98% up by HPLC EP/USP GEMCITABINE HYDROCHLORIDE 122111-03-9

Category:Active Pharmaceutical Ingredients > Other Active Pharmaceutical Ingredients
Product Name:98% up by HPLC EP/USP GEMCITABINE HYDROCHLORIDE 122111-03-9
CAS No.:122111-03-9
Standard:USP, BP, EP, JP, In-house Standards
Price(USD):Negotiable
Company:Sinoway Industrial Co.Ltd.

Basic Info
  • Grade: Pharmaceutical Grade

    Factory Location: Xiamen, Fujian

    Main Sales Markets: North America,Central/South America,Western Europe,Eastern Europe,Australasia,Asia,Middle East

  • Monthly Production Capacity: 1000kg

    Packaging Information: 25kg/drum 1kg/bottle

  • Delivery Lead Time: 7 days after payment

    Sample Provided: yes

    Payment Terms: L/L

    Product Information

     

    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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