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Amoxicillin Trihydrate USP 23, Micronised
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| TESTS | SPECIFICATIONS |
| Description | White or almost white crystalline powder |
| Identification | IR Spectrum |
| Solubility | ¡¡ |
| pH | 3.5 – 5.5 |
| Water (K.F) | 11.5 - 14.5 % |
| Rotation | +290¡Æ ~ +315¡Æ |
|
Related substances Total impurities (HPLC) Major individual Impurities |
¡¡ NMT 5.0% NMT 1.0% |
| Appearance of solution | By EP 98 |
| N,N-Dimethylaniline | NMT 20 ppm |
| Sulphated Ash | NMT 1.0% w/w |
|
Assay (as anhydrous basis, HPLC) |
95.0% ~ 100.5% |
| Expiration Date | 4 years from manufacturing date |