Oxygen-18 Water Ancillaries Custom Synthesis Sterile Vials · Ancillaries Oxygen-18 Water Reagent...

Sterile Vials

Custom Synthesis

Ancillaries

Oxygen-18 Water

Reagent Kits

www.hic.cc

About Us

01 Huayi Isotopes Co. (HIC)

Huayi Isotopes Co. (HIC), a manufacturer of Oxygen-18 water, biochemical compounds and sterile components, is dedicated to leading-edge development of new biochemistry pla�orms cri�cal for the advancement of diagnos�c imaging.

We provide a broad catalog of products designed to meet the needs of our basic and applied research customers, as well as commercial cGMP products and services.We also offer custom synthesis, consul�ng expert and custom manufacturing services related to radiopharmacy and molecular imagining.

HIC has a cu�ng-edge research and development strategy geared toward mee�ng the emerging needs of the medical community with both commercial and academic collabora�ons in mind. Our molecular imaging pla�orm technology is adaptable to a broad range of radionuclides such as fluorine- 18, carbon-11 and techne�um-99m for Positron Emission Tomography (PET) and Single-Photon Emission Computed Tomography (SPECT) imging.Since 2002, HIC has been a trusted name in the radiopharmacy industry.

WT-9818O enriched water (98 atom%) GMP Grade

Applica�onFDG and other F-18 labelling biomarker produc�on

Standard Packing WT-98-0050 50 g / vialWT-98-0020 20 g / vialWT-98-0010 10 g / vial

WT-10Oxygen-18 Enriched Water /10 atom%

Applica�onPaleoclimatology and metabolic studies

Standard Packing WT-10-0100 100 mL / bo�leWT-10-1000 1 L / bo�le

DLW-1010 Doubly labeled water ( 10 atom% 18O, 10 atom% D)

Applica�onEnergy expenditure measurement in humans and animals

Standard Packing DLW-10-0100 100 mL / bo�leDLW-10-1000 1 L / bo�le

Oxygen-18 Water

Huayi Isotopes Co. (HIC) 02

Reagent Kits

Ancillaries

Casse�es

Reagent Kits & Ancillaries

Reagent Kits for- GE TRACERlab MX- GE TRACERlab FXFDG / FXF-N- GE TRACERlab C-Pro- IBA Synthera- Siemens Explora FDG4- ORA Nep�s- Scintomics GRP

- Cartridge- Sterile filter- Sterile syringe- Sterile needle- Other consumables

Casse�es for- GE TRACERlab MX- IBA Synthera- Trasis AIO/ Trasis Mini AIO- Nep�s


KT-110

SYNP

SYNC

KT-811-2

KT-115

KT-116

SYCC

SYNC

SYAP,SYDP

SYNP

MT-99-0025C

MT-99-0020A

MT-99-0020A

MT-99-0020B

MT-99-0020B

MT-99-0450D

MT-99-0030FH

BTE-95-0020A

NTTP-97-0010A

HCT-95-0002A

DMR-95-0002A

NTTP-97-0010B

Not included

AS-100A

AS-101

AS-200P

AS-200C

AS-500

AS-113

AS-115

AS-116

AS-103

AS-105

AS-106

AS-107

AS-112

AS-117

AS-201

AS-202

AS-203

AS-205

GE TRACERlab MX

GE TRACERlab FXFDG / FXF-N

GE TRACERlab FXFDG / FXF-N

IBA Synthera

IBA Synthera

Siemens FDG4

Trasis AIO/ Trasis Mini AIO

GE TRACERlab MX

GE TRACERlab MX

GE TRACERlab MX

GE TRACERlab FXF-N

GE TRACERlab FXF-N

GE TRACERlab FXF-N

GE TRACERlab FXF-N

GE TRACERlab C-Pro

GE TRACERlab C-Pro

GE TRACERlab C-Pro

IBA Synthera

IBA Synthera

IBA Synthera

IBA Synthera

Trasis AIO/ Trasis Mini AIO

Reagent KitCat. No.

Radiotracer Casse�e PrecursorAncillaries SetCat. No.

[18F]-FDG

[18F]-FDG(Acid Hydrolysis)

[18F]-FDG(Base Hydrolysis)

[18F]-FDG(Pharm. Grade)

[18F]-FDG(Chem. Grade)

[18F]-FDG(4Runs)

[18F]-FDG(1Run)

[18F]-FLT

[18F]-NaF

[18F]-Fcholine

[18F]-FLT

[18F]-Fluoro-ethylcholine

[18F]-Fluoroacetate

[18F]-FMISO

[11C]-Choline

[11C]-MET

[11C]–Raclopride

[18F]-NaF

[18F]-FLT

[18F]-Fluoromethylcholine

[18F]-FMISO

Ga-68 DOTA-X

RK-100

RK-102

RK-101

RK-210

RK-211

RK-500

RK-811-2

RK-113

RK-115

RK-116

RK-103

RK-105

RK-106

RK-107

RK-111

RK-112

RK-117

RK-201

RK-202

RK-203

RK-205

RK-816

SynthesisModule


Research Center for Biochemical CompoundsHIC provides custom synthesis services to academic and government ins�tu�ons, as well as some of the world' s leading corpora�ons, under strict confidence.

We supply the precursors for normal GMP produc�on, as well as some research compounds for new tracers.

Custom Synthesis

- Experienced scien�sts with PhD’s, chemical engineers, technicians

- Fully equipped laboratories include HPLC, GC, NMR, Waters PrepLC, etc.

- Custom packaging for all quan��es, including bulk quan��es

- cGMP produc�on in full compliance with ICH Q7A (for APIs)

- Confiden�ality guaranteed

- Technical support

- More than 300 PET precursors in stock


SPECT

PET

Beta-CIT

MIBG

IMZHippuran

etc.

IBZM

HDT

Reference standard only Precursor & reference standard Precursor only

Biochemical

Precursors & Reference Standards


DOTA-TOC DOTA DOTAEt NOTA

ABP688 ADIBO AMD Beta-CFT

Beta-CIT Choline DAA1106 DASB

Fallypride FAZA FDG FDOPA

FES FET FETA FHBG

FLB457 FLT Flumazenil Fluoro-2'-Deoxyadenosine

Fluoro-Altanserin Fluoro-Dopamine Fluoro-L-proline Fluoro-Setoperone

FMAU FMISO FMT FPD

Mefway MET ML-10 MPPF

MDL100907 NNC112 PBR06 PBR111

PBR28 PHNO PIB PK11195

Raclopride THK523 T-807 WAY10063518F-SFB and aryl fluoride Intermediates for Alkyl fluoride Click chemistry Reagent

F18 Ion Tracer etc.

HIC’s sterile vials are ISO 13485, ISO9001, CE and GMP-cer�fied. Our facility finishes the steriliza�on on the final product, allowing us to limit endotoxic level to meet strict specifica�ons.

Sterile Vial

Standard product format:- Type I glass vial- Straight plug rubber stopper - Transparent label- Flip top sealAll parts can be custom made. Refer to the following descrip�on.

SV——

SVV——

NSV——

SSV——

Sterile Vial (air-filled) flip top seal (trans. blue)

Sterile Vacuum vialflip top seal (blue )

Nitrogen-filled Sterile Vialflip top seal (trans. yellow)

Saline-filled Sterile Vialflip top seal (trans. green)


Height

Body diameter

Inner diameter

Outer diameter

Vial No.

Vol.(ml) Height

53.0±0.5mm

36.0±0.5mm

47.0±0.5mm

45.0±0.5mm

49.5±0.5mm

52.0±0.5mm

45.0±0.5mm

52.5±0.5mm

52.0±0.5mm

53.3±0.3mm

58.0±0.5mm

55.0±0.5mm

66.0±0.5mm

70.0±0.5mm

62.7±0.5mm

67.0±0.5mm

68.0±0.5mm

72.5±0.5mm

110.0±1.0mm

95.0.0±1.0mm

Outer diameter

12.8±0.2mm

19.8±0.2mm

19.8±0.2mm

19.8±0.2mm

19.8±0.2mm

19.8±0.2mm

19.8±0.2mm

19.8±0.2mm

19.8±0.2mm

20.0±0.2mm

19.8±0.2mm

19.8±0.2mm

19.8±0.2mm

19.8±0.2mm

19.8±0.2mm

19.8±0.2mm

19.8±0.2mm

19.8±0.2mm

28.1±0.2mm

19.8±0.2mm

Inner diameter

6.7±0.2mm

12.6±0.2mm

12.6±0.2mm

12.6±0.2mm

12.6±0.2mm

12.6±0.2mm

12.6±0.2mm

12.6±0.2mm

12.6±0.2mm

12.6±0.2mm

12.6±0.2mm

12.6±0.2mm

12.6±0.2mm

12.6±0.2mm

12.6±0.2mm

12.6±0.2mm

12.6±0.2mm

12.6±0.2mm

16.6±0.2mm

12.6±0.2mm

Body diameter

A selec�on of vials with all USP type I glass, with volumes ranging from 5ml to 100ml, is available. Please request detailed informa�on from our sales department.

Conven�onal Inventory

1000pcs 500pcs5000pcs

100/Tray

100/Tray

50/Tray

100/Tray

100/Tray

100/Tray

100/Tray

50/Tray

50/Tray

50/Tray

50/Tray

50/Tray

Cat. No. Packaging MinimumInventory

14.8±0.2mm

22.0±0.2mm

22.0±0.2mm

24.0±0.2mm

22.0±0.2mm

22.0±0.2mm

24.0±0.2mm

25.5±0.25mm

25.0±0.2mm

25.5±0.25mm

31.8±0.3mm

30.0±0.3mm

32.0±0.3mm

32.0±0.3mm

35.8±0.3mm

32.0±0.3mm

30.0±0.3mm

42.5±0.4mm

52.5±0.6mm

51.5±0.6mm

5.2ml

8.5ml

11.4ml

12.4ml

12.0ml

12.2ml

12.0ml

17.6ml

17.3ml

17.6ml

25.0ml

23.0ml

35.0ml

39.0ml

34.0ml

36.5ml

33.0ml

60.0ml

139.0ml

117.0ml

5A

5B

10A

10B

10C

10D

10E

15A

15B

15C

20A

20B,25A

30A

30B

30C

30F

30G

50A

100A

100B

NSV-10C

SV-10E

SV-30C

SVV-10A

SVV-10C

SVV-10D

SVV-15A

SVV-20A

SVV-20B

SVV-25A

SVV-30A

SVV-30C

Vial Size


Seal

Stopper

Label

Packaging

Wide range of stylesColor selec�on includes silver, yellow, red, blue and green

Available in Straight Plug, 1-Leg, 2-Leg and 3-Leg styles Material: Chloro butyl rubber stopper; Bromo butyl rubber stopper; Teflon-coated butyl rubber stopper

Transparent plas�c label (standard label)Without label

Double-layer packing for FDG dispensing

Sterile Vial

Standard packing for unidose dispensing


Quality Assurance

A complete GMP quality system has been established in accordance with ICH Q7a. The system has been audited and approved by various companies such as IBA, Siemens and GMS. It has also been cer�fied by the US Food and Drug Administra�on (FDA) (cGMP). It also holds ISO9001, ISO13485, and CE ceri�fac�on, by global qualifica�on organiza�ons such as Intertek, GTS and NQA. We are more than happy to support your specific local registra�on needs if necessary.

The staff is specially trained with an emphasis on adherence to work instruc�ons and the utmost a�en�on to quality.

All aspects, including material control, manufacturing process, quality control, supplier administra�on, etc. are defined in a set of Standard Opera�on Procedures.


China Huayi Isotopes Co. (China) 18 Fuyu Road, Haiyu TownChangshu, Jiangsu, P. R. China 215522Phone: +86 512-5249-1118Fax: +86 512-5245-1806E-mail: [email protected]

CanadaHuayi Isotopes Co. (Canada) 70 Fulton Way, Unit 102 Richmond Hill,Ontario, L4B 1J5 CanadaPhone: +1 416-298-3366Fax: +1 416-298-9366E-mail: [email protected]

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