Pemetrexed disodium 150399-23-8

97.5% up by HPLC, EP10.0, GMP

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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
Identification	(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.