Sinoway Industrial Co., Ltd

Date: 9th May 2016
Gemcitabine HCL
Sinoway Industrial Co.,Ltd is a famous China gemcitabine hcl manufacturer and supplier,Website:, welcome to buy GMP and EP gemcitabine hcl from us and check the price with us.Basic information of Gemcitabine HCL:NameGemcitabine hydrochlorideAlias2?,2?-difluorodeoxycytidinemonohydrochloride;2?-deoxy-2?,2?-difluorocytidinemonohydrochloride;2?-deoxy-2?,2?-difluoro-cytidinmonohydrochloride;gemzar;ly188011;ly188011hydrochloride;2',2'-DIFLUORO-2'-DEOXYCYTIDINE;2'-DEOXY-2',2'-DIFLUOROCYTIDINECAS NO.122111-03-9Molecular FormulaC9H12ClF2N3O4Molecular Weight299.66Quality StandardEP/USPPackage Size1kg/bag,25kg/drum or per your requestsUse of Gemcitabine HCL:Applicable to the treatment of inoperable advanced or metastatic pancreatic cancer and in the treatment of locally advanced or metastatic non small cell lung cancer (NSCLC), in the treatment of advanced non small cell lung cancer, non small cell lung cancer, pancreatic cancer, bladder cancer, breast cancer and other solid tumors.COA ofGemcitabine HCL:TestSpecificationResultCharactersWhite or almost white powderConformIdentificationThe IR spectrum of sample is concordant with the IR spectrum of Gemcitabine hydrochloride reference standard.ConformChlorideConformSolubilitySoluble in water; sparingly soluble in methanol, practically insoluble in alchohol and in polar organic solventsConformpH2.0 to 3.02.2Specific rotation+43? to +50?+49?Heavy metalsNot more than 10ppm<10ppmResidue on ignitionNot more than 0.1%0.06%Related substancesCytosine: not more than 0.1%0.02%?-anomer: not more than 0.1%Not detectedAny other impurity: not more than 0.1%0.04%Total impurities: not more than 0.2%0.10%Bacterial endotoxinsNot more than 0.05 EU/mg<0.05 EU/mgbacteriaNot more than 100 CUFU/g<10 CFU/gYeasts & MouldsNot more than 20 CFU/g<10 CFU/gEscherichia coliNot detectedNot detectedResidual solventsMethanol: not more than 0.3%0.0001%Acetone: not more than 0.5%0.16%Isopropyl alcohol: not more than 0.5%Not detectedEthylene Dichloride: not more than 5ppmNot detectedAssay97.5% to 101.5% ( on as-is basis)99.4%ConclusionConforms to USP34.
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