S.No | Test | Specification |
1 | Description | A White to Off-white crystalline powder |
2 | Identification by IR | IR chromatograph of sample should be similar to In-house standard |
3 | Solubility | Soluble in methanol, Acetone, Chloroform, Benzene and Insoluble in water |
4 | Melting range | 79°C – 83°C |
5 | Loss on drying | Not more than 1.0% |
6 | Sulphated ash | Not more than 0.2% |
7 | Related impurities by HPLC | |
a. Single maximum impurity | Not more than 1.0% | |
b. Total impurities | Not more than 2.0% |