97.5% up by HPLC, EP10.0, GMP Pemetrexed Disodium 150399-23-8

Category:Active Pharmaceutical Ingredients > Other Active Pharmaceutical Ingredients
Product Name:97.5% up by HPLC, EP10.0, GMP Pemetrexed Disodium 150399-23-8
CAS No.:150399-23-8
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

    Pemetrexed disodium

    CAS No.

    150399-23-8

    Molecular Formula

    C20H19N5Na2O6

    Molecular Weight

    471.374

    Quality Standard

    97.5% up by HPLC, GMP, EP10.0

    Appearance

    White powder

     

    COA of Pemetrexed disodium

     

      Items

    Specifications

    Results

    Appearance:

    White or almost white powder

    Conform

    Solubility

    Freely soluble in water, very slightly soluble in anhydrous ethanol, practically insoluble in methylene chloride.

    Conform

    Identification

    (1)     IR: The IR spectrum is in accordance with that of reference

    Conform

    (2)    Sodium salt: Positive

    Positive

    Appearance of solution

    Not more opalescent than reference suspension II and not more intensely coloured than reference solution GY4

    Conform

    pH

    7.5-8.4

    8.1

    Enantiomeric purity

    NMT 0.3%

    0.04%

    Related substances

     

     Impurity A

    NMT 0.15%

    0.03%

     Impurity D

    NMT 0.15%

    0.01%

     Individual impurity

     NMT 0.10%

    0.01%

     Total impurities

     NMT 0.6%

    0.09%

    Water

    19.5%-22.1%

    21.9%

    Heavy metals

     NMT 20ppm

    < 20ppm

    Residual solvents

     

     Ethanol

     NMT 5000ppm

    742ppm

     Acetone

     NMT 5000ppm

    ND

     Dichloromethane

     NMT 600ppm

    ND

     N-methyl morpholine

     NMT 280ppm

    ND

     DMF

     NMT 880ppm

    ND

    Microbial limits

     

     TAMC

    NMT 103 CFU/g

    < 1x10 CFU/g

     TYMC

    NMT 102 CFU/g

    < 1x10 CFU/g

    Bacterial endotoxins

    < 0.17EU/mg

    < 0.17EU/mg

    Assay (anhydrous basis)

    97.5% - 102.0%

    98.5%

    Conclusion

    Meet the specification of EP10.0

     

     

    Usage

     

    Function of Pemetrexed disodium

    Pemetrexed disodium for injection is mainly used for lung cancer and mesothelioma. The effect of lung cancer and pancreatic cancer is the best. In recent years, it has become the first-line chemotherapy regimen for lung adenocarcinoma chemotherapeutics. It is often used in combination with platinum-based drugs to achieve better therapeutic effects.

     

    Pemetrexed enters the cell through the carrier carrying folic acid and the folic acid binding protein transport system on the cell membrane. Once pemetrexed enters the cell, it is converted into polyglutamate form under the action of folyl polyglutamate synthetase. Polyglutamic acid remains in the cell and becomes an inhibitor of thymidylate synthase and glycinamide nucleotide formyltransferase. Polyglutamination presents a time-concentration-dependent process in tumor cells, while the concentration in normal tissues is very low. The half-life of polyglutamate metabolites in tumor cells is prolonged, thereby prolonging the action time of the drug in tumor cells.

    Preclinical studies have shown that pemetrexed can inhibit the growth of mesothelioma cell lines in vitro. Studies on mesothelioma cell lines have shown that the combination of pemetrexed and cisplatin has a synergistic effect.

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