 Albendazole
USP |
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PRODUCT ALBENDAZOLE USP |
SPECIFICATION OF ALBENDAZOLE USP |
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S.NO |
TESTS |
SPECIFICATION |
| 1 | Description | White to pale buff coloured powder |
| 2 | Solubility | To comply as per USP |
| 3 | Identification | |
| a) IR Spectrum | To comply as per USP | |
| b) By TLC | To comply as per USP | |
| c) Melting point | Between 208 Deg to 210 Deg C | |
| 4 | Related substances (Chromatographic purity) | To comply as per USP |
| 5 | pH(2% w/w suspension) | Between 5.0 to 7.0 |
| 6 | Loss on drying | NMT 0.05% as per USP |
| 7 | Sulphated ash | NMT 0.20% as per USP |
| 8 | Bulk Density | NMT 10 ppm as per USP |
| 9 | Assay (on dry basis) | Between 98%-102% USP |
| 10 | Colour index at 450 nm | NMT 0.1 ABS (inhouse test) |
| 11 | Bulk density (150 taps) | Results to be noted |
| 12 | Residuc on ignition | NMT 0.2% as per USP |