Vitamin B7/H (D-Biotin)
City: LV, Marupe
Please avoid sudden changes in temperature and humidity, as they may affect the condition of derivative ingredients and tablets.
The shelf life begins from the date of manufacture at the factory.
Taking into account logistical and transportation stages, the remaining shelf life of the product is always shorter than the full shelf life.
We ship products to our customers with a remaining shelf life of no less than 70%.
Identification
Test Item | Specification | Result | Method |
IR | Consistent with the Reference IR spectrum | Comply | USP2023 |
Specific rotation | +89° ~ +93° | +90.5° | USP2023 |
Retention time | Retention time of the major peak corresponds to that of the standard solution | Comply | USP2023 |
Physical & Chemical Tests
Test | Specification | Result | Method |
Description | Practically white, crystalline powder | Comply | USP2023 |
Loss on drying | ≤1.0% | 0.02% | EP11 |
Related Compounds
Test | Specification | Result | Method |
Individual impurity | ≤1.0% | 0.05% | USP2023 |
Total impurities | ≤2.0% | 0.05% | USP2023 |
Assay
Test | Specification | Result | Method |
Biotin | 99.0% ~ 102.0% | 99.8% | USP2023 |
Heavy Metals
Test | Specification | Result | Method |
Lead | ≤0.5 mg/kg | <0.5 mg/kg | ICP-OES, in-house |
Cadmium | ≤0.5 mg/kg | <0.5 mg/kg | ICP-OES, in-house |
Arsenic | ≤0.5 mg/kg | <0.5 mg/kg | ICP-OES, in-house |
Mercury | ≤0.1 mg/kg | <0.1 mg/kg | ICP-OES, in-house |
Microbials
Test | Specification | Result | Method |
Total Aerobic Microbial Count | NMT 100 cfu/g | <100 cfu/g | ChP2020 |
Total Yeasts and Moulds Count | NMT 10 cfu/g | <10 cfu/g | ChP2020 |
E. Coli | Negative | Negative | ChP2020 |
Salmonella | Negative | Negative | ChP2020 |
S. Aureus | Negative | Negative | ChP2020 |