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Items
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Specification
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Results
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Appearance
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White or almost white, crystalline powder
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Complies
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Solubility
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Practically insoluble in water, freely soluble in ethanol,(96%), slightly soluble in methylene chloride
(96 percent), slightly soluble in methylene chloride
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Complies
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Identification
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Infrared spectrum corresponds to that of the standard preparation
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Complies
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The retention time of the major peak in the
chromatogram corresponds to that in the chromatogram of standard preparation
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Complies
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Related Substances by TLC
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Impurity A ((5Z,7E,22E)-24-cyclopropyl-1α,3β-dihydroxy-9,10-secochola-5,7,10(19),22-tetraen-24-one): NMT 0.25%
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Complies
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Impurity G (24,24-oxybis[(5Z,7E,22E,24S)-24-cyclopropyl-9,10-secochola-5,7,10(19),22-tetraene-1α,3β-diol]) : NMT 0.25%
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Complies
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Impurity H ((5Z,7E,22E,24R)-24-cyclopropyl-24-
[[(5Z,7E,22E,24S)-24-cyclopropyl-1α,3β-dihydroxy-9,10-secochola-5,7,10(19),22-tetraen-24-yl]oxy]-9,10-secochola-5,7,10(19),22-tetraene-1α,3β-diol): NMT 0.25%
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Complies
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Any other impurity : NMT 0.1%
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Complies
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Related Substances by HPLC
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Impurity B ((7Z)-calcipotriol) : NMT 0.5%
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ND
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Impurity C ((5E)-calcipotriol) : NMT 1.0%
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0.50%
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Impurity D (24-epi-calcipotriol) : NMT 1.0%
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0.66%
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Any other impurity: NMT 0.1%
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0.09%
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Total impurities : NMT 2.5%
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1.25%
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Residual Solvents
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Acetone : NMT 5000ppm
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630ppm
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Ethyl acetate : NMT 5000ppm
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ND
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n-Hexane : NMT 290ppm
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ND
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Methanol : NMT 3000ppm
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ND
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Dichloromethane : NMT 600ppm
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ND
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Loss on Drying
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NMT 0.5%
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0.27%
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Content
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95.5%-102.0% (dried substance)
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98.26%
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China
