TESTING ITEMS | SPECIFICATIONS | RESULTS |
Appearance | White or almost white powder | Conform |
Identification | IR: same absorption bands as USP hydroxypropyl betadex RS | Conforms |
Clarity of solution: Positive | Conforms | |
Molar substitution | 0.40~1.50 | 0.68 |
Loss on drying | ≤10.0% | 3.8% |
Beta cyclodextrin | ≤1.5% | 0.37% |
Any other single impurity | ≤0.25% | Not detected |
Total impurities | ≤1.0% | Not detected |
Propylene oxide | ≤1ppm | 0.1ppm |
Conductivity | ≤200uS/cm | 59.8uS/cm |
The total Aerobic count | ≤1000cfu/g | <10cfu/g |
The total Moulds and Yeast | ≤100cfu/g | <10cfu/g |
Assay | ≥98.0% | 99.70% |
Conclusion: The Product Conforms to USP. |