| Specification | Limits | Expt No.Val1 | Expt No.Val2 | Expt No.Val3 |
|---|---|---|---|---|
| Appearance | Off white to buff powder | Buff powder | Buff powder | Buff powder |
| Identification by HPLC | Should comply | complies | complies | complies |
| Loss of drying | NMT 1.0% | 0.54% | 0.24% | 0.26% |
| HPLC Purity | NLT 99.0% | 99.73% | 99.47% | 99.49% |
| Related substances by HPLC 1. Specified identified a) carbinol b) mesylate c) Ether impurity RRT 1.04 2. Specified unidentified impurity a. Impurity at RRT 1.6 b. Impurity at RRT 1.8 3. Unspecified unidentified single largest impurity 4. Total impurities |
NMT 0.15% NMT 0.1% NMT 0.15% NMT 0.15% NMT 0.15% NMT 0.1% NMT 0.5% |
Below LOQ Below LOQ Below LOQ Below LOQ Below LOQ 0.06% 0.13% |
Below LOQ Below LOQ Below LOQ Below LOQ Below LOQ 0.06% 0.15% |
Below LOQ Below LOQ Below LOQ Below LOQ Below LOQ 0.07% 0.10% |