Betamethasone, CAS 72-40-2
Item | Specification | Result |
Appearance | White or almost white crystalline powder | White crystalline powder |
Identification | IR spectrum Conforms to CRS. | Conforms |
Specific optical rotation | It should be +118°~+126° | +121.9° |
Related substance（By HPLC） | Single impurity less than 1.0% | 0.14% |
0.5%≤Impurity that ≤1.0% | Complies | |
Total impurity≤2.0% | 0.47% | |
Loss on drying | Less than 0.5% | 0.19% |
Organic volatile substances | ||
Methanol | Max.3000ppm | Complies |
Acetone | Max.5000ppm | Complies |
Ethyl acetate | Max.5000ppm | Complies |
DMF | Max.880ppm | Complies |
Dichloromethane | Max.600ppm | Complies |
Assay (UV) | Contains 97.0% to 103.0% of C22H29FO5 | 98.7% |
Conclusion: | Conforms To EP6.0 |
