tems | Specifications | Results |
Appearance | White to off-white powder | Off-white powder |
Identification | IR: IR spectrum of the test sample correrponds to IR spectrum of the reference standard | comply |
Chloride: Complies with the test in the analytical procedure | comply | |
Loss on Drying | Not more than 0.5% | 0.20% |
Residue on Ignition | Not more than 0.5% | 0.30% |
Related Substances (HPLC) | T120-5D: NMT 0.1% | N.D. |
Any other individual impurity: NMT 0.1% | 0.01% | |
Total impurities: NMT 1.0% | 0.04% | |
Assay(Titration,on the dried basis) | 98.0%-102.0% | 100.3% |