| Item | Specification |
| Appearance | White powder |
| Identification |
HPLC:The principal peak in the chromatogram obtained
with the test solution is similar in retention time to the
principal peak in the chromatogram obtained with
reference solution.
|
| Related substances | Total impurity ≤5.0% |
| Single impurity ≤1.0% | |
| Water Determination | ≤1.0% |
| Residue on lgnition | ≤0.1% |
| Heavy Metals | ≤20ppm |
| Microbial Limit |
Total number of aerobic bacteria<100 cfu/g
|
| Total number of molds and yeast<100 cfu/g | |
| Assay | ≥99% |