| Product name: | Biotin pure grade | |
|
Shelf life: |
Two years | |
| Inspection Standard: | USP 36 | |
| Items | Specifications | Results |
| Description | a White or off- white crystalline powder | Conform |
| IR | Match with the Reference IR Spectrum | Conform |
| Retention time | Should be similar to that of the reference solution | Conform |
| Specific Rotation | +89°～+93° | +89.95° |
| Assay | 97.5%～100.5% | 98.29% |
| Melting Point | 229℃～232℃， in-house | 230.5～231.5℃ |
| Individual impurity | ≤1.0% | 0.64% |
| Total impurities | ≤2.0% | 1.8% |
| Loss on Drying | ≤0.1%, in-house | 0.07% |
| Sulfated ash | ≤0.1%, in-house | 0.04% |
| Heavy Metal | ≤0.001%, in-house | ＜0.001% |
| Arsenic | ≤0.0003%, in-house | ＜0.0001% |
| Conclusion : Conform to USP 36. | ||