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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--L-lyxo-hexopyranosyl)--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--L-lyxo-hexopyranosyl)-- 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 950 µg of vancomycin per mg, calculated on the anhydrous basis.
Packaging and storage— Preserve in tight containers.
B: It does not respond to the test for Chloride 191.
Water, Method I 921: not more than 20%.
Heavy metals, Method II 231: 0.003%.
Chromatographic purity—
Triethylamine buffer, Solution A, Solution B, Mobile Phase, Resolution solution, and Chromatographic system —Prepare as directed in the test for Chromatographic purity under Vancomycin Hydrochloride.
Test preparation A— Transfer about 250 mg of Vancomycin to a 25-mL volumetric flask, add 5 mL of Mobile phase A, then add 0.1 N hydrochloric acid dropwise with swirling until dissolution is achieved. Dilute with Mobile phase A to volume, and mix.
Test preparation B— Transfer 2.0 mL of Test preparation A to a 50-mL volumetric flask, dilute with Mobile phase A to volume, and mix.
Procedure— Proceed as directed for Procedure in the test for Chromatographic purity under Vancomycin Hydrochloride. Calculate the percentage of vancomycin B in the specimen taken by the formula:
2500rB / (25rB + r A),
in which the terms are as defined therein: not less than 92% of vancomycin B is 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.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
Assay— Proceed as directed for Vancomycin under Antibiotics—Microbial 81, preparing the Test Dilution as follows. Transfer about 100 mg of Vancomycin, accurately weighed, to a 100-mL volumetric flask. Add about 50 mL of water and 1 mL of 0.1 N hydrochloric 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. 4 to yield a Test Dilution having a concentration assumed to be equal to that of the median dose of the Standard.
Auxiliary Information— Staff Liaison : Brian D. Gilbert, Ph.D., Scientist
Expert Committee : (MDANT05) Monograph Development-Antibiotics
USP29–NF24 Page 2238
Pharmacopeial Forum : Volume No. 30(6) Page 2055
Phone Number : 1-301-816-8223