Current API product portfolio
EthenzamideSpecification:
|
|
| chemical name: | 2-Ethoxybenzamide, o-Ethylsalicylamide |
| molecular formula: | C9H11NO2 |
| structural formula: |  |
| molecular weight: | 165.09 |
| CAS Registery number: | 938-73-8 |
General information: Appearance: a white to cream-white, odourless, powder. |
|
| TESTS | REQUIERMENTS | METHODS |
|---|---|---|
| Identification: A. UV spectrum B. IR spectrum |
maximum at 293 nm ± 2 nm comparison with reference substance spectrum |
POLPHARMA |
| Melting range | 129°C to 132°C | Ph. Eur. |
| Chromatographic purity (HPLC): - salicylamide - salicylic acid - any other impurity - total impurities |
not more than 0.2% not more than 0.1% not more than 0.1% not more than 0.5% |
POLPHARMA |
| Chlorides | not more than 0.0175% | POLPHARMA |
| Heavy me |
not more than 0.001% | Ph. Eur. |
| Readily carbonizable substances | colour is not more intensive than reference solution | POLPHARMA |
| Loss on drying | not more than 0.5% | POLPHARMA |
| Sulphated ash | not more than 0.1% | Ph. Eur. |
| Content of ethenzamide calculated on the dried substance | 98.0% to 101.5% | POLPHARMA |
| Residual solvents: - methanol |
not more than 1500 ppm |
POLPHARMA |
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