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| Item | Test Method | Specification |
|---|---|---|
| Appearance | Organoleptic | White crystal or crystalline powder, odorless, slightly bitter, soluble in water |
| Identification | HPLC | Under assay test item, the retention time of the main peak of the tested sample solution should be consistent with that of the reference solution |
| Specific Optical Rotation, ° | General Rule 0621 | +18.0 ~ +20.0 |
| Melting Point, °C | General Rule 0612 | 170 ~ 176, simultaneous decomposition during melting |
| Clarity and color of the solution | General Rule 0902 | The solution should be clear and colorless |
| Loss On Drying, % | GB 5009.3 | ≤ 0.5 |
| Residue On Ignition, % | GB 5009.4 | ≤ 0.1 |
| Heavy Metals, ppm | General Rule 0821 | ≤ 10 |
| Assay (Dry basis), % | General Rule 0512 | 98.5 ~ 102.0 |
| Residual Solvents, mg/kg | General Rule 0861 | Methanol, ≤ 200 |
| General Rule 0861 | Ethanol, ≤ 5000 | |
| Aerobic Plate Count, CFU/g | GB4789.2 | ≤ 1000 |
| Molds and Yeasts, CFU/g | GB4789.15 | ≤ 100 |
| Escherichia. Coli, MPN/g | GB4789.38 | < 3.0 |
| Storage | Shading, airtight storage. | |
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