| 01. |
Description |
A White to Off White Powder. |
| 02. |
Solubility |
Sparingly Soluble in water |
| 03. |
Identification |
A - Determine by IR |
| B - Determine by HPLC |
| 04. |
Enantiomeric Purity (HPLC) |
Impurity-B: Maximum 0.15% |
| 05. |
Related Substances by HPLC |
| Test A (Polar impurities) |
Impurities-C: Maximum 0.10% |
| Test B (Non-Polar impurities) |
Impurities-A: Maximum 0.15% |
| Impurities-D: Maximum 0.15% |
| Unspecified Non-Polar Impurity: Maximum 0.10% |
| Total Impurities |
Test A and B: Maximum 0.5% |
| 06. |
Sulphated Ash |
NMT 0.1% |
| 07. |
Heavy Metals |
NMT 20 ppm |
| 08. |
LOD (Loss on Drying) |
NMT 0.5% |
| 09. |
Assay by HPLC (Anhydrous substance) |
Between 98.0% to 102.0% |
| 10. |
Total Plate Count |
≤1000 CFU/g |
| 11. |
Mould and Yeast |
≤100 CFU/g |
| 12. |
Escherichia coli |
Absent in 1 gm |
| 13. |
Salmonella |
Absent in 10 gm |
