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: White or practically white, crystalline, odorless or practically odorless powder. Very soluble in water; freely soluble in alcohol; sparingly soluble in chloroform; practically insoluble in ether. |
|
| TESTS | REQUIERMENTS | METHODS |
|---|---|---|
| Identification A. IR spectrum B. chemical C. TLC |
corresponds to spectrum obtained with reference substance conforms the RF value of the principal spot in the chromatogram of the Identification preparation corresponds to that of Standard preparation A |
USP |
| Water | 4.5% to 6.0% | USP |
| Residue on ignition | not more than 0.1% | USP |
| Chromatographic purity: - single impurity - total impurities |
not more than 0.5% not more than 1.0% |
USP |
| Residual solvents - methanol - acetone |
not more than 1500 ppm not more than 2500 ppm |
USP |
| Content of metoclopramide hydrochloride calculated on anhydrous substance | 98.0% - 101.0% | USP |
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