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Pemetrexed disodium 150399-23-8

Pemetrexed disodium 150399-23-8

97.5% up by HPLC, EP10.0, GMP
  • Product Details

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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