TESTING ITEMS | SPECIFICATIONS | RESULTS |
Appearance | White or off-white, amorphous powder | Conform |
Identification | IR: same absorption bands as USP hydroxypropyl betadex RS | Conforms |
Clarity of solution: Positive | Conforms | |
Beta cyclodextrin | ≤0.1% | 0.08% |
1,4-butane sultone | ≤0.5ppm | 0.1ppm |
Sodium chloride | ≤0.2% | 0.07% |
4-hydroxybutane-1-sulfonic acid | ≤0.09% | 0.02% |
Bis(4-sulfobtyl)ether disodium | ≤0.05% | 0.01% |
Loss on drying | ≤10.0% | 2.6% |
Propylene oxide | ≤1ppm | 0.1ppm |
Conductivityer disodium | ≤200uS/cm | 59.8uS/cm |
The total Aerobic count | ≤100cfu/g | <10cfu/g |
The total Moulds and Yeast | ≤50cfu/g | <10cfu/g |
Bacterial Endotoxins | ≤20EU/g | <20EU/g |
E. Coli | Absence | Not detected |
PH | 4.0~6.8 | 5.4 |
Assay | 95.0%~105.0% | 99.90% |
Conclusion: The Product Conforms to USP. |