| Water | ≤0.5% |
| Impurity A | ≤0.3% |
| Impurity B | ≤0.3% |
| Specific rotation | -13.5° – -12-5° |
| Total impurity | ≤0.5% |
| Heavy metals | ≤10ppm |
| Total yeast &mold | ≤200cfu/g |
| pH | 3.5 – 5.5 |
| Impurity C | ≤0.1% |
| Impurity D | ≤0.1% |
| Solubility | Very soluble in water,slightly soluble in ethanol(96%) and in methanol, practically insoluble in acetone. |
| Assay (HPLC) | 98% – 102% (anhydrous basis) |
| Phosphate | ≤500ppm |
| Appearance | White / off-white powder |
| Residual Solvents: Methanol | ≤800ppm |
| Residual Solvents: Ethanol | ≤1000ppm |
| Identification IR | In accordance with standard spectra |
| Identification by HPLC | The retention time of the principal peak obtained with the test solution is identical with the reference solution. |
| Ecoli | Not detectable |
| Unknown individual impurity | ≤0.1% |
| Total amount of aerobe | ≤2000cfu/g |
