CAS: 59-05-2
Structure:
Specifications: Conforms to standard USP 27 and EP4,BP2002
Text |
USP27 |
EP4 |
BP2002 |
Assay% |
98.0-102.0 |
98.0-102.0 |
98.0-102.0 |
Residue on ignition% |
≤0.1 |
|
|
Specific roataion |
+19-+24 |
+19-+24 |
|
Loss on drying% |
|
|
|
Chromatographic purity% |
≤2.0(total) |
|
|
|
≤0.5(individual) |
|
|
Water% |
≤12.0 |
≤13.0 |
≤12.0 |
Organic Volatile impurites |
conforms |
Sulphated ash% |
|
≤0.1 |
≤0.1 |
Heavy metals ppm |
|
50 |
1 |
Related substance |
|
|
|
Total |
|
≤1.3 |
≤1.3% |
Individual |
|
At most five peaks |
At most five peaks |
Impurity A% |
|
≤0.5 |
≤0.5 |
Impurity B% |
|
≤0.5 |
≤0.5 |
Impurity C% |
|
≤0.5 |
≤0.5 |
Impurity D% |
|
≤0.5 |
≤0.5 |
Impurity E% |
|
≤0.5 |
≤0.5 |
Unknown Impurity % |
|
≤0.5 |
≤0.5 |
(R)-Methotrexate% |
|
≤3.0 |
≤3.0 |
Physical properties:
Appearance: orange yellow crystal powders
Solubility: the production hardly dissolves in water, ethanol, chloroform or ether, and it easily dissolves in sparse alkali, and it can dissolve in dilute hydrochloric acid.
USE: The product is used as anti-tumour medicament.
Package: It's packed 2-ply polyethylene bags are heat sealed, Net weight 1KG/Tin.
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