Azithromycin
11,500 Per KG
25 KG (MOQ)
TESTING SPECIFICATION RESULT Characteristics (IP/EP) It is white almost white powder White Powder Solubility (EP/IP/USP) Practically insoluble in water solubility anhydrous ethanol and Confirms Specific Rotation EP/IP/USP - 45ᵒ ~ -49ᵒ - 48ᵒ Identification IR IR spectrum should meet the requirement Confirms HPLC LC chromatogram should meet the requirement Confirms Alkalinity EP/IP/USP 9.0~11.0 9.9 Solution clarity and color IP/EP Should be clear and colorless Confirms Crystallinity (USP) Birefringence and extinction Positions Confirms Water EP/IP/USP 4.0% ~ 5.0% 4.5% Residue on ignition IP/USP ≤ 0.2% 0.1% Heavy metal (IP) ≤ 10 ppm Confirms Residual Solvents Benzene ≤ 0.0002% Not Detected Methyl benzene ≤ 0.089% 0.0003% Triethyl amine ≤ 0.032% 0.0001% HPLC Assay USP C38H22N2O12 945 – 1030 g/ml 988/mg
Azithromycin
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