| Powder: | Yes |
|---|---|
| Customized: | Non-Customized |
| Certification: | GMP, ISO 9001, USP, BP |
| Suitable for: | Adult |
| State: | Solid |
| Purity: | >99% |
| Customization: |
|---|
Suppliers with verified business licenses
Audited Supplier 
| Tests items | Acceptance criteria | Results | |
| Appearance | White or almost white powder | White powder | |
| IR Identification | Infrared spectrum is concordant with that of the reference standard | Conforms | |
| Appearance of solution | Solution S is clear and colorless | Conforms | |
| pH | 9.0-11.0 | 9.9 | |
| Specific optical rotation | - 45° ~ -49° (anhydrous substance) | - 47 ° | |
| Related substances | Impurity A | Not more than 0.5% | 0.03% |
| Impurity B | Not more than 2.0% | 0.14% | |
| Impurity C | Not more than 0.5% | 0.05% | |
| Impurity E | Not more than 0.5% | ND | |
| Impurity F | Not more than 0.5% | 0.006% | |
| Impurity G | Not more than 0.2% | ND | |
| Impurity H | Not more than 0.5% | ND | |
| Impurity I | Not more than 0.5% | 0.02% | |
| Impurity D+J+Q | Not more than 0.5% | ND | |
| Impurity L | Not more than 0.5% | ND | |
| Impurity M | Not more than 0.5% | 0.01% | |
| Impurity N | Not more than 0.5% | 0.02% | |
| Impurity O | Not more than 0.5% | 0.11% | |
| Impurity P | Not more than 0.5% | 0.02% | |
| Any other impurity | Not more than 0.2% | 0.03% | |
| Total impurities | Not more than 3.0% | 0.41% | |
| Water | 4.0%-5.0% | 4.3% | |
| Sulfated ash | Not more than 0.2% | 0.04% | |
| Assay | 96.0% ~102.0% (anhydrous substance) | 99.6% | |
| Residual solvents | Acetone | Not more than 5000ppm | 1556 ppm |
| Chloroform | Not more than 60ppm | ND | |
| Benzene | Not more than 2ppm | ND | |
| Microbial Limit |
Total Aerobic Microbial Count |
Not more than cfu103/g | <10 CFU/g |
| Total Yeast/Mold Count | Not more than cfu103/g | <10 CFU/g | |
Suppliers with verified business licenses
Audited Supplier 
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