Standard: USP28
Assay(on dry bases): ≥98.5-101.5%
Specific Rotation +21.4- +23.6°
Loss on Drying ≤0.2%
Residue on Ignition ≤0.1%
Sulphate ≤0.03%
Heavy Metals ≤20ppm
Chromatographic Purity: ≤0.5%(individual impurity)
≤2%(total impurities)
Organic volatile impurities Meets the requirements
Chloride 16.5%-17.1%
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