 Mebendazole
USP |
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PRODUCT MEBENDAZOLE USP (POLYMORPH 'A'- WHITE) |
SPECIFICATION OF MEBENDAZOLE USP |
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S.NO |
TESTS |
SPECIFICATION |
| 1 | Description | White powder almost odourless |
| 2 | Solubility | Insoluble in water and most organic solvent freely soluble in formic acid. |
| 3 | Identification I.R. | As per U.S.P. |
| 4 | Melting Point | About 290 Deg.C |
| 5 | Chromatographic Purity | As per U.S.P. |
| 6 | Loss on Drying | 0.5% Max. |
| 7 | Residue On Ignition | 0.1% Max. |
| 8 | Heavy Metal | 0.002% |
| 9 | Assay (content of Mebendazole on dry basis) | 98.0% to 102.0% |