Customization: | Available |
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CAS No.: | 595-33-5 |
Formula: | C24h32o4 |
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ITEM | SPECIFICATION | RESULT |
Appearance | White or almost white crystalline powder | White crystalline powder |
Identification | IR spectrum isconcordant with the reference | Conforms |
Completeness of solution | 500 mg is dissolved in 10 mL of aceton e | Conforms |
Melting range | 213ºC to 220ºC:the range between beginning and end does not exceed 3°ºC | 217~219ºC |
Specific Rotation(in chlorofor m at 20ºC) | +8.8°to+12.0° | +11.0° |
Water | Not more than 0.5% | 0.03% |
Related Substances | 17α-Acetoxy Progesterone: Not more than 0.15% | Not detected |
Impurity A: Not more than 0.5% | 0.15% | |
Individual Unknown Impurity: Not more than 0.10% | 0.04% | |
Total impurities: Not more than 1.0% | 0.31% | |
Residue on Ignition | Not more than 0.2% | 0.05% |
Residual Solvents | Methano l: Not more than 1000ppm | 98ppm |
Dichloromethan e: Not more than 300ppm | 32ppm | |
Assay | Contains 97.0% to 103.0% | 99.7% |
CONCLUSION: | THE PRODUCT CONFORMS TO USP42 AND IN-HOUSE. |