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Items
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Specification
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Results
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Description
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White or practically white crystalline powder
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White crystalline powder
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Specific Rotation
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30°~-35°
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32°
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Melting Range
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232~239°C, and melting range is not more then 4°C
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234~238°C
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identification
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It complies with the test for specific optical rotation and melting point
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Conforms
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Infrared absorption spectrophotometry should be consistent with levonorgestrel CRS
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Conforms
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Loss on drying
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≤0.5%
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0.20%
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Residue on ignition
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≤0.3%
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0.07%
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Limit of Ethynyl Group
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7.81%~8.18%
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7.92%
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Related substances
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Single impurity ≤0.5%
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single impurity<0.5%
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Total Impurities ≤2.0%
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Total impurities<2.0%
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Organic Volatile impurties
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Ethanol ≤5000ppm
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1200ppm
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Assay
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The product complies with specification in USP34
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Particle Size
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D(0.9)<10μm
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Storage Condition
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Sealed, protect from light
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