﻿{"id":30993,"date":"2025-11-12T16:44:24","date_gmt":"2025-11-12T09:44:24","guid":{"rendered":"https:\/\/nhathuocngocanh.com\/bp\/?p=30993"},"modified":"2025-11-12T16:44:24","modified_gmt":"2025-11-12T09:44:24","slug":"vancomycin-hydrochloride","status":"publish","type":"post","link":"https:\/\/nhathuocngocanh.com\/bp\/vancomycin-hydrochloride\/","title":{"rendered":"Vancomycin Hydrochloride"},"content":{"rendered":"<p>Edition: BP 2025 (Ph. Eur. 11.6 update)<\/p>\n<p><strong>Action and use <\/strong><\/p>\n<p>Glycopeptide antibacterial.<\/p>\n<p><strong>Preparations<\/strong><\/p>\n<p>Vancomycin Capsules<\/p>\n<p>Vancomycin Eye Drops<\/p>\n<p>Vancomycin Infusion<\/p>\n<p>Vancomycin Oral Solution<\/p>\n<h2>DEFINITION<\/h2>\n<p>Monohydrochloride of (3S,6R,7R,8M,18M,22R,23S,26S,30aM,36R,38aR)-3-(2-amino-2-oxoethyl)-44-[[2-O-(3-amino-2,3,6- trideoxy-3-C-methyl-\u03b1-L-lyxo-hexopyranosyl)-\u03b2-D-glucopyranosyl]oxy]-10,19-dichloro-7,22,28,30,32-pentahydroxy-6-[(2R)-4-methyl-2-(methylamino)pentanamido]-2,5,24,38,39-pentaoxo-2,3,4,5,6,7,23,24,25,26,36,37,38,38a- tetradecahydro-22H-23,36-(azanomethano)-8,11:18,21-dietheno-13,16:31,35-dimetheno-1H,13H-[1,6,9]oxadiazacyclohexadecino[4,5-m][10,2,16]benzoxadiazacyclotetracosine-26-carboxylic acid (vancomycin B hydrochloride).<\/p>\n<p>Substance produced by certain strains of Amycolatopsis orientalis.<\/p>\n<p><strong>Potency<\/strong><\/p>\n<p>Minimum 1050 IU\/mg (anhydrous substance).<\/p>\n<h2>CHARACTERS<\/h2>\n<h3>Appearance<\/h3>\n<p>White or almost white, very hygroscopic powder.<\/p>\n<h3>Solubility<\/h3>\n<p>Freely soluble in water, practically insoluble in ethanol (96 per cent).<\/p>\n<h2>IDENTIFICATION<\/h2>\n<p>A. Examine the chromatograms obtained in the test for vancomycin B and related substances.<\/p>\n<p>Results The principal peak in the chromatogram obtained with the test solution is similar in retention time to the principal peak in the chromatogram obtained with reference solution (a).<\/p>\n<p>B. It gives reaction (a) of chlorides (2.3.1).<\/p>\n<h2>TESTS<\/h2>\n<h3>Appearance of solution<\/h3>\n<p>The solution is clear (2.2.1) and its absorbance (2.2.25) at 450 nm is not greater than 0.10, and its absorbance at 370 nm is not greater than 0.65.<\/p>\n<p>Dissolve 2.50 g in water R and dilute to 25.0 mL with the same solvent.<\/p>\n<p><strong>pH (2.2.3)<\/strong><\/p>\n<p>2.5 to 4.5.<\/p>\n<p>Dissolve 0.50 g in carbon dioxide-free water R and dilute to 10 mL with the same solvent.<\/p>\n<h3>Vancomycin B and related substances<\/h3>\n<p>Liquid chromatography (2.2.29): use the normalisation procedure.<\/p>\n<p>Solution A\u00a0 Dissolve 7.0 g of tris(hydroxymethyl)aminomethane R in approximately 950 mL of water for chromatography R. Measure the temperature of the solution. Considering the temperature dependency of the buffer, adjust the pH to 8.0-8.3 using a 20 per cent V\/V solution of glacial acetic acid R in water for chromatography R and dilute to 1000 mL with water for chromatography R.<\/p>\n<p>Test solution\u00a0 Dissolve 20.0 mg of the substance to be examined in water R and dilute to 5.0 mL with the same solvent.<\/p>\n<p>Reference solution (a) Dissolve 6 mg of vancomycin for system suitability CRS (containing impurities A, C, F, H, I, J, K and M) in 1.5 mL of water R.<\/p>\n<p>Reference solution (b) In order to prepare impurities B, D, E, G and L in situ, expose 4 mg of vancomycin for system suitability CRS (containing impurities A, C, F, H, I, J, K and M) to 80-100 per cent relative humidity at 42 \u00b1 2 \u00b0C for at least 7 days. Add 1 mL of water R and dissolve the sample completely using sonication.<\/p>\n<p>Reference solution (c) Dilute 1.0 mL of reference solution (a) to 100.0 mL with a 0.1 per cent V\/V solution of acetic acid R. Dilute 1.0 mL of this solution to 10.0 mL with a 0.1 per cent V\/V solution of acetic acid R.<\/p>\n<p>Column:<\/p>\n<p>\u2014 size: l = 0.15 m, \u00d8 = 2.1 mm;<\/p>\n<p>\u2014 stationary phase: end-capped, charged surface, ethylene-bridged octadecylsilyl silica gel for chromatography\u00a0(hybrid material) R (1.7 \u00b5m);<\/p>\n<p>\u2014 temperature: 40 \u00b1 2 \u00b0C.<\/p>\n<p>Mobile phase:<\/p>\n<p>\u2014 mobile phase A: acetonitrile R, methanol R, solution A (3:4:93 V\/V\/V);<\/p>\n<p>\u2014 mobile phase B: acetonitrile R, methanol R, solution A (10:40:50 V\/V\/V);<\/p>\n<table style=\"border-collapse: collapse; width: 100%; height: 106px;\">\n<tbody>\n<tr style=\"height: 21px;\">\n<td style=\"width: 33.3333%; height: 21px; text-align: center;\"><strong>Time (min)<\/strong><\/td>\n<td style=\"width: 33.3333%; height: 21px; text-align: center;\"><strong>Mobile phase A (per cent V\/V)<\/strong><\/td>\n<td style=\"width: 33.3333%; height: 21px; text-align: center;\"><strong>Mobile phase B (per cent V\/V)<\/strong><\/td>\n<\/tr>\n<tr style=\"height: 21px;\">\n<td style=\"width: 33.3333%; height: 21px; text-align: center;\">0 &#8211; 7<\/td>\n<td style=\"width: 33.3333%; height: 21px; text-align: center;\">88<\/td>\n<td style=\"width: 33.3333%; height: 21px; text-align: center;\">12<\/td>\n<\/tr>\n<tr style=\"height: 21px;\">\n<td style=\"width: 33.3333%; height: 21px; text-align: center;\">7 &#8211; 21<\/td>\n<td style=\"width: 33.3333%; height: 21px; text-align: center;\">88 \u2192 75<\/td>\n<td style=\"width: 33.3333%; height: 21px; text-align: center;\">12 \u2192 25<\/td>\n<\/tr>\n<tr style=\"height: 22px;\">\n<td style=\"width: 33.3333%; height: 22px; text-align: center;\">21 &#8211; 35<\/td>\n<td style=\"width: 33.3333%; height: 22px; text-align: center;\">75 \u2192 25<\/td>\n<td style=\"width: 33.3333%; height: 22px; text-align: center;\">25 \u2192 75<\/td>\n<\/tr>\n<tr style=\"height: 21px;\">\n<td style=\"width: 33.3333%; height: 21px; text-align: center;\">35 &#8211; 37<\/td>\n<td style=\"width: 33.3333%; height: 21px; text-align: center;\">25<\/td>\n<td style=\"width: 33.3333%; height: 21px; text-align: center;\">75<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>Flow rate\u00a0 0.30 \u00b1 0.02 mL\/min.<\/p>\n<p>Detection\u00a0 Spectrophotometer at 280 nm.<\/p>\n<p>Autosampler\u00a0 Set at 5 \u00b0C.<\/p>\n<p>Injection\u00a0 2 \u00b5L.<\/p>\n<p>Identification of peaks\u00a0 Use the chromatogram obtained with reference solution (a) to identify the peaks due to impurities A, C, F, H, I, J, K and M; use the chromatogram obtained with reference solution (b) to identify the peaks due to impurities B, D, E, G and L.<\/p>\n<p>Relative retention\u00a0 With reference to vancomycin B (retention time = about 19 min): impurity E = about 0.37; impurity L = about 0.66; impurity B = about 0.70; impurity A = about 0.76; impurity F = about 0.82; impurity G = about 0.90; impurity H = about 0.94; impurity M = about 1.11; impurity I = about 1.14; impurity J = about 1.20; impurity D = about 1.24; impurity K = about 1.50; impurity C = about 1.86.<\/p>\n<p>System suitability:<\/p>\n<p>\u2014 resolution: minimum 1.5 and maximum 4.0 between the peaks due to impurities G and H, and minimum 1.5 and maximum 5.0 between the peaks due to impurities L and B in the chromatogram obtained with reference solution (b). If the resolution between the peaks due to impurities G and H is greater than 4.0, adjust the pH of solution A to a higher value. If the resolution between the peaks due to impurities L and B is greater than 5.0, adjust the pH of solution A to a lower value;<\/p>\n<p>\u2014 signal-to-noise ratio: minimum 10 for the peak due to vancomycin B in the chromatogram obtained with reference solution (c).<\/p>\n<p>Limits:<\/p>\n<p>\u2014 vancomycin B: minimum 91.0 per cent;<\/p>\n<p>\u2014 impurities A, H: for each impurity, maximum 3.0 per cent;<\/p>\n<p>\u2014 sum of impurities B and E: maximum 2.0 per cent;<\/p>\n<p>\u2014 impurity J: maximum 1.6 per cent;<\/p>\n<p>\u2014 impurities D, F, M: for each impurity, maximum 1.5 per cent;<\/p>\n<p>\u2014 impurities G, I, K: for each impurity, maximum 1.2 per cent;<\/p>\n<p>\u2014 impurity C: maximum 1.0 per cent;<\/p>\n<p>\u2014 any other impurity eluting before vancomycin B: for each impurity, maximum 0.8 per cent, and not more than 5 such impurities exceed 0.30 per cent;<\/p>\n<p>\u2014 any other impurity eluting after vancomycin B: for each impurity, maximum 0.8 per cent, and not more than 3 such impurities exceed 0.30 per cent;<\/p>\n<p>\u2014 total of impurities: maximum 9.0 per cent;<\/p>\n<p>\u2014 reporting threshold: 0.10 per cent.<\/p>\n<p><strong>Water (2.5.12)<\/strong><\/p>\n<p>Maximum 5.0 per cent, determined on 0.500 g.<\/p>\n<p><strong>Sulfated ash (2.4.14)<\/strong><\/p>\n<p>Maximum 1.0 per cent, determined on 1.00 g.<\/p>\n<h2>ASSAY<\/h2>\n<p>Carry out the microbiological assay of antibiotics (2.7.2). Use vancomycin hydrochloride CRS as the reference substance.<\/p>\n<h2>STORAGE<\/h2>\n<p>In an airtight container, protected from light at a temperature of 2 \u00b0C to 8 \u00b0C. If the substance is sterile, the container is also sterile and tamper-evident.<\/p>\n<h2>LABELLING<\/h2>\n<p>The label states, where applicable, that the substance is suitable for use in the manufacture of parenteral preparations.<\/p>\n<h2>IMPURITIES<\/h2>\n<p><em>Specified impurities\u00a0 A, B, C, D, E, F, G, H, I, J, K, M.<\/em><\/p>\n<p><em>Other detectable impurities (the following substances would, if present at a sufficient level, be detected by one or other of the tests in the monograph. They are limited by the general acceptance criterion for other\/unspecified impurities. It is therefore not necessary to identify these impurities for demonstration of compliance. See also 5.10. Control of impurities in substances for pharmaceutical use) L.<\/em><\/p>\n<p>A. N2.1-demethylvancomycin B,<\/p>\n<p>B. (1.2M)-[L-\u03b2-Asp3]vancomycin B (3.2-syn-chloro[L-\u03b2-Asp3]vancomycin B) (CDP-1 major),<\/p>\n<p>C. O4.4-de-[2-O-(3-amino-2,3,6-trideoxy-3-C-methyl-\u03b1-L-lyxo-hexopyranosyl)-\u03b2-D-glucopyranosyl]vancomycin B (aglucovancomycin B),<\/p>\n<p>D. O4.4-de-[2-O-(3-amino-2,3,6-trideoxy-3-C-methyl-\u03b1-L-lyxo-hexopyranosyl)-\u03b2-D-glucopyranosyl]-O4.4-\u03b2-D- glucopyranosyl-vancomycin B (desvancosaminylvancomycin B),<\/p>\n<p>E. [L-\u03b2-Asp3]vancomycin B (CDP-1 minor),<\/p>\n<p>F. [L-\u03b1-Gln3]vancomycin B,<\/p>\n<p>G. 4.3,N\u03b1,4-anhydro-[L-\u03b1-Asp3]vancomycin B,<\/p>\n<p>H. 3.6-dechlorovancomycin B (mono-dechloro-6-vancomycin B),<\/p>\n<p>I. (1.2M)-vancomycin B (3.2-syn-chloro-vancomycin B),<\/p>\n<p>J. (C\u03b1,7R)-vancomycin B (26-epi-vancomycin B),<\/p>\n<p>K. [N,N-dimethyl-D-Leu1]vancomycin B,<\/p>\n<p>L. [L-\u03b1-Asp3]vancomycin B),<\/p>\n<p>M. unknown structure.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Edition: BP 2025 (Ph. Eur. 11.6 update) Action and use Glycopeptide antibacterial. Preparations Vancomycin Capsules Vancomycin Eye Drops Vancomycin Infusion Vancomycin Oral Solution DEFINITION Monohydrochloride of (3S,6R,7R,8M,18M,22R,23S,26S,30aM,36R,38aR)-3-(2-amino-2-oxoethyl)-44-[[2-O-(3-amino-2,3,6- trideoxy-3-C-methyl-\u03b1-L-lyxo-hexopyranosyl)-\u03b2-D-glucopyranosyl]oxy]-10,19-dichloro-7,22,28,30,32-pentahydroxy-6-[(2R)-4-methyl-2-(methylamino)pentanamido]-2,5,24,38,39-pentaoxo-2,3,4,5,6,7,23,24,25,26,36,37,38,38a- tetradecahydro-22H-23,36-(azanomethano)-8,11:18,21-dietheno-13,16:31,35-dimetheno-1H,13H-[1,6,9]oxadiazacyclohexadecino[4,5-m][10,2,16]benzoxadiazacyclotetracosine-26-carboxylic acid (vancomycin B hydrochloride). Substance produced by certain strains of Amycolatopsis orientalis. Potency Minimum 1050 IU\/mg (anhydrous substance). CHARACTERS Appearance White or almost white, very hygroscopic&#8230;<\/p>\n","protected":false},"author":5,"featured_media":30994,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[174],"tags":[],"class_list":["post-30993","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-medicinal-substances"],"acf":[],"_links":{"self":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/30993","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/users\/5"}],"replies":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/comments?post=30993"}],"version-history":[{"count":2,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/30993\/revisions"}],"predecessor-version":[{"id":31014,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/30993\/revisions\/31014"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/30994"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=30993"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=30993"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=30993"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}