Basic Info.
Product Description
GMPActive Pharmaceutical Ingredient Methotrexate API Methylaminopterin Antineoplastic and Antirhe
Product Name: Methotrexate
Synonyms: Methotrexate;
Methylaminopterin;
Methylaminopterine;
antifolan;L-(+)-Amethopterin;
4-Amino-N 10-methylpteroyl-L-glutamic acid;
4-Amino-10-methylpteroyl-L-glutamic acid ;
(+)-4-Amino-10-Methylfolic acid; N-(p-(((2,4-Diamino-6pteridinyl)methyl)methylamino)benzoyl)-L-glutamic acid
CAS NO: 59-05-2
Specification: USP32-USP38
Molecular formula: C20H22N8O5
Molecular weight: 454.44
Appearance: Yellow or Orange crystal powder
Assay: 98%-102%
Usage: Used as a antineoplastic and antirheumatic. A folic Acid antagonist
Package: 1KG/bag, 5KG/bag, 25KG/drum
CERTIFICATE OF ANALYSIS
| PRODUCT NAME | METHOTREXATE | BATCH NO. | 20161003 |
| QUANTITY | 20KG | MAN.DATE | 2016.10.26 |
| TEST STANDARD | USP 32 | EXP. DATE | 2019.10.25 |
| TEST | SPECIFICATION | RESULT |
| Appearance | Yellow crystalline powder | Conforms |
| Identification | IR , UV conform | Conforms |
| Rotation | +19° - +24° | +21.0° |
| Water | NMT 12.0% | 10.5% |
| Residue on ignition | NMT 0.1% | 0.05% |
| Impurity C: NMT 0.5% | 0.1% | |
| Impurity B: NMT 0.3% | 0.09% | |
| Impurity E: NMT 0.3% | 0.12% | |
| Any unspecified imp.: NMT 0.1% | 0.07% | |
| Total unspecified imp: NMT 0.5% | Conforms | |
| Assay | 98.0 - 102.0% | 99.5% |
| CONCLUSION: The product conforms to the standard of USP 32. |