S. No. | TEST | SPECIFICATION | |
1. | Description | White to cream/off-white powder | |
2. | Identification by HPLC | The retention time of the major peak in the chromatogram of the test preparation corresponds to that in the chromatogram of standard preparation as obtained under purity by HPLC. | |
3. | Water by KF | Not more than 0.50% | |
4. | Ionic chloride by titration | 16.2% - 18.2% w/w | |
5. | Total chloride by titration | 32.4% - 34.4% w/w | |
6. | LOD (at 60ÂșC U/VAC) | Not more than 2.0% | |
7. | Purity by HPLC | Not less than 99.0% |