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Email :PharmaSources@imsinoexpo.com
Whatsapp :+86-13621645194
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.