Description
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White or almost white crystalline powder
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Identification
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a) IR spectrum
b) By HPLC
c) Chlorides
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Solubility
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Soluble in water
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Water
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Not more than 0.5% (Using 0.4g)
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Residue on ignition
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Not more than 0.1%
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Heavy metals
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Not more than 0.001%
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Limit of Dorzolamide
Hydrochloride related compound “A”
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Not more than 0.5%
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Chromatographic purity
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Individual impurity: Not more than 0.1%
Total imurities: Not more than 0.5%
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Assay (On anhydrous basis)
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99.0% ~ 101.0% (C10H16N2O4S3.HCl)
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