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Home > Products >  GMP certificated GEMCITABINE HYDROCHLORIDE 122111-03-9

GMP certificated GEMCITABINE HYDROCHLORIDE 122111-03-9 CAS NO.122111-03-9

  • Min.Order: 1 Kilogram
  • Payment Terms: L/C,D/A,D/P,T/T,Other
  • Available Specifications:

  • Product Details

Keywords

  • Gemcitabine hydrochloride EP/USP
  • CAS:122111-03-9 Gemcitabine hydrochloride
  • 99% up Gemcitabine hydrochloride

Quick Details

  • ProName: GMP certificated GEMCITABINE HYDROCHLO...
  • CasNo: 122111-03-9
  • Appearance: white powder
  • Application: An antineoplastic. Suitable for the tr...
  • DeliveryTime: within 7-10 days after order
  • PackAge: 1kg/tin or per customer's requirement
  • Port: Beijing/Shanghai/Hangzhou/Shenzhen
  • ProductionCapacity: 1000 Kilogram/Month
  • Purity: 99%
  • Transportation: room temperature
  • LimitNum: 1 Kilogram
  • Related Substances: Total impurities: not more than 0.2%
  • Residue on Ignition: Not more than 0.1%
  • Heavy Metal: Not more than 10ppm
  • Valid Period: 2 years

Superiority

1) Specialized in pharmaceutical industry since from 1987

2) ISO 9001:2015 & SGS audited supplier 

3) Accept better payment terms : T.T 30-60 days.on the basic of pass SINOSURE credit investigation.

5) We have warehouse in USA with quickly shipment .

6) We can do different terms of FOB ,CIF/CIP ,DDP ...

Details

Company Information

Sinoway Industrial co., ltd. was established in 1987 in Xiamen, China, and now has been a leading group specialized in research, development, custom manufacturing and trading of pharmaceutical intermediates, APIs, health and food supplements, cosmetic raw materials, herbal extracts, polypeptides and prostaglandin derivatives, etc..

 

Product Description

Product name

Gemcitabine hydrochloride

Molecular Formula

C9H12ClF2N3O4

Molecular Weight

299.66

CAS No.

122111-03-9

Quality Standard

EP / USP, medical grade

Appearance

White powder

 

COA of Gemcitabine Hydrochloride

Test

Specification

Result

Characters

White or almost white powder

Conform

Identification

The IR spectrum of sample is concordant with the IR spectrum of Gemcitabine hydrochloride reference standard.

Conform

Chloride

Conform

Solubility

Soluble in water; sparingly soluble in methanol, practically insoluble in alchohol and in polar organic solvents

Conform

pH

2.0 to 3.0

2.2

Specific rotation

+43° to +50°

+49°

Heavy metals

Not more than 10ppm

<10ppm

Residue on ignition

Not more than 0.1%

0.06%

Related substances

Cytosine: not more than 0.1%

0.02%

α-anomer: not more than 0.1%

Not detected

Any other impurity: not more than 0.1%

0.04%

Total impurities: not more than 0.2%

0.10%

Bacterial endotoxins

Not more than 0.05 EU/mg

<0.05 EU/mg

bacteria

Not more than 100 CUFU/g

<10 CFU/g

Yeasts & Moulds

Not more than 20 CFU/g

<10 CFU/g

Escherichia coli

Not detected

Not detected

Residual solvents

Methanol: not more than 0.3%

0.0001%

Acetone: not more than 0.5%

0.16%

Isopropyl alcohol: not more than 0.5%

Not detected

Ethylene Dichloride: not more than 5ppm

Not detected

Assay

97.5% to 101.5% ( on as-is basis)

99.4%

Conclusion

Conforms to USP34.

 

 

Usage

Function of Gemcitabine hydrochloride

As a prodrug, gemcitabine hydrochloride is a good substrate for phosphorylation of deoxythymidine kinase in the cell and is converted into the following metabolites under the action of enzymes: gemcitabine monophosphate (dFdCMP), gemcitabine diphosphate (dFdCDP) and gemcitabine Phosphate (dFdCTP) dFdCDP and dFdCTP are active products. dFdCDP inhibits ribonucleotide reductase, thereby reducing the amount of deoxynucleotides required for repair of DNA synthesis (especially dCTP). Low levels of dCTP reverse the normal negative feedback inhibition of deoxyglycoside kinase, resulting in more dFdCTP Accumulation. At the same time, dFdCDP inhibits the deamination effect of dCTP-induced deoxycytidine on dFdCMP, and dFdCTP directly inhibits deoxycytidine deaminase, thereby converting more dFdCMP into the active metabolite dFdCMP deamination, and dFdCTP directly inhibits deoxygenation Cytidine deaminase, which converts more dFdCMP into the active metabolite dFdCDP, dFd-CTP and dFdCTP competes with dCTP for binding into the DNA strand, inserting it into the deoxycytidine site in the DNA strand, and allowing guanosine to interact with it After pairing, the gemcitabine molecule is "masked" by this guanosine to prevent it from being removed and repaired by exonuclease, and then DNA strand synthesis stops, and DNA breaks and the cell dies.

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