Current API product portfolio
Metoclopramide hydrochlorideSpecification:
|
|
| chemical name: | 4-amino-5-chloro-N-[2-(diethylamino)ethyl]-2-methoxybenzamide hydrochloride |
| molecular formula: | C14H23Cl2N3O2, H2O |
| structural formula: |  |
| molecular weight: | 354.3 |
| CAS Registery number: | 54143-57-6 |
General information: Appearance: white or almost white, crystalline powder or crystals. |
|
| TESTS | REQUIERMENTS | METHODS |
|---|---|---|
| Identification: First identification: A, B, D. Second identification: A, C, D, E. - pH of solution - IR spectrum - TLC - reaction of chlorides - reaction of primary aromatic amines |
4.5 to 6.0 comparison with reference substance spectrum the principal spot in the chromatogram obtained with the test solution (b) is similar in position and size to the principal spot in the chromatogram obtained with reference solution (a) conforms conforms |
Ph. Eur. |
| Appearance of solution | the solution is clear and colourless | Ph. Eur. |
| Related substances (TLC): - N,N-diethylethylenediamine - single other impurity |
not more than 0.5% not more than 0.5% |
Ph. Eur. |
| Heavy me |
not more than 20 ppm | Ph. Eur. |
| Water | 4.5% to 5.5% | Ph. Eur. |
| Sulphated ash | not more than 0.1% | Ph. Eur. |
| Content of metoclopramide hydrochloride calculated on anhydrous substance | 99.0% to 101.0% | Ph. Eur. |
| Residual solvents - methanol - acetone |
not more than 1500 ppm not more than 2500 ppm |
Ph. Eur. |
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