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Gemcitabine Hydrochloride CAS 122111-03-9 API USP35 Standard

Manufacturer with High Purity and Stable Quality Chemical Name: Gemcitabine Hydrochloride CAS: 122111-03-9 An Anticancer Agent API USP Standard, High Quality, Commercial Production
Chemical Name Gemcitabine Hydrochloride
Synonyms Gemcitabine HCl; 2'-Deoxy-2',2'-difluorocytidine; dFdC
CAS Number 122111-03-9
CAT Number RF-API41
Stock Status In Stock, Production Scale Up to Hundreds of Kilograms
Molecular Formula C9H12ClF2N3O4
Molecular Weight 299.66
Brand Ruifu Chemical
Item Specifications
Appearance White Crystal Powder, Odorless
Solubility Soluble in Water, slightly soluble in methanol, practically insoluble in acetone
Identifiaction IR IR spectrum should be concordant to that of the reference standard
Identifiaction Chloride Positive. It meets the requirements of the tests for chloride
Appearance of Solution Solution S in clear and not more intensely colored than reference solution BY7
pH 2.0~3.0
Specific Rotation +43.0° ~ +50.0°
Heavy Metals (Pb) ≤10ppm
Loss on Drying ≤1.0%
Residue on Ignition ≤0.10%
Related Substances
Cytosine ≤0.10%
α-Isomer ≤0.10%
Any Other Impurity ≤0.10%
Total Impurities ≤0.20%
Methanol ≤0.30%
Toluene ≤0.01%
Dichloromethane ≤0.01%
Acetone ≤0.50%
Assay 98.0%~102.0% (Calculated on dried base)
Test Standard United States Pharmacopeia (USP) Standard
Usage Active Pharmaceutical Ingredient (API)
Package: Bottle, Aluminum foil bag, Cardboard drum, 25kg/Drum, or according to customer's requirement. Storage Condition: Store in sealed containers at cool and dry place; Protect from light, moisture and pest infestation. Shanghai Ruifu Chemical Co., Ltd. is the leading manufacturer and supplier of Gemcitabine Hydrochloride (CAS: 122111-03-9) with high quality API. Gemcitabine Hydrochloride (CAS: 122111-03-9) is a clinically useful anticancer agent.1 It exerts its cytotoxic effects via the metabolites gemcitabine diphosphate (dFdCDP) and gemcitabine triphosphate (dFdCTP). dFdCTP is an inhibitor of DNA polymerase and is also incorporated in DNA strands resulting in termination of chain elongation and apoptosis. dFdCDP is an inhibitor of ribonucleotide reductase which results in depletion of deoxyribonucleotides needed for DNA synthesis. Gemcitabine metabolites have also been reported to inhibit cytidine triphosphate synthetase (CTP synthetase)2 and deoxycytidylate deaminase (dCMP deaminase)3. Topoisomerase 1 has also been shown to be a target for gemcitabine. Gemcitabine Hydrochloride (CAS: 122111-03-9) is a synthetic novel difluoro nucleoside drug that is anti-metabolic and antineoplastic. It is researched and developed by the Eli Lilly and Company and approved to be listed in South Africa, Sweden, the Netherlands, Australia and other countries in 1995. The United States Food and Drug Administration ( referred FDA) approved it as the first-line therapy for the clinical treatment of non-small cell lung cancer and pancreatic cancer. Gemcitabine hydrochloride, as a pro-drug, is a good substrate for the acidification of deoxygenation of thymine kinase phosphorus in the cell, and under the action of the enzyme, it can be converted into the following metabolites: gemcitabine mono-phosphate (dFdCMP), gemcitabine diphosphate (dFdCDP) and gemcitabine triphosphate (dFdCTP), among which the latter two are the active products.