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 |
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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 |
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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.
