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USP Grade Azithromycin Dihydrate Compacted Micronized Azithromycin Dihydrate CAS: 83905-01-51
Organic ChemicalsAzithromycinAzithromycin Dihydrate
Hubei Novcare Pharmaceutical Co., Ltd.
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Product Description ItemsRequirementsResultAppearanceIt is white or almost white crystalline powder, slightly hygroscopic.White crystalline powderSpecific Rotation-45°~-49°-47°IdentificationIR spectrum should meet the requirement.ConformsLC chromatogram should meet the requirement.ConformsPH Value9.0~11.010.2CrystallinityBirefringence and extinction positionsConformsWater4.0%~5.0%4.6%Residue on Ignition≤0.3%0.1%Related Substances Azaerythromycin A≤0.5% Not detected 3¨Deoxyazithronnycin (azithromycin B) ≤1.0% 0.7%Azithromycin C (3′ ′-O-demethylazithromycin) ≤ 0.5%Not detected3′-(N,N-Didemethyl)azithromycin(aminoazithromycin) ≤0.5%Not detectedN-Demethylazithromycin ≤0.7%Not detected2-Desethy1-2propylazithromycin ≤0.5% 0.2%Azithromycin impurity P ≤0.2% Not detectedAzithromycin related compound F ≤0.5%Not detected3′ -N-{[4-(Acetylamino) Phenyl]sulfonyl}-3-didemet hylazithromycin ≤0.5% Not detected Azithromycin N-oxide≤0.5% Not detected3′ -(N,N-Didemethyl)-3′ -N- formylazithromycin ≤0.5% Not detected3′ -De(dimethylamino)-3′ - oxoazithromycin≤0.5% Not detectedDesosaminylazithromycin≤0.3% Not detected3′ -N-Demethy1-3′ -N-[(4-methylphenyl)sulfonyl]azithromycin ≤0.5% Not detectedErythronaycin A iminoether≤0.5% Not detectedErythromycin A oxime ≤0.5% Not detected3-N-{[4-(Acetylamino)phenyl]sulfonyl}-3′ -dedemethylazithromycin ≤0.15% Not detectedAny other impurity ≤0.2% 0.1%Total impurities ≤3.0% 1.0%Residual solventsMethmol ≤0.3% 0.0015%Ethmol ≤0.5% 0.0038%cetone≤0.5% 0.1618%Dich1oromethme≤0.06% 0.0005%Benzene ≤0.0002%Not detectedMethylbenzene≤0.0892%0.0001%Triethylamine≤0.032%Not detectedAssay (HPLC) 945-1030ug/mg 995ug/mgConclusionThe product conforms to USP43 specification for Azithromycin.
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