 2800 ng/mL K2EDTA 100 mg Fed

1180 VenlafaxineLC-MS/MS



150 mg

VenlafaxineLC-MS/MS


1 to 600 ng / mL Sodium Heparin 150 mg /225 mg

O-Desmethyl Venlafaxine LC-MS/MS


2 to 800 ng / mL Sodium Heparin -

VenlafaxineLC-MS/MS(Thermo)

Human Plasma


O-DesmethylvenlafaxineLC-MS/MS(Thermo)

Human Plasma


Verapamil HPLC



NorverapamilHPLC



Verapamil LC-MS/MS



Norverapamil LC-MS/MS



Verapamil LC-MS/MS



NorverapamilLC-MS/MS



Trandolapril LC-MS/MS



TrandolaprilatLC-MS/MS



1186 VardenafilLC-MS/MS



20 mg

1187 VilazodoneLC-MS/MS



1188 VilazodoneLC-MS/MS



1189 VildagliptinLC-MS/MS


1 to 500 ng/mLSodium Heparin

50 mg

1190 *Vitamin D3LC-MS/MS (Thermo)

Human Plasma

0.25 to 20 ng / mL K2EDTA 5600 IU / 2600 IU

1191 *Vitamin D3LC-MS/MS (Thermo)

Human Plasma

1 to 200 ng / mL K2EDTA 40000 IU

1192 VoriconazoleLC-MS/MS (API 3200)

Human Plasma


1193 VoriconazoleLC-MS/MS (API 3200)

Human Plasma

5 to 4000 ng / mL K2EDTA 40mg/mL or 200 mg

1185

I N D

I A

1181

1182

1183

1184

Page 66 of 73


Modified Method


Sr. No.

R-WarfarinLC-MS/MS (API 3000)

Human Plasma


S-WarfarinLC-MS/MS (API 3000)

Human Plasma


1195 WarfarinHPLC



1196 WarfarinHPLC



1197 Ziprasidone LC-MS/MS (API 3000)

Human Plasma


1198 Ziprasidone LC-MS/MS (API 3000)

Human Plasma


Zolmitriptan LC-MS/MS (Thermo)

Human Plasma

0.2 to 20 ng/mL K2EDTA 5mg Nasal spray

N-desmethyl ZolmitriptanLC-MS/MS (Thermo)

Human Plasma

0.1 to 10 ng/mL K2EDTA 5mg Nasal spray

1200 ZolpidemHPLC



1201 Ziprasidone HPLC


1.5 to 200 ng / mL NA 40 mg

Zolmitriptan LC-MS/MS



N-desmethyl ZolmitriptanLC-MS/MS



1203 ZolpidemLC-MS/MS (API 3200)

Human Plasma


1204 Zonisamide HPLC-UVHuman Serum

25 to 3000 ng / mL NA 100 mg

*: Premium method

Z

C A

N A

D A

I N D

I A

1202

W

C A

N A

D A Location : Canada

1194

Location : India

Location : Canada

Location : India

I N D

I A

1199

Page 67 of 73

Drug Name Instrument Matrix LLOQ Anticoagulant

New Chemical Entity - 1aLC-MS/MS (Thermo)

Rat Plasma or

Dog Plasma0.5 ng / mL Lithium heparin

New Chemical Entity - 1bLC-MS/MS (Thermo)

Rat Plasma or

Dog Plasma0.8 ng / mL Lithium heparin

2 New Chemical Entity - 2LC-MS/MS (Thermo)

Human Plasma

0.8 ng / mL Lithium heparin

3 New Chemical Entity - 3bLC-MS/MS (Thermo)

Dog cerebrospinal fluid

0.8 ng / mL Not applicable

New Chemical Entity - 4 (±)HPLC -

FlurosenceHuman Plasma 5 ng / mL K2EDTA

New Chemical Entity - 4a (±)HPLC -


New Chemical Entity - 4b (±)HPLC -



Human Plasma 2.94 ng/mL K2EDTA


Human Plasma 1.96 ng/mL Not applicable

7 New Chemical Entity-01LC-MS/MS (API 4000)

Human Plasma 5 ng / mL K2EDTA

New Chemical Entity-02LC-MS/MS (API 4000)

Human Plasma 0.5 ng / mL K2EDTA

N-Oxide of New Chemical Entity-02

LC-MS/MS (API 4000)

Human Plasma 0.5 ng / mL K2EDTA




Human Plasma 10 ng /mL K2EDTA


Human Plasma 1 ng /mL K2EDTA & K3EDTA

12 New Chemical Entity-06LC-MS/MS

(Waters QPXE)Monkey Plasma 50 ng / mL K2EDTA

New Chemical Entity-07aLC-MS/MS (API 4000)


New Chemical Entity-07bLC-MS/MS (API 4000)




15 *New Chemical Entity-09LC-MS/MS (Thermo)


16 *New Chemical Entity-10LC-MS/MS

(Waters XEVO TQ-S)



Human Plasma 0.2 to 100 ng / mL K2EDTA


13

8

Location : Canada

Location : India

1

4

C A

N A

D A

Sr. No.(FULL NAME WITHHELD DUE TO CONFIDENTIALITY)

NEW CHEMICAL ENTITIESI N

D I

A

Page 68 of 73 *: Premium Method

Sr. No. Drug Name Instrument Matrix Range Anticoagulant

1*Doxorubicin (Encapsulated andTotal) (Liposomal)

LC-MS/MS (Waters)

Human Plasma

2500 to 250000 ng / mL K2EDTA

2*Doxorubicin (Encapsulated andTotal) (Liposomal)


Human Plasma

0.5 to 25 µg / mL K2EDTA

3 *Doxorubicin (Free) (Liposomal)LC-MS/MS (Waters)

Human Plasma


4 *Doxorubicin (Free) (Liposomal)LC-MS/MS



IN-VITRO STUDIES

Location : India


Page 69 of 73

*: Premium Method

Sr. No. Molecules

1 Screening, Confirmatory assays for Antibodies against Darbepoetin (Bridging ELISA)

2 Neutralising assay for antibodies against Darbepoetin (Cell based Assay)

3 Screening, Confirmatory assays for Antibodies against Erythropoietin (Bridging ELISA)

4 Neutralising antibodies to Erythropoietin (Cell based Assay)

5 Screening, Confirmatory assays for Antibodies against Ranibizumab by (Bridging ELISA)

6Screening, Confirmatory assays for Antibodies against Rituximab (Affinity Capture and Elution basedELISA)

7 Screening, Confirmatory assays for Antibodies against Trastuzumab (Bridging ELISA)

8 Screening, Confirmatory assays for Antibodies against Denosumab (Bridging ELISA)

9 Screening, Confirmatory assays for Antibodies against Teriperatide (ELISA)

10 Screening, Confirmatory assays for Antibodies against PEG-GCSF (ECL-MSD)

11 Cell based assay for detection of neutralizing antibodies against PEG-GCSF

12 Screening, Confirmatory assays for Antibodies against GCSF (ECL-MSD)

13 Cell based assay for detection of neutralizing antibodies against GCSF

14 Screening, Confirmatory assays for Antibodies against Romiplostim (ELISA)

15 Cell based assay for detection of neutralizing antibodies against Teriperatide

16 Screening, Confirmatory assays for Antibodies against FSH (ELISA)

17 *Cell based assay for detection of neutralizing antibodies against FSH

18*Elisa based method for determination and characterization of neutralizing antibodies againstBevacizumab in normal human serum samples

19Elisa based method for Immunogenicity assessment of Bevacizumab in normal human serumsamples


IMMUNOGENICITY ASSESMENT

*: Developed method available

Page 70 of 73

Sr. No PD Markers/Surrogate PD markers

1 3 Beta-D- Glucan

2 Absolute Neutrophil Counts (ANC) (Flow Cytometry)

3 ACTH (Adrenocorticotropic hormone)

4 Anti-Factor IIa activity of Enoxaparin (Colorimetric Method)

5 Anti-Factor Xa activity of Enoxaparin (Colorimetric Method)

6 Anti-Factor IIa activity of Low molecular weight heparin (Colorimetric Method)

7 Anti-Factor Xa activity of Low molecular weight heparin (Colorimetric Method)

8 Apolipoprotein A1 (Immunoturbidimetric)

9 Apolipoprotein B

10 BAP- Bone specific Alkalinephosphatase (ELISA)

11 Basophil Activation Test (Flow Cytometery)

12 Beta 2 Microglobulin (ELISA)

13 Cluster of Differentiation 34 - CD 34 (Flow Cytometery)

14 Cluster of Differentiation 19 - CD19 (Flow Cytometery)

15 CMV-IgM (Cytomegalovirus Antibody)

16 C-peptide

17 Corrected serum Calcium

18 Cortisol(Serum)

19 Direct- LDL-C (photometric)

20 Ecarin Clotting Time for Bivaluridin (Clot Based Assay)

21 Erythropoetin (ELISA)

22 Estradiol

23 Ferritin

24 Free T3 & Free T4

25 Fructosamine

26 Glucose (Glucose Oxidase Peroxidase Method)

27 Glycosylated Haemoglobin

28 Hep Test (Clot Based Assay)

29 High Sensitivity C-Reactive Protein (hs-CRP)

30 Human Serum Adiponectin-HMW (ELISA)

31 Human Serum Adiponectin-Total (ELISA)

32 Human Serum/Plasma Glucagon

33 IL-6 (Interleukin-6)


PD MARKERS

Page 71 of 73

Sr. No PD Markers/Surrogate PD markers


PD MARKERS

34 Insulin

35 Lipoprotein (a)

36 NEFA/FFA (Non Esterified Fatty Acids/Free Fatty Acid)

37 Progesterone

38 PSA

39 Reticulocyte Count (Flow Cytometry)

40 Rheumatoid Factor(RF/RA)

41 RLP[ Remnant Lipoprotein] cholesterol (ELISA)

42 Sputum Eosinophil & Neutrophil

43 TFPI [Tissue Factor Pathway Inhibitor] (ELISA)

44 TNF-alpha High Sensitivity (ELISA)

45 Transferrin saturation

46 TRAP(Tartrate Resistant Alkaline phosphatase)

47 Urine Alpha-GST (ELISA)

48 Urine Glucose

*Developed method available

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Sr. No Title

1ASTM-E1174 - Standard Test Method for Evaluation of the Effectiveness of Health Care PersonnelHandwash Formulations.

2 ASTM-E1054- Standard Test Method for Evaluation of Inactivators of Antimicrobial Agents.

3ASTM E1874 - Standard Test Method for Recovery of Microorganisms from Skin using the Cup ScrubTechnique.

4 In-vitro assay for evaluating the efficacy of Oral Care Formulations

5 Thiol production (BDCOH) assay for evaluating the effectiveness of Oral Care Formulations

6 EN-1276 Chemical disinfectants and antiseptics (under validation)

7 EN-13697 Chemical disinfectants and antiseptics (under validation)

8A cosmetic study to assess the effectiveness of test toothpaste formulation compared to a standardfluoride toothpaste and a commercially available toothpaste on plaque 1 and 12 hours after brushing.

9 Salivary sediment viability method

10Examine the effects of oral care formulations on oral (S.mutans ATCC 25175) bacteria used of time-killassay

11 Plaque Biofilm method time kill assay

12 Method for quantification of Cetylpyridinium chloride(cpc) from clay surface

13 Zone of Inhibition Method to check the effectiveness of antibacterial effect of Mouth wash

14Comparative evaluation of for viable spore count of Bacillus clausi after acid challenge and temperaturechallenge.

15To evaluate the efficacy of hand wash formulations, by measuring levels of residual bacterial count afterwashing/rinsing, based on ASTM E2870-13 method on the palms of normal volunteers


EVALUATION OF EFFECTIVENESS OF HEALTHCARE HYGIENE PRODUCTS

Validated Protocols

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INDIA: Lambda Therapeutic Research Ltd. Lambda House, Survey No. 388, Nr. Silver Oak Club, Off. S. G. Highway, Gota, Ahmedabad – 382 481, India Fax +91-79-40202021 Web: www.lambda-cro.com CANADA: Lambda Therapeutic Research Inc, 460 Comstock Road, Toronto, Ontario, Canada M1L 4S4 phone: +1416.752.3636 www.lambdacanada-cro.com

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