• Characters: Appearance – white or yellowish-white powder, hygroscopic. - Solubility – very soluble in water, very slightly - Soluble in alcohol, practically insoluble in acetone.
• Identification: A (1) The retention time of a major peak meets the requirements. (2) Impurity C: conform. - B Positive
• pH: 5.0 – 7.5
• Specific optical rotation: +53.5° - +59.0°
• Related substances: Impurity A: NMT 2.0 % - Impurity C: 3 – 15 % - Any other impurity: NMT 5 % - Total of other impurities: NMT 15 %
• Sulfate (anhydrous): 27.0 – 31.0 %
• Loss on drying: NMT 8.0 %
• Sulfated ash: NMT 1.0 %
• Potency: NLT 680 IU/mg (dried substance)

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