Current API product portfolio
PiracetamSpecification:
|
|
| chemical name: | 2-oxo-1-pyrrolidineacetamide |
| molecular formula: | C6H10N2O2 |
| structural formula: |  |
| molecular weight: | 142.15 |
| CAS Registery number: | 7491-74-9 |
General information: Appearance: white or almost white, crystalline powder. |
|
| TESTS | REQUIERMENTS | METHODS |
|---|---|---|
| Identification: A. IR spectrum |
comparison with reference substance spectrum |
Ph. Eur. |
| Appearance of solution | clear and colouress | Ph. Eur. |
| Related substances: - pyrrolidin-2-one (A impurity) - methyl (2-oxopyrrolidin-1-yl)acetate (B impurity) - ethyl (2-oxopyrrolidin-1-yl)acetate (C impurity) - (2-oxopyrrolidin-1-yl)acetic acid (D impurity) - other single unspecified impurity - total impurities |
not more than 0.1% not more than 0.1% not more than 0.1% not more than 0.1% not more than 0.10% not more than 0.3% |
Ph. Eur. |
| Heavy me |
not more than 10 ppm | Ph. Eur. |
| Loss on drying | not more than 1.0% | Ph. Eur. |
| Sulphated ash | not more than 0.1% | Ph. Eur. |
| Content of piracetam calculated on dried substance | 98.0% - 102.0% | Ph. Eur. |
| Residual solvents: - methanol - acetone - toluene |
not more than 300 ppm not more than 100 ppm not more than 50 ppm |
POLPHARMA |
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