| 01. |
Description |
White or almost white to pale pink powder. |
| 02. |
Identification |
A. Determine by IR |
| B. Determine by HPLC |
| 03. |
Impurity E |
NMT 8 ppm |
| 04. |
Related Substances |
Impurity A - NMT 0.2% |
| Impurity B - NMT 0.2% |
| Impurity C - NMT 0.1% |
| Impurity D - NMT 0.3% |
| Other Impurity - NMT 0.10% |
| Total Impurity - NMT 1.0% |
| 05. |
Sulphated Ash |
NMT 0.6% |
| 06. |
Water |
NMT 0.5% |
| 07. |
Assay by HPLC |
97.5% to 102.0% |
| 08. |
Total Aerobic Microbial Count |
Not more than 1000 CFU/g |
| 09. |
Total Yeast and Mold Count |
Not more than 100 CFU/g |
| 10. |
Escherichia coli |
Absent/g |
| 11. |
Salmonella |
Absent/10 gm |
