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Appearance
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White crystals or crystalline powder; soluble in water,in alcohol and in acetone
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Solubility
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Soluble in water, in alcohol and in acetone
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Identification (by IR)
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Passes USP test
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Assay (on dried basis)
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98.5% – 101.5%
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Residue on ignition
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NMT 0.4%
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Chloride and sulfate (Sulfate)
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NMT 0.03%
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Iron (Fe)
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NMT 30 ppm
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Related Substances ( by TLC)
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-
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Individual impurities
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Max. 0.5%
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Total impurities
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Max. 2.0%
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Specific optical rotation (at 589 nm) (c=8, 6 N HCl) on dried substance
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+5.7° to +6.8°
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Loss on Drying for (For 24 h in a vacuum desiccator using a suitable desiccant and maintaining a pressure of NMT 5 mm of mercury Hg)
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8.0 - 12.0%
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