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Contact SupplierSR.NO | TESTS | SPECIFICATION | RESULTS |
1. | Description | Yellow color crystalline powder | Complies |
2. | Identification | ||
a) By TLC | The principal spot obtained from the sample solution should correspond that of standard solution | Complies | |
b) By HPLC | The retention time of the major peak in the chromatogram of the sample should correspond to that in the chromatogram of the standard. | Complies | |
c) Melting Range | Between 137C to 140C | 138C - 139C | |
3. | Loss on drying at 80C | NMT 0.50 % | 0.45% |
4. | Related Substance by | ||
a) | 2-Amino-3,5-dibromo benzoic acid (IMP - A at RRT about 0.15) | Not more than 0.50 % | 0.20% |
b) | 2-Amino-3,5-dibromo benzyl alcohol (IMP - A at RRT about 0.5) | Not more than 0.50 % | 0.21% |
c) | Unknown impurity | Not more than 0.50 % | 0.10% |
d) | Total impurity | Not more than 2.00% | 0.80% |
5 | Assay By titration | Between 98% to 102% (w/w) | 99.80% |
6 | Sulphated Ash | Not more than 0.1% | 0.08% |