Doxycycline hydrochloride

Details:

Yellow crystalline powder antibiotics drug Items SPECIFICATIONRESULTAppearanceYellow crystalline powderCompliesIdentificationAs StipulatedCompliesIdentification AHPLCCompliesIdentification BSulphuric acid reaction a yellow colour developsCompliesIdentification CIt gives reaction of chloridesCompliesHeavy Metal≤50ppm<50ppmpH2.0-3.02.5Related substancea) 6-epidoxycycline≤2.0%1.8%b) metacycline≤2.0%0.2%c) 4-epidoxycycline≤0.5%Not foundd) 4-epi-6-epidoxycycline≤0.5%Not founde) oxytetracyclie ≤0.5%Not foundf) 2-acety-2-decarbamoyldoxycycline ADOT ≤0.5%Not foundg) any other impurity ≤0.5%Not foundh) not identified impurities≤0.1%Not foundSpecific Optical Rotation-105~ -120°-112°Specific absorbanceAt 349 nm E(1%) 300-335323Light absorbing impuritiesAt 490 nm ≤0.070.02Ethanol4.3-6.0% (m/m)4.9%Water1.4-2.8%1.9%Sulphated ash≤0.4%0.1%Assay95.0%-102.0% (C22H25ClN2O8) based on anhydrous, ethanol-free substance99.3%     Yellow crystalline powder antibiotics drug Items SPECIFICATIONRESULTAppearanceYellow crystalline powderCompliesIdentificationAs StipulatedCompliesIdentification AHPLCCompliesIdentification BSulphuric acid reaction a yellow colour developsCompliesIdentification CIt gives reaction of chloridesCompliesHeavy Metal≤50ppm<50ppmpH2.0-3.02.5Related substancea) 6-epidoxycycline≤2.0%1.8%b) metacycline≤2.0%0.2%c) 4-epidoxycycline≤0.5%Not foundd) 4-epi-6-epidoxycycline≤0.5%Not founde) oxytetracyclie ≤0.5%Not foundf) 2-acety-2-decarbamoyldoxycycline ADOT ≤0.5%Not foundg) any other impurity ≤0.5%Not foundh) not identified impurities≤0.1%Not foundSpecific Optical Rotation-105~ -120°-112°Specific absorbanceAt 349 nm E(1%) 300-335323Light absorbing impuritiesAt 490 nm ≤0.070.02Ethanol4.3-6.0% (m/m)4.9%Water1.4-2.8%1.9%Sulphated ash≤0.4%0.1%Assay95.0%-102.0% (C22H25ClN2O8) based on anhydrous, ethanol-free substance99.3%   &YYellow crystalline powder antibiotics drug Items SPECIFICATIONRESULTAppearanceYellow crystalline powderCompliesIdentificationAs StipulatedCompliesIdentification AHPLCCompliesIdentification BSulphuric acid reaction a yellow colour developsCompliesIdentification CIt gives reaction of chloridesCompliesHeavy Metal≤50ppm<50ppmpH2.0-3.02.5Related substancea) 6-epidoxycycline≤2.0%1.8%b) metacycline≤2.0%0.2%c) 4-epidoxycycline≤0.5%Not foundd) 4-epi-6-epidoxycycline≤0.5%Not founde) oxytetracyclie ≤0.5%Not foundf) 2-acety-2-decarbamoyldoxycycline ADOT ≤0.5%Not foundg) any other impurity ≤0.5%Not foundh) not identified impurities≤0.1%Not foundSpecific Optical Rotation-105~ -120°-112°Specific absorbanceAt 349 nm E(1%) 300-335323Light absorbing impuritiesAt 490 nm ≤0.070.02Ethanol4.3-6.0% (m/m)4.9%Water1.4-2.8%1.9%Sulphated ash≤0.4%0.1%Assay95.0%-102.0% (C22H25ClN2O8) based on anhydrous, ethanol-free substance99.3%