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Levofloxacin

Human API

Characterised impurities

ImpurityChemical namePharmacopoeia
TAA (Insitu inter. of Levo. Esterhydroxypropan-2- yl)amino)-2-(2,3,4,5- tetrafluorobenzoyl)a crylate; (+)-ethyl-2- (2,3,4,5- tetrafluorobenzoyl)- 3-(1'S- hydroxymethylethyl amino)acrylateIHT
Leo Ester of Levofloxac in (LH1)(-)Ethyl-9,10- difluoro-3-S-methyl- 7-oxo-2,3-dihydro- 7H-pyrido[1,2,3- de]-1,4-benzoxazine- 6-carboxylate; Ethyl (S)-9,10-difluoro-3- methyl-7-oxo-2,3- dihydro-7H- pyrido[1,2,3-de]=1,4- benzoxazine-6- carboxylateIHT
Leo Acid N-oxide i.e. impurity "C" (EP) 2,3,4,5- tetra fluoro benzoic acid Racemic Leo ester (LF1)(S)-9,10-difluoro-3,7- dihydro-3-methyl-7- oxo-2H- [1,4]oxazino[2,3,4- i]quinoline-6- carboxylic acid (S)-4-(6-carboxy-9- fluoro-2,3-dihydro-3- methyl-7-oxa-7H- pyrido-[1,2,3-de] [1,4]benzoxazine-10- yl)-1-methyl- piperazine-1-oxide (USP); 4[(3S)-6- carboxy-9-fluoro-3- methyl-7-oxa-2,3- dihydro-7H- pyrido[1,2,3-de] [1,4]benzoxazin-10- yl]-1- methylpiperazine-1- oxide (EP) 2,3,4,5-tetra fluoro benzoic acid Ethyl-9,10-difluoro- 3-methyl-7-oxo-2,3- dihydro-7H- pyrido[1,2,3-de]-1,4- bezoxazine-6- carboxylate; Ethyl- 9,10-difluoro-3- methyl-7-oxo-2,3- dihydro-7H- [1,4]oxazino[2,3,4- ij]quinoline-6- carboxylateUSP USP IHT IHT
Levofloxac in acid ester/ Levofloxac in Acid (LFA) / Impurity F/ Related compound B(S)-9,10-Difluoro-3- methyl-7-oxo-2,3- dihydro-7H- pyrido[1,4]benzoxazi ne-6-carboxylic acidIHT
Impurity "B" / Related Compound "A" (USP)/ N- Desmethyl Levofloxac in 2,5-(S)-9-Fluoro-2,3- dihydro-3-methyl- 10-(piperazin-1-yl)-7- oxo-7H-pyrido[1,2,3- de][1,4]benzoxazine- 6-carboxylic acidd; (3S)-9-Fluoro-3- methyl-7-oxo-10- (piperazin-1-yl)-2,3- dihydro-7H- pyrido[1,2,3-de] [1,4]benzoxazine-6- carboxylic acidEP/USP
Dimethylpi perazine dihydrochl oride Impurity "G" (EP)/ Diamine derivative (USP)2,5- Dimethylpiperazine dihydrochloride (3S)-9-Fluoro-3- methyl-10-[[2- (methylamino)ethyl]- amino-7-oxo-2,3- dihydro-7H- pyrido[1,2,3-de][1,4]- benzoxazine-6- carboxylic acidIHT EP/USP

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