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Appearance
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Colourless crystals or a white crystalline powder; odourless
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Assay (Potentiometric; on anhydrous basis)
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99.0 - 101.0%
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Identifications
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To comply IP tests
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pH (2% w/v solution)
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4.5 to 6.2
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Related substance (by HPLC)
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Individual impurity
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Max 0.3%
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Sum of all impurities
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Max 0.5%
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Specific optical rotation (10% w/v solution)
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-0.50° to +0.05°
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Apoatropine (absorbance of a 0.1 per cent w/v solution in 0.01 M hydrochloric acid at about 245 nm)
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Max 0.4
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Foreign alkaloids and decomposition products (by TLC)
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To comply IP test
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Sulphated ash
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Max 0.2%
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Water (by KF)
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Max 4.0%
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