In This Store
Category:Active Pharmaceutical Ingredients > Other Active Pharmaceutical Ingredients
Product Name:97.5% up by HPLC, EP10.0, GMP Pemetrexed Disodium 150399-23-8
CAS No.:150399-23-8
Standard:USP, BP, EP, JP, In-house Standards
Price(USD):Negotiable
Company:Sinoway Industrial Co. Ltd
Grade: Pharmaceutical Grade
Factory Location: Xiamen, Fujian
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 |
Contact Us
Tel: (+86) 400 610 1188
WhatsApp/Telegram/Wechat: +86 13621645194
+86 15021993094
Follow Us: