Product Name: Dydrogesterone
Molecular Formula:C21H28O2
Molecular Weight: 312.45
CAS No.:152-62-5
EINECS:205-806-8
Melting point: 168-173 ºC
Dydrogesterone is used as an effective, orally active progestogen for gynaecological conditions related to a wide variety of progesterone deficiencies in pregnant women.The molecular structureand pharmacological effects are somewhat similar to endogenous progesterone, although in smalleramounts it is found to be orally active. Its freedom from hormonal effects like those related to corticoid, androgenic, estrogenic, anabolic, and other effects gives dydrogesterone an advantage over other synthesized progestogens.
ITEMS | SPECIFICATION | RESULTS | |
Appearance | White or buff powder | White powder | |
Melting point | 133ºC--136ºC | 135--136ºC | |
Specific optical rotation | Conforms | Conform | |
Clarity and color of the solution | Clear | Clear | |
Related substances | Total impurity ≤1.5% | 0.18% | |
Nor-nocergoline (B)≤0.50% | 0.02% | ||
Chioronicergoline (A)≤0.5% | 0.04% | ||
MeLUOL (C)≤0.30% | 0.02% | ||
Unidentified impurity:≤0.30% | 0.06% | ||
Water | ≤0.5% | 0.06% | |
Heavy metal | ≤20ppm | Conform | |
Residue on ignition | ≤0.05% | 0.02% | |
Assay | 98.5%--102% | 99.3% | |
Residue solvents | Conform | Conform | |
1 | Acetone | ≤1000ppm | 450ppm |
2 | Diethyl ether | ≤2000ppm | 140ppm |
3 | Ethanol | ≤1000ppm | 40ppm |
4 | Methanol | ≤1000ppm | 90ppm |
5 | Toluene | ≤500ppm | 30ppm |
6 | Dichloromethan | ≤100ppm | <50ppm |
7 | Triethylamine | ≤500ppm | 230ppm |
Conclusion | Conform with EP 5.0 | ||
Storage :In the shade of dark and situation. And low temperature | |||
