ZXFPC0074 Azithromycin /Azithromycin Dihydrate

CAS Number: 83905-01-5

Azithromycin Dihydrate

Appearance: White crystalline powder

Quality Index Standard Results

Identification: Rule of USP26 Conforms
Specific rotation: -45°-- -49° -47.3°
Crystallinity and Solubility: Rule of USP26 Conforms
PH: 9.0---11.0 9.96
Water: 4.0-5.0% 4.6%
Acetone: ≤0.5％ 0.27%
Residue on ignition: ≤0.3％ 0.06%
Heavy metals: ≤25ppm <25ppm
Assay: 945---1030μg/mg 975μg/mg

Conclusion: The Specification conforms to the rule of USP26.

　

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