WHO Drug Information Vol. 24, No. 4, 2010

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WHO Drug Information Vol. 24, No. 4, 2010Consultation DocumentsThe International PharmacopoeiaCapreomycini sulfasCapreomycin sulfateDraft proposal for The International Pharmacopoeia (August 2010).Please address any comments to Quality Assurance and Safety:Medicines, World Health Organization, 1211 Geneva 27, Switzerland.Fax +41227914730 or e-mail to mendyc@who.int. A subscribermailing list is now available to speed up consultation. For moreinformation please contact bonnyw@who.int.Component R 1R 2Capreomycin IA OH -LysylCapreomycin IB H -LysylCapreomycin IIA OH HCapreomycin IIB H HCapreomycin IA: C 25H 48N 14O 16S 2; Capreomycin IB: C 25H 48N 14O 15S 2; Capreomycin IIA:C 19H 35N 12O 15S 2; Capreomycin IIB: C 19H 35N 12O 14S 2Relative molecular mass. Capreomycin IA: 864.9; Capreomycin IB: 848.9,Capreomycin IIA: 735.7; Capreomycin IIB: 719.7Chemical name. Capreomycin IA: (3S)-3,6-diamino-N-[[(2S,5S,8Z,11S,15S)-15-amino-11-[(4R)-2-amino-3,4,5,6-tetrahydropyrimidin-4-yl]-8-[(carbamoylamino)312
WHO Drug Information Vol. 24, No. 4, 2010Consultation Documentsmethylidene]-2-(hydroxymethyl)-3,6,9,12,16-pentaoxo-1,4,7,10,13-pentazacyclohexadec-5-yl]methyl]hexanamide;sulfuric acid.Capreomycin IB: (3S)-3,6-diamino-N-[[(2S,5S,8Z,11S,15S)-15-amino-11-[(4R)-2-amino-3,4,5,6-tetrahydropyrimidin-4-yl]-8-[(carbamoylamino)methylidene]-2-methyl-3,6,9,12,16-pentaoxo-1,4,7,10,13-pentazacyclohexadec-5-yl]methyl]hexanamide;sulfuric acid.Capreomycin IIA: [(Z)-[(3S,9S,12S,15S)-15-amino-9-(aminomethyl)-3-[(4R)-2-amino-3,4,5,6-tetrahydropyrimidin-4-yl]-12-(hydroxymethyl)-2,5,8,11,14-pentaoxo-1,4,7,10,13-pentazacyclohexadec-6-ylidene]methyl]urea; sulfuric acid.Capreomycin IIB: [(Z)-[(3S,9S,12S,15S)-15-amino-9-(aminomethyl)-3-[(4R)-2-amino-3,4,5,6-tetrahydropyrimidin-4-yl]-12-methyl-2,5,8,11,14-pentaoxo-1,4,7,10,13-pentazacyclohexadec-6-ylidene]methyl]urea; sulfuric acid.CAS Reg. No. 1405-37-4 (capreomycin sulfate).Description. A white or almost white powder.Solubility. Very soluble in water, practically insoluble in ethanol (~750 g/l) TS and inether.Category. Antituberculosis drug.Storage. Capreomycin sulfate should be kept in a tightly closed container or, if sterile,in a hermetically closed container.Labelling. The label states, where applicable:(1) that the substance is free from bacterial endotoxins,(2) that the substance is sterile.REQUIREMENTSDefinition. Capreomycin sulfate is the disulfate salt of capreomycin, a polypeptidemixture produced by the growth of Streptomyces capreolus. It contains not less than93.0% and not more than 102.0% of capreomycin sulfate, calculated with reference tothe dried substance and taking into account the sum of capreomycins sulfate IA, IB,IIA and IIB. The content of capreomycins sulfate IA and IB is not less than 90%.Identity testsEither tests A and E or tests B, C, D and E may be applied.A. Carry out the examination as described under 1.7 Spectrophotometry in the infraredregion. The infrared absorption spectrum is concordant with the spectrum obtainedfrom capreomycin sulfate RS or with the reference spectrum of capreomycin sulfate.B. Carry out the test as described under 1.14.1 Thin-layer chromatography, using silicagel R5 as the coating substance and a mixture of 30 volumes of phenol R, 10 volumes313
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