| Customization: | Available |
|---|---|
| CAS No.: | 58-85-5 |
| Formula: | C10h16n2o3s |
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| Items | Requirements | Result |
| Appearance | Practically white, crystalline powder. | Complies |
| Identification IR | Consistent with the reference IR spectrum. | Complies |
| Specific rotation | +89°~+93° | +90.5° |
| Retention time | Retention time of the major peak corresponds to that of the standard solution. | Complies |
| Related compounds | Individual impurity≤1.0% | 0.04% |
| Total impurities≤2.0% | 0.04% | |
| Assay | 97.5%~102.0% | 100.0% |
| Heavy metals | Lead≤0.5 mg/kg | <0.5 mg/kg |
| Cadmium≤0.5 mg/kg | <0.5 mg/kg | |
| Arsenic≤0.5 mg/kg | <0.5 mg/kg | |
| Mercury≤0.1 mg/kg | <0.1 mg/kg | |
| Microbial limit | Total Aerobic Microbial Count: NMT 100 CFU/g | <100 CFU/g |
| Total Yeasts and Moulds Count: NMT 10 CFU/g | <10 CFU/g | |
| E.Coli: Negative | Negative | |
| Salmonella: Negative | Negative | |
|
S.Aureus: Negative
|
Negative | |
| Conclusion | This batch complies with USP43 and additional requirements for heavy metals and microbials. | |
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