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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%