| 01. |
Description |
A White, crystalline powder. |
| 02. |
Identification – A |
Determine by IR |
| Identification – B |
Determine by HPLC |
| 03. |
Appearance of Solution |
Sample solution is less opalescent than Opalescence Standard OS2
and less intensely coloured than Reference Solution RS7.
(Should be clear and colorless like water)
|
| 04. |
Conductivity |
NMT 20 μS/cm |
| 05. |
Related Substance |
Impurity A: NMT 0.3% |
| Impurity B: NMT 0.3% |
| Other Impurity: NMT 0.1% |
| Total Impurities: NMT 1.0% |
| 06. |
Assay |
97.0% to 102.0% |
| 07. |
Water |
NMT 0.5% |
| 08. |
Lead (Pb) |
NMT 0.5 ppm |
| 09. |
Total Aerobic Microbial Count |
Not more than 1000 CFU/g |
| 10. |
Total Yeast and Mold Count |
Not more than 100 CFU/g |
| 11. |
Escherichia coli |
Absent/g |
| 12. |
Salmonella |
Absent/10 gm |
