1 | Description | White, odorless crystals. | White, odorless crystals. |
2 | Solubility | Complies | Soluble in water and in alcohol; freely soluble in boiling water. |
3 | Identification A (By IR) | Complies | IR spectra of the sample should be concomitant with IR spectra of the standard |
4 | Identification B (By Chromatographic identity) | Complies | The retention time of the major peak of the sample solution corresponds to that of the standard solution, as obtained in the assay. |
5 | Assay | 99.7% | 99.0% - 100.5% |
6 | Residue on ignition | 0.020% | NMT 0.025% |
7 | Melting range | 185.9°C - 186.8°C | 185.0°C - 190.0°C |
8 | Particle size | 99.8% passes through 40 mesh and 98.5% retain on 140 mesh | NLT 98% passes through 40mesh and NLT 98% retain on 140 mesh |