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Appearance
white or yellowish crystalline powder.
Solubility
: Practically insoluble in water, sparingly soluble in acetone, in ethyl acetate and in methanol.
Identification
I.R.
Melting Point: 206~211°C
Assay
98.0~102.0%
Specific Rotation
20°~ +24°( in methylene chloride)
Sulphated Ash
0.1%max
Related Substances(by HPLC)
17b-hydroxy-1a-methylandrost-4-en-3-one : 0.5%max
Any other impurity: 0.25%max
Total Impurities: 0.75%max
Disregard limit: 0.05%max
Impurity B(by TLC)
1a-methyl-5a-androstane-3b,17b-diol : 0.5%max
Particle Size
100%min ≤ 20 microns
Loss on Drying
≤0.5%
≥98.0%
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