DRUG NAME AVAILABLE IMPURITIES list.pdf · 2018-01-05 · DRUG NAME AVAILABLE IMPURITIES...

DRUG NAME AVAILABLE IMPURITIES

AlfuzosinHCl Imp-A,B,C,D,E

DIMER

Amlodipine

besilate

Methyl ester ofbenzene sulfonic

acid,

Ethyl ester of benzene sulfonic

acid,

Isopropyl ester ofbenzene sulfonic

acid,

Impurity-A,Phthalamidoamlodapine,

Impurity-B/

Partialyopendphathalamidoamlodapine,

Impurity-D/ Aromatic amlodipine,

Impurity-E/Dimethoxyamlodapine,

Impurity-F/ Para chloroamlodapine,

Impurity-G/Diethoxyamlodapine,

DimethoxyN-Succino Amlodipine(Imp-H)

Aprepitant Trans -1-enantiomer,S,R,S-Isomer

Aripiprazole

,DHC,

DCPP HCl,

DehydroAripiprazole ,

Dimer,

dehydro,

Dimer,

N-Oxide

Imp.-1,

N-Oxide

Imp.-2

Aripiprazole

AtomoxetineHcl NMPP impurity,

N-Acetyl ,

S-Isomer

Atorvastatin

Calcium

Methyl ester,

Ethyl ester,

Heptenoic acid,

Lactone imp,

Diketo compound,

Tertiary butyl ester,

Difluoro impurity,

Oxirane impurity,

BHA,SS isomer,

Desfluoro impurity ,

diasteriomer,

Di Amino impurity,

Methoxy

(주) 유켐 Tel: 070-8718-1830 Fax: 031-349-8718 E-mail: [email protected]

All EP Impurities (A to H) & I

Bicultimide EP-A,B,C,G(

E& F(Mixture)

In House Impurities also availabe

Bortizomib

SS,RR(Diasteriomer) ,

SR,Imp-G,

Enantiomer,

SS-OH,

SR-Hydroxy

Candesartan

Cilexetil

Desethyl impurity,

ACID IMP,

Ethyl candesartan

Candisatran EP-A,B,G,H,

Ethyl Candisatran ,

Des Ethyl

Capacitabine

Cetirizine

Dihydrochloride

Impurity-A,

Impurity-B,

Impurity-C,

3-Chloro analog,

Impurity-D,

3-Chloro ,

2-Chloro ,

Impurity-E,

Impurity-F,

Ethyl ester mpurity,

Methyl ester

Ciprofloxacin HCl

EDA,

Chloroanalog,

BIPRODUCT,

Desfluoro,

Q.Acid,

Decarboxylated imp

Citalopram EP-A ,

USP-C,D,E ,

Butryl Analog

Clopidogrel

Premix

Impurity-A ,B ,C ,D,E ,F,G ,

3 Isomer,

4 Isomer,

Alchohol impurity,

4 Acid

Related compound-A ,B , C (USP)


Donepezil HCl

EP-A,B,C,D,E ,

Hydroxy

Indene Impurity,

Desketo impurity,

Methyl impurity,

Dibenzyl impurity,

Alkene Impurity

Doxazosinmesylate Impurity-A,B,C,D,E,F,G,H

Dulaxitine All EP Impurities

Dutasteride

EP-A,B,C,D,E

Dihydro impurity,

Dihydro ,

DesmethylDutasteride,

ISOMER

Enalapril maleate Impurity-B,C,D,H,G,I

Escitalopram

Oxalate salt ,

Amide impurity,

R-Isomer,

Des methyl impurity,

carbaxylic acid citalopram,

Diol citalopram,

Other isomer ,

Imp-E,

Benzofurananalog,

DPTTA Salt,

Butyryl impurity,

Impurity E/4-Fluoro ,

Benzene analogue

Esomeprazole A,B,C,D,E,H,G,F

Ezetimibe

Other isomer,

3-Fluro isomer,

Desfluoro impurity

SRR ,

BENZYL IMPURITY ,

RSR

Diol

Famotidine

Impurity A,B,C,D,J,F,I,E ,H,

cyclic impurity

Fexofenadine HCL

Related compound-A,

Related compound-B,

Keto Ester,

Cyclopropyl acid ,


Dehydrated Imp,

Decarboxylated Imp,

Hydroxy Ester

Finasteride Impurity- A,B,C,D,

Isomer,

Form-2

Finofibrate USP-A,B

EP-F,D

Fluoxetine Hcl Related compound-B(USP),

Imp-A,C ,D ,E

GalantamineHBr (+) Galantamine

Gatifloxacin

8-Methoxy quinolonic acid,

8-Hydroxy of Gatifloxacin,

Ethyl Quinolonic ester,

3,4-Dimethyl,

piperazine derivative

Glimepiride

Impurity-D,B,C,D,

Recemic mixture ,

Methyl ester Impurity,

Imp-C- Inhouse

Ibuprofin Impurity-C

Iribisatran InHouse Impurities also available

Itracanazole -A,B,C,D,E,F,G

Keterolac

Tromethamine,

hydroxy imp,

Keto imp,

Decarboxylated imp,

Bromo Impurity

Lacidipine

2-Formyl benzoic acid,

Impurity-A,B,Dimer imp,

Regio imp,

TPPO Imp,

Vinyl aldehyde impurity,

TPP Impurity,

Decarboxylated Impurity

Lamotrigene IMP-A ,B ,C ,E ,F

Lansoprazole Sulphide imp,

Sulphone imp

Levo acid Racemic mixture,

Levo acid isomer

LevocetirizineHcl Impurity-A,B,C,D,E,F

3-Chloroanalog,

S-isomer Imp,


Levofloxacin

Hemihydrate

EP-A,B,C,D,E,F

Racemic mixture,

Imp-A ,B ,C ,

N-Oxide mpurity,

Decarboxylated impurity,

OTHER ISOMER

Losartan

Potassium salt

O- Trityl imp,

Iso-Trityl imp,

Isolosartan

IMP-L,M

Meloxicam Imp-B,C,E ,G,F,

MemantineHCl

1-Hydroxy-3, 5-dimethyl Adamantane,

1, 3- dimethyl adamantine,

1-Chloro-3,5 -dimethyl ,

Adamantane

Mesalamin

Impurity-B,D,E, H,,I,J,L, N,M,O,QR,

Metoprolol

succinate

Metoprolol Compound A, B, C, D,

MetoprololDiol Impurity,

Epichlorohydrin imp

Montelukast

-A,B,C,D

Saturated analog,

Sulphoxide impurity,

Styrine impurity,

Nitrile impurity,

Keto impurity,

Other Isomer,

Amide impurity

MoxifloxacinHCl

EP- EP-A,B,C,D,E,F,

8-methoxy quinolonic acid ,

methyl ester,

8-methoxy quinolonic acid ,

8-hydroxy of Moxifloxacin,

RR-isomer,

N-Methyl piperazine imp,

8-hydroxy of Quinalonic acid,

Fluoro Impurity,

6,8-Dimethoxy moxi,

8-Ethoxy Moxi.

Naproxen

Impurity-A,B,C,D,E,

Epoxide Impurity,

Aldehyde Impurity ,

Oxime Impurity

Nebivolol Related -A,B,


SSSR-Peak,

RRRS-Peak,

A-Spot

Norfloxacin

Imp-B,G,H,

Impurity-F (chloro analogue),

Imp-C/Dimer,

Imp-E

Nor chloro Q-acid,

Ofloxacin Ethylester,

Desfluoro impurity

Olanzapin

Formyl impurity,

Desmethylimpurity,

N – Oxide,

Acetyl,

dimer,

Quaternary salt

Omeprazole Impurity-A, B,C,D,E,F,G,H,I

Omeprazole

Chloroompound,

Benzimidazole compound.

,Omeprazole Sulfide,

N-Alkylated Impurity,

Desmethoxy Omeprazole Impurity,

Sulfone Impurity,

N-Oxide Impurity

Ondansetron Impurity-A,C,D,E ,F,G,

Desmethyl impurity

Pantaprozole

Chloro impurity,

Benzimidazole,

N-alkylated ,

Sulphide imp,

N-oxide,

N-oxide sulphide,

Sulphone imp,

N-Methyl impurity/Impuirty-D,

N-Methyl impurity/Impuirty-F

Pantoprazole

Pantoprazole Chloro compound,

Benzimidazole compound,

Pantoprazole Sulfide Impurity,

Pantoprazole Sulphone Impurity

(Impurity- A),

Pantoprazole N-Oxide Impurity,

Pantoprazole Impurity-D+F (N-Methyl

Pantoprazole),

Pantoprazole N-Alkylated Impurity


Paroxetenehcl

Imp-E,

(+) NMP Impurity,

USP impurity-F,

USP impurity-C

Q.Acid

Methoxy impurity,

Chloro analog,

Methyl ester,

Des fluoro impurity,

Positional isomer ,

7-Fluoro,

6-ethoxy

Quetiapine All EP- Impurities

Rabeprazole

Sodium

Impurity-A,B,C,D,E,

N-Alkylated,

Chloro Compound

Ramipril Impurity-C ,D,E,F,G,O,N,

RRR Isomer ,

(R,R)-Isomer,

Ranitidine

Impurity-A,B,C,D,E,F,G,I,J,K,

Ran-N-Oxide,

BDMT

Repaglinide IMP-A,C,E (EP ),

R-isomer ,

Imp-A,Binhouse,

Risperidone

Deschloro imp,

Hydroxy. Imp ,Imp-A (E-Isomer), B(Z-

Isomer),C,E,F,H,I,J,K,L,M,

UnreducedRisperidone,

N-Oxide,

Quantarnary salt

Rivastigmine

DesmethylRivastigmine,

DimethylRivastigmine,

UndesiredIsomer,

Diparatolyl D-Tartaric acid

Rizatriptan

Benzoate

Impurity-A,J,

Hydrazone Impurity

Ropinrole

Amino phenyl acetic acid,

N-HydroxyRopinirole,

3-Oxo Impurity,

Despropyl impurity

Rosiglitazone

maleate

Maleic acid impurity,

Dehydro impurity,

IMP-2

Setraline EP-A,B,C,E,F,G


Sparfloxacin

Deamino,

Fluoroanalog,

Diamino,

Decyclopropyl,

Benzylanalog,

HYDROXY IMPURITY

Sumatriptan EP-A,B,C,E

Sumatriptan Impurity-A,B,C,D,E,F,G,H

Tadalafil

EP-A,B,C

Trans imsomer ,

Piperonal,

TransTadalafil,

L-Tadalafil,

N-Acetyl-D-Triptophan,

D-Triptophan,Methylester,

D-Triptophan,methyl ester

Tamsulosin

Hydrochloride

2-EPEM,

Imp-A,B,C,D,E,F,G,H

Telmisartan

Desmethyl,

DimerImp,

ChloroImpurity,

Impurity-B,

Nitrileimpurity,

Amideimpurity,

Diacid impurity,

4-methyl biphenyl-2-carboxilic acid,

4-methyl biphenyl-2-nitrile

Telmisatran EP-A,B,C,D,E,F

TerbinafineHcl

Impurity-1,Impurity-6/Dimer imp,

Impurity-3/Z-isomer,

Impurity-4/4-MethylTerbinafine,

4-Methyl Methoxy impurity ,

EE-Impurity,

Impurity-2,Beta Terbinafine,

Cis Isomer of Beta Terbinafine

Tizanidine Imp-A,B,C,D,E,F,

Topiramate Impurity-B,

Torsemide EP-A,B,C,D,E

Valcyclovir All EP Impurities

Valsatran EP-A,B,C


S. No Batch No Impurity structure API Cas No:

1 Alpha isomer O N

NH

O

HO F

O

O

P

O

NH

OO

O

Sofosbuvir

VardenafilHCl Benzoyl impurity,

Dimer impurity

Ziprasidone

Hydrochloride

HydroxyZiprasidone,

Imp-A

KETO-IMP,

Alcoholimp,

Impurity-B (USP/EP),

IMP-E IMP-C (EP),

IMP-D IMP-E (EP)

Zoledronic acid Imidazole -1-yl acetic acid,

Imidazole

Zolmitriptan

Desmethyl,

R-Isomer,

Hydroxyderivative,

Cyclisedimp,

Ester Imp

Zolpidemtartarate

Amide impurity,

Bromo,

Hydroxy,

dimer,

Methyl amine impurity,

impurityA,Cyano impurity,

3Acetic acid impurity,

impurity E/3-methyl impurity,

Impurity-A,

impurity E/3-Methyl acetopheneone

impurity

Zonisamide

2-hydroxy acetophenoneoxime,

4-hydroxy coumarin,Ammonium salt,

1,2-benzisonazole-3-methane sulfonic

acid,


2 DImer-impurity

ON

NH

O

O

F

O

O

P

O

NH O

O

O

P

ONH

O

O

O

3 L-Ala dimer impurity P

O

NH

O

O

OHN

O

O

4 3-isomer impurity

ON

NH

OO

F

HO

O

P

O

HNO

O

O

5 Sofosbuvir Desphosphate impurity O N

NH

O

HO F

HO

O

6 Phosphoramidate

P(S)

O

O

NH

O

(S)O

O

F F

F

FF

7 Sofosbuvir Desphosphate alpha-Isomer O N

NH

O

HO F

HO

O


8 Rivaroxaban Amino ethyl impurity O N

O

NNH2

O

O

Rivaroxaban

446292-10-0

9 Rivaroxaban phthalimido descarbonyl impurity

O

N

O

HN

N

O

O

HO

446292-07-5

10 Rivaroxaban phthalimido impurity

O N

O

NN

O

OO

O

446292-08-6

11 Linezolid amine impurity O N NH2

H2N

Linezolid

93246-53-8

12 Linezolid phthalimido descarbonyl impurity

O

N

HN

N

O

O

HO

F

874340-08-6

13 Linezolid phthalimido impurity

O N NN

O

OO

OF

168828-89-5

14 Linezolid Amino ethyl impurity O N N

NH2

O

OF

168828-90-8

15 Des chloro impurity N

N

O

OH

Paliperidone

849903-79-3

16 Amine Impurity

HN

N O

F

84163-13-3

17 Chloroethyl Impurity N

N

O

Cl

OH

130049-82-0

18 Quetiapine Lactam

S

HN

O

Quetiapine 3159-07-7


19 Quetiapine USP RC B

S

HN

N

NH

111974-74-4

20 Rabeprazole sulfone n-oxide

N

HN

S

N

O

OO

O

O

Rabeprazole

924663-37-6

21 Rabeprazole N-oxide

N

HN

S

N

O

OO

O

924663-38-7

22 Rabeprazole Sulfide n-oxide

N

HN

S

N

O

OO

924663-40-1

23 Rabeprazole chloro imp Cl

N

OO

153259-31-5

24 2-mercaptobenzimidazole

N

HN

SH

583-39-1

25 9-Hydroxy Risperidone N

N O

FN

NHO

O

Risperidone 144598-75-4

1)Amlodipine iso propyl analog imp 2)Atorvastatin desfluoro imp 3)Atovaquinone ep imp-A 4)Atorvastatin enantiomer imp 5)Aripiprazole imp-D 6)Aripiprazole N-oxide imp 7)Almotriptan imp-A 8)Atenolol imp-H 9)Atorvastatin imp-C 10)Clopidrogrel imp-B 11)Ciprofloxavin des fluoro imp(ep imp-B) 12)celecoxib ep imp-A 13)Celecoxib ep imp-B 14)Abacavir tertiory butyl derivative imp 15)Clarithromycin imp-G


16)Darfenacin dimer imp 17)Duloxatine USP imp-B 18)Desvenlafloxacin N-oxide 19)Desvenlafloxacin 0.9 rrt imp 20)Enrofloxacin regio isomer of acrylate imp 21)Enrofloxacin des fluoro imp 22)Eletriptan dehydro acetyl imp 23)Enrofloxacin .HCl chloro analog imp 24)Enrofloxacin chloro analog imp 25)Etiroxib des chloro imp 26)Enrofloxacin des fluoro imp 27)Ezetimibe keto imp 28)Ezetimibe MPZT-1 imp 29)Ezetimibe MPZT-2 imp 30)Ezetimibe SRS imp 31)Ezetimibe 2-fluoro imp 32)Etiroxib dimer imp 33)Efavirentz ep imp-A 34)Etiroxib ep imp-B 35)Frovatriptan S-ispmer imp 36)Fluconazole imp-B 37)Fluconazole imp-D 38)Itracanazole imp-E 39)Itracanazole imp-F 40)Loratadine imp-B 41)Loratadine chloro imp 42)Loratadine dichloro imp 43)Loratadine dichloro keto imp 44)Losartan potassium ep imp-F 45)Lomitragine ep imp-A 46)Lomitrigine ep imp-C 47)Montelukast keto imp(imp-F) 48)Montelukast michal adduct 49)Milaraciptran lactone imp 50)Omeprazole n-methyl imp 51)Paliperidone keto imp 52)Pragabalin imp-D 53)Pentaprazole sulfone imp 54)Pioglitazine imp-C 55)Perindrofil imp-B 56)Perindrofil imp-A 57)Propafenone imp-A 58)Propafenone imp-E 59)Quatifine dimer imp 60)Quentifine S-oxide imp 61)Rasagiline(R)-1-indamine imp 62)Sildenafil ep imp-A 63)Sildenafil ep imp-B 64)Sildenafil ep imp-C 65)Sildenafil ep imp-D 66)Sildenafil ep imp-E


67)Sildenafil N-des methyl imp 68)Sildenafil dimer imp 69)Sildenafil pyridine imp 70)Sildenafil cyclic compound 71)Sildenafil piperazine imp 72)Simvastatin imp-B 73)Osaltamivir WHO imp-C 74)Olanzapine N-oxide imp 75)Tamsulosin .HCl dimer imp 76)Tenofovir isopropyl imp 77)Trazadone N-oxide imp 78)Telmisartan amide imp 79)Valacyclovir imp-J 80)Valacyclovir imp-H 81)Residronic acid ep imp-B 82)Rizartiptan N-Oxide imp 83)Zidovudine imp-A 84)Zidovudine imp-B 85)Zidovudine imp-D 86)Zidovudine UK imp 87)Carvedilol imp-C 88)Carvedilol imp-D 89)Dexlansoprazole methoxy imp 90)Losartan AG-2 imp 91)3-Thiophen rotigotine imp 92)Rotinovir imp-F 93)Quanapril USP related imp-B 94)Ciprofloxacin imp-E 95)Lurasidine isomer-I 96)Desmethyl erthromycin imp-B 97)Montelukast ester imp 98)Febuxostat amide imp 99)Febuxostat acid imp 100)Rasagiline chloro imp


DRUG NAME AVAILABLE IMPURITIES list.pdf · 2018-01-05 · DRUG NAME AVAILABLE IMPURITIES...

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Transcript of DRUG NAME AVAILABLE IMPURITIES list.pdf · 2018-01-05 · DRUG NAME AVAILABLE IMPURITIES...