Vancomycin
C66H75Cl2N9O24 1449.25
Vancomycin. Vancomycin.

(Sa)-(3S,6R,7R,22R,23S,26S,36R,38aR)-44-[[2-O-(3-Amino-2,3,6-trideoxy-3-C-methyl-a-L-lyxo-hexopyranosyl)-b-D-glucopyranosyl]oxy]-3-(carbamoylmethyl)-10,19-dichloro-2,3,4,5,6,7,23,24,25,26,36,37,38,38a-tetradecahydro-7,22,28,30,32-pentahydroxy-6-[(2R)-4-methyl-2-(methylamino)valeramido]-2,5,24,38,39-pentaoxo-22H-8,11:18,21-dietheno-23,36-(iminomethano)-13,16:31,35-dimetheno-1H,16H-[1,6,9]oxadiazacyclohexadecino[4,5-m][10,2,16]-benzoxadiazacyclotetracosine-26-carboxylic acid.
[3S-[3R*,6S*(S*),7S*,22S*,23R*,26R*,36S*,38aS*]]-3-(2-Amino-2-oxoethyl)-44-[[2-O-(3-amino-2,3,6-trideoxy-3-C-methyl-a-L-lyxo-hexopyranosyl)-b-D-glucopyranosyl]oxy]-10,19-dichloro-2,3,4,5,6,7,23,24,25,26,36,37,38,38a-tetra-decahydro-7,22,28,30,32-tahydroxy-6-[[4-methyl-2-(methylamino)-1-oxopentyl]amino]-2,5,24,38,39-pentaoxo-22H-8,11:18,21-diethno-23,36-(iminomethano)-13,16:31,35-dimetheno-1H,16H-[1,6,9]oxadiazacyclohexadecino[4,5-m][10,2,16]-benzoxadiazacyclotetraine-26-carboxylic acid [1404-90-6].
»Vancomycin has a potency equivalent to not less than 950µg of vancomycin per mg,calculated on the anhydrous basis.
Packaging and storage— Preserve in tight containers.
Identification—
A: Infrared Absorption á197Kñ.
B: It does not respond to the test for Chloride á191ñ.
Water,Method Iá921ñ: not more than 20%.
Chromatographic purity—
Triethylamine buffer,Solution A,Solution B,Mobile Phase,Resolution solution,andChromatographic system —Prepare as directed in the test for Chromatographic purityunder Vancomycin Hydrochloride.
Test preparation A— Transfer about 250mg of Vancomycin to a 25-mLvolumetric flask,add 5mLof Mobile phase A,then add 0.1Nhydrochloric acid dropwise with swirling until dissolution is achieved.Dilute with Mobile phase Ato volume,and mix.
Test preparation B— Transfer 2.0mLof Test preparation Ato a 50-mLvolumetric flask,dilute with Mobile phase Ato volume,and mix.
Procedure— Proceed as directed for Procedurein the test for Chromatographic purityunder Vancomycin Hydrochloride.Calculate the percentage of vancomycin Bin the specimen taken by the formula:
2500rB/(25rB+rA),
in which the terms are as defined therein:not less than 92%of vancomycin Bis found.
Calculate the percentage of any individual peak,other than the main peak,by the formula:
100rAi/(25rB+rA),
in which the terms are as defined therein:not more than 3%of any peak other than the main peak is found.
Assay— Proceed as directed for Vancomycin under Antibiotics—Microbial á81ñ,preparing the Test Dilutionas follows.Transfer about 100mg of Vancomycin,accurately weighed,to a 100-mLvolumetric flask.Add about 50mLof water and 1mLof 0.1Nhydrochloric acid,and swirl to dissolve,using sonication if necessary.Dilute with water to volume,and mix.Dilute an accurately measured portion of this stock solution quantitatively with Buffer No.4to yield a Test Dilutionhaving a concentration assumed to be equal to that of the median dose of the Standard.
Auxiliary Information— Staff Liaison:William W.Wright,Ph.D.,Scientific Fellow
Expert Committee:(PA7)Pharmaceutical Analysis 7
USP28–NF23Page 2013
Pharmacopeial Forum:Volume No.27(4)Page 2783
Phone Number:1-301-816-8335
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