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Pemetrexed Disodium 357166-30-4 Pemetrexed Disodium 357166-30-4

Pemetrexed Disodium 357166-30-4
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Basic information of Pemetrexed disodium:

Name

Pemetrexed disodium

Alias

Pemetrexed disodium for Injection; Pemetrexed Disodium 2.5 hydrate; Pemetrexed Disodium7 hydrate

CAS NO.

357166-30-4

Molecular Formula

2(C20H19N5Na2O6).5(H2O)

Molecular Weight

1032.84

Grade Standard

Medicine grade  / 99% min

Package Size

1kg/bag 

Storage:

Keep in a well-closed container, protected from light and stored at a temperature of 2 to 8


Use of Pemetrexed disodium: 

Pemetrexed disodium is combined with cisplatin for the treatment of inoperable malignant pleural mesothelioma. 

Pemetrexed is an antifolate preparation whose structure contains a pyrrolizidine group, which inhibits cell growth by disrupting the normal metabolic process of folate-dependent cells and inhibiting cell replication. In vitro studies have shown that pemetrexed inhibits the activity of thymidylate synthase, dihydrofolate reductase, and glycinamide nucleotide formyltransferase, which are essential enzymes for the synthesis of folic acid and are involved in thymidine nucleus. Bioresynthesis of glycosides and purine nucleotides. Pemetrexed enters the cell by a carrier carrying folic acid and a folate-binding protein transport system on the cell membrane. Once pemetrexed enters the cell, it is converted to the form of polyglutamate by the action of folate polyglutamate synthetase. Polyglutamate remains in the cell and becomes an inhibitor of thymidylate synthase and glycinamide nucleotide formyltransferase. Polyglutamination exhibits a time-concentration-dependent process in tumor cells with a low concentration in normal tissues. The half-life of the polyglutamate metabolite in the tumor cells is prolonged, thereby prolonging the action time of the drug in the tumor cells.

Preclinical studies have shown that pemetrexed inhibits the growth of mesothelioma cell lines (MSTO-211H, NCI-H2052) in vitro. A study of the mesothelioma cell line MSTO-211H showed a synergistic effect of pemetrexed in combination with cisplatin 

COA of Pemetrexed disodium:

Test Items

Standard

Test Results

Character

Almost-white or light yellow unfixed powder, smell-less, hygroscopic freely.

white unfixed powder, smell-less, hygroscopic freely.

Solubility

Soluble in water very freely, hardly soluble in ethanol or chloroform or ethyl ether.

Conforms

PH

6.5-8.5

7.2

Clarity and color of solution

Meet the requirements.

Conforms

Related substance

Max single impurity≤0.1%

0.036%

Total impurity≤0.5%

0.17%

Heavy Metal

<20ppm

Conforms

Water

7.2%-10.2%

8.8%

Chloride

≤0.02%

Conforms

Ethanol

≤5000ppm

1687ppm

Dichloromethane

≤600ppm

Not Detected

N,N-Dimethylformamide

≤880ppm

Not Detected



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MORE_DETAIL Pemetrexed Disodium 357166-30-4

Basic information of Pemetrexed disodium:

Name

Pemetrexed disodium

Alias

Pemetrexed disodium for Injection; Pemetrexed Disodium 2.5 hydrate; Pemetrexed Disodium7 hydrate

CAS NO.

357166-30-4

Molecular Formula

2(C20H19N5Na2O6).5(H2O)

Molecular Weight

1032.84

Grade Standard

Medicine grade  / 99% min

Package Size

1kg/bag 

Storage:

Keep in a well-closed container, protected from light and stored at a temperature of 2 to 8


Use of Pemetrexed disodium: 

Pemetrexed disodium is combined with cisplatin for the treatment of inoperable malignant pleural mesothelioma. 

Pemetrexed is an antifolate preparation whose structure contains a pyrrolizidine group, which inhibits cell growth by disrupting the normal metabolic process of folate-dependent cells and inhibiting cell replication. In vitro studies have shown that pemetrexed inhibits the activity of thymidylate synthase, dihydrofolate reductase, and glycinamide nucleotide formyltransferase, which are essential enzymes for the synthesis of folic acid and are involved in thymidine nucleus. Bioresynthesis of glycosides and purine nucleotides. Pemetrexed enters the cell by a carrier carrying folic acid and a folate-binding protein transport system on the cell membrane. Once pemetrexed enters the cell, it is converted to the form of polyglutamate by the action of folate polyglutamate synthetase. Polyglutamate remains in the cell and becomes an inhibitor of thymidylate synthase and glycinamide nucleotide formyltransferase. Polyglutamination exhibits a time-concentration-dependent process in tumor cells with a low concentration in normal tissues. The half-life of the polyglutamate metabolite in the tumor cells is prolonged, thereby prolonging the action time of the drug in the tumor cells.

Preclinical studies have shown that pemetrexed inhibits the growth of mesothelioma cell lines (MSTO-211H, NCI-H2052) in vitro. A study of the mesothelioma cell line MSTO-211H showed a synergistic effect of pemetrexed in combination with cisplatin 

COA of Pemetrexed disodium:

Test Items

Standard

Test Results

Character

Almost-white or light yellow unfixed powder, smell-less, hygroscopic freely.

white unfixed powder, smell-less, hygroscopic freely.

Solubility

Soluble in water very freely, hardly soluble in ethanol or chloroform or ethyl ether.

Conforms

PH

6.5-8.5

7.2

Clarity and color of solution

Meet the requirements.

Conforms

Related substance

Max single impurity≤0.1%

0.036%

Total impurity≤0.5%

0.17%

Heavy Metal

<20ppm

Conforms

Water

7.2%-10.2%

8.8%

Chloride

≤0.02%

Conforms

Ethanol

≤5000ppm

1687ppm

Dichloromethane

≤600ppm

Not Detected

N,N-Dimethylformamide

≤880ppm

Not Detected


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