Molecular Formula: C21H30O2
Molecular Weight: 314.468
Characters Identification: White or creamy white crystalline powder
Infrared absorption: The IR spectrum of sample exhibits maxima only at the same wavelength as that of a similar preparation of USP Progesterone RS.
Ultraviolet absorption: The UV absorption spectra of the test solution and the standard solution exhibit maxima at the same wavelengths.
Melting Range: Between 126°C and 131°C
Specific Rotation (on the dried basis): Between +175° and +183°
Loss on Drying: 0.5% Max.
Related Substances: Any impurity: 0.5% Max. Total Impurities: 0.8% Max.
Methanol: 500 ppm Max.
Ethanol: 2000 ppm Max.
Ethanol: 300 ppm Max.
Cyclohexanone: 50 ppm Max.
Assay (on the dried basis): 97.0% ~ 103.0%
Particle Size: 90% Min. through 20 μm