{"id":28890,"date":"2025-11-10T08:51:25","date_gmt":"2025-11-10T01:51:25","guid":{"rendered":"https:\/\/nhathuocngocanh.com\/bp\/?p=28890"},"modified":"2025-11-10T08:51:25","modified_gmt":"2025-11-10T01:51:25","slug":"teicoplanin","status":"publish","type":"post","link":"https:\/\/nhathuocngocanh.com\/bp\/teicoplanin\/","title":{"rendered":"Teicoplanin"},"content":{"rendered":"

Edition: BP 2025 (Ph. Eur. 11.6 update)<\/p>\n

General Notices<\/p>\n

(Ph. Eur. monograph 2358)<\/p>\n

\"\"<\/p>\n

\"61036-62-2\"
61036-62-2<\/figcaption><\/figure>\n

Action and use<\/strong><\/p>\n

Glycopeptide antibacterial.<\/p>\n

Preparation<\/p>\n

Teicoplanin for Injection<\/p>\n

Ph Eur<\/p>\n

DEFINITION<\/h2>\n

Mixture of glycopeptides produced by certain strains of Actinoplanes teichomyceticus sp.; the 6 principal components of the mixture are teicoplanins A2-1 to A2-5 and teicoplanin A3-1, and 2 minor components are teicoplanins A2-1a and A2-1b.<\/p>\n

Fermentation product.<\/p>\n

Potency: Minimum 900 IU\/mg (anhydrous and sodium chloride-free substance).<\/p>\n

CHARACTERS<\/h2>\n

Appearance<\/h3>\n

White or yellowish, amorphous powder.<\/p>\n

Solubility<\/h3>\n

Freely soluble in water, sparingly soluble in dimethylformamide, practically insoluble in ethanol (96 per cent).<\/p>\n

IDENTIFICATION<\/h2>\n

A. Infrared absorption spectrophotometry (2.2.24).
\nComparison: teicoplanin for identification CRS.<\/p>\n

B. Examine the chromatograms obtained in the test for composition.<\/p>\n

Results: The principal peaks (teicoplanins A3-1, A2-1, A2-2, A2-3, A2-4 and A2-5) and the 2 minor peaks (A2-1a and A2-1b) in the chromatogram obtained with the test solution are similar in retention time and size to the principal peaks in the chromatogram obtained with reference solution (a).<\/p>\n

TESTS<\/h2>\n

Appearance of solution:<\/h3>\n

The solution is clear (2.2.1) and not more intensely coloured than reference solution BY3 or B4 (2.2.2, Method I).<\/p>\n

Dissolve 0.8 g in 10 mL of water R.<\/p>\n

pH (2.2.3): 6.5 to 7.5.<\/p>\n

Dissolve 0.50 g in carbon dioxide-free water R and dilute to 10 mL with the same solvent.<\/p>\n

Composition:<\/h3>\n

Liquid chromatography (2.2.29); use the normalisation procedure.<\/p>\n

Test solution: Dissolve 0.100 g of the substance to be examined in water R and dilute to 50.0 mL with the same solvent.<\/p>\n

Reference solution (a): Dissolve 20 mg of teicoplanin for identification CRS in water R and dilute to 10.0 mL with the same solvent.<\/p>\n

Reference solution (b): Dilute 1.0 mL of reference solution (a) to 10.0 mL with water R. Dilute 1.0 mL of this solution to 20.0 mL with water R.<\/p>\n

Reference solution (c): Dissolve 50.0 mg of mesityl oxide CRS (impurity A) in water R and dilute to 25.0 mL with the same solvent. Dilute 1.0 mL of this solution to 10.0 mL with water R. Dilute 1.0 mL of this solution to 100.0 mL with water R.<\/p>\n

Column:
\n\u2014 size: l = 0.25 m, \u00d8 = 4.6 mm;
\n\u2014 stationary phase: spherical end-capped octadecylsilyl silica gel for chromatography R (5 \u03bcm).<\/p>\n

Mobile phase:
\n\u2014 mobile phase A: mix 900 mL of a 3.0 g\/L solution of anhydrous sodium dihydrogen phosphate R, adjusted to pH 6.0 with a 40 g\/L solution of sodium hydroxide R, and 100 mL of acetonitrile R;
\n\u2014 mobile phase B: mix 300 mL of the same buffer and 700 mL of acetonitrile R.<\/p>\n\n\n\n\n\n\n
Time (min)<\/td>\nMobile phase A (%)<\/td>\nMobile phase B (%)<\/td>\n<\/tr>\n
0 – 30<\/td>\n100 \u2192 50<\/td>\n0 \u2192 50<\/td>\n<\/tr>\n
30 \u2013 31<\/td>\n50 \u2192 10<\/td>\n50 \u2192 90<\/td>\n<\/tr>\n
31 \u2013 35<\/td>\n10<\/td>\n90<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

Flow rate: 2.3 mL\/min.<\/p>\n

Detection: Spectrophotometer at 254 nm.<\/p>\n

Injection: 20 \u03bcL of the test solution and reference solutions (a) and (b).<\/p>\n

Identification:<\/p>\n

Use the chromatogram supplied with teicoplanin for identification CRS and the chromatogram obtained with reference solution (a) to identify the groups and components.<\/p>\n

Relative retention: With reference to teicoplanin A2-2 (retention time \u2248 18 min):<\/p>\n

\u2014 Teicoplanin A3 group \u2264 0.70:
\n\u2014 Teicoplanin A3-1 = about 0.43.<\/p>\n

\u2014 Teicoplanin A2 group > 0.70 including:
\n\u2014 Teicoplanin A2-1 group > 0.70 and < 1.00:
\n\u2014 Teicoplanin A2-1a = about 0.85;
\n\u2014 Teicoplanin A2-1b = about 0.88;
\n\u2014 Teicoplanin A2-1 = about 0.93.<\/p>\n

\u2014 Teicoplanin A2-2 = 1.00.<\/p>\n

\u2014 Teicoplanin A2-3 group > 1.00 and < 1.12:
\n\u2014 Teicoplanin A2-3 = about 1.03;
\n\u2014 Teicoplanin A2-4 = about 1.12.<\/p>\n

\u2014 Teicoplanin A2-5 group > 1.12 and < 1.25:
\n\u2014 Teicoplanin A2-5 = about 1.15.<\/p>\n

\u2014 Teicoplanin A2-6 group \u2265 1.25:
\n\u2014 Teicoplanin-like related substance RS A2-6a = about 1.25;
\n\u2014 Teicoplanin-like related substance RS A2-6b = about 1.30;
\n\u2014 Teicoplanin-like related substance RS A2-6c = about 1.38.<\/p>\n

System suitability:<\/p>\n

\u2014 The chromatogram obtained with reference solution (a) is similar to that supplied with teicoplanin for identification CRS.
\n\u2014 Resolution: minimum 1.0 between peaks due to A2-4 and A2-5 (reference a).
\n\u2014 Signal-to-noise ratio: minimum 40 for A2-2 (reference b).<\/p>\n

\"\"<\/p>\n

S2 = sum of the areas of the peaks due to teicoplanin A2 group in the chromatogram obtained with the test solution.<\/p>\n

S3 = sum of the areas of the peaks due to teicoplanin A3 group in the chromatogram obtained with the test solution; disregard any peak due to impurity A.<\/p>\n

S2-6 = sum of the areas of the peaks with a relative retention greater than or equal to 1.25 in the chromatogram obtained with the test solution.<\/p>\n

S2-1 = sum of the areas of the peaks due to teicoplanin A2-1 group in the chromatogram obtained with the test solution.<\/p>\n

A2-1a = area of the peak due to teicoplanin A2-1a in the chromatogram obtained with the test solution.<\/p>\n

A2-1b = area of the peak due to teicoplanin A2-1b in the chromatogram obtained with the test solution.<\/p>\n

A2-1 = area of the peak due to teicoplanin A2-1 in the chromatogram obtained with the test solution.<\/p>\n

A2-2 = area of the peak due to teicoplanin A2-2 in the chromatogram obtained with the test solution.<\/p>\n

S2-3 = sum of the areas of the peaks due to teicoplanin A2-3 group in the chromatogram obtained with the test solution.<\/p>\n

A2-3 = area of the peak due to teicoplanin A2-3 in the chromatogram obtained with the test solution.<\/p>\n

A2-4 = area of the peak due to teicoplanin A2-4 in the chromatogram obtained with the test solution.<\/p>\n

S2-5 = sum of the areas of the peaks due to teicoplanin A2-5 group in the chromatogram obtained with the test solution.<\/p>\n

A2-5 = area of the peak due to teicoplanin A2-5 in the chromatogram obtained with the test solution.<\/p>\n

Limits<\/p>\n

\u2014 Teicoplanin A2 group: 84.0 % \u2013 98.0 %.
\n\u2014 Teicoplanin A2-2: 37.0 % \u2013 50.0 %.
\n\u2014 Teicoplanin A2-1 group: 10.0 % \u2013 19.0 %.
\n\u2014 Teicoplanin A2-5 group: 7.0 % \u2013 17.0 %.
\n\u2014 Teicoplanin A2-4: 7.0 % \u2013 15.0 %.
\n\u2014 Teicoplanin A2-5: 7.0 % \u2013 15.0 %.
\n\u2014 Teicoplanin A2-3 group: 5.0 % \u2013 11.0 %.
\n\u2014 Teicoplanin A3 group: 4.0 % \u2013 12.0 %.
\n\u2014 Teicoplanin A2-3: 4.0 % \u2013 8.5 %.
\n\u2014 Teicoplanin A2-1: 2.0 % \u2013 7.0 %.
\n\u2014 Teicoplanin A2-1a: 0.5 % \u2013 5.5 %.
\n\u2014 Teicoplanin A2-1b: 0.5 % \u2013 4.0 %.
\n\u2014 Teicoplanin A2-6 group: \u2264 5.0 %.
\n\u2014 Disregard limit: 0.25 %.<\/p>\n

Related substances:<\/p>\n

Liquid chromatography (2.2.29) as described in the test for composition (normalisation procedure).<\/p>\n

Use the chromatogram obtained with reference solution (a) to identify all peaks present above the disregard limit as teicoplanin-like related substances. Any peak present in any part of the chromatogram obtained with the test solution that cannot be correlated to a peak above the disregard limit in reference solution (a) should be considered as a non-teicoplanin-like impurity, unless it is characterized by other means.<\/p>\n

A teicoplanin-like related substance is defined as a substance that shares the same glycopeptide core structure of the parent molecule, composed of a linear heptapeptide aglycone, an \u03b1-D-mannose and an acetyl-\u03b2-D-glucosamine. The R\u2032 side chains in the teicoplanin-like related substances RS A2-6a, RS A2-6b and RS A2-6c are unknown.<\/p>\n

Calculate the percentage contents using the following equations:<\/p>\n

\"\"<\/p>\n

Limits:<\/p>\n

\u2014 RS A2-6c: \u2264 2.5 %.
\n\u2014 RS A2-6a: \u2264 1.5 %.
\n\u2014 RS A2-6b: \u2264 1.5 %.
\n\u2014 Any non-teicoplanin-like impurity (other than A): \u2264 0.5 %.
\n\u2014 Total non-teicoplanin-like impurities (other than A): \u2264 1.5 %.<\/p>\n

Impurity A:<\/strong><\/p>\n

Liquid chromatography (2.2.29) as described in the test for composition, with the following modifications.<\/p>\n

Injection: 20 \u03bcL of the test solution and reference solution (c).<\/p>\n

Relative retention: With reference to A2-2 (retention \u2248 18 min): impurity A \u2248 0.6.<\/p>\n

Calculation of content: Use the concentration of impurity A in reference solution (c).<\/p>\n

Limit:<\/p>\n

\u2014 Impurity A \u2264 0.2 %.<\/p>\n

Chlorides:<\/strong><\/p>\n

Maximum 5.0 %, expressed as sodium chloride (anhydrous substance).<\/p>\n

Dissolve 1.000 g in 300 mL of water R, stir and acidify with 2 mL of nitric acid R.<\/p>\n

Titrate with 0.1 M silver nitrate, determining the end-point potentiometrically (2.2.20).<\/p>\n

1 mL of 0.1 M AgNO\u2083 \u2261 5.844 mg NaCl.<\/p>\n

Water (2.5.12): Maximum 15.0 % (on 0.300 g).<\/p>\n

ASSAY<\/h2>\n

Carry out the microbiological assay of antibiotics (2.7.2), using the diffusion method.<\/p>\n

Use teicoplanin CRS as the reference substance.<\/p>\n

STORAGE<\/h2>\n

Protected from light, at 2 \u00b0C to 8 \u00b0C.<\/p>\n

IMPURITIES<\/h2>\n

Specified impurity: A.<\/p>\n

\"A.
A. 4-methylpent-3-en-2-one (mesityl oxide).<\/figcaption><\/figure>\n","protected":false},"excerpt":{"rendered":"

Edition: BP 2025 (Ph. Eur. 11.6 update) General Notices (Ph. Eur. monograph 2358) Action and use Glycopeptide antibacterial. Preparation Teicoplanin for Injection Ph Eur DEFINITION Mixture of glycopeptides produced by certain strains of Actinoplanes teichomyceticus sp.; the 6 principal components of the mixture are teicoplanins A2-1 to A2-5 and teicoplanin A3-1, and 2 minor components…<\/p>\n","protected":false},"author":5,"featured_media":28892,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[174],"tags":[],"class_list":["post-28890","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\/28890","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=28890"}],"version-history":[{"count":1,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/28890\/revisions"}],"predecessor-version":[{"id":28902,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/28890\/revisions\/28902"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/28892"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=28890"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=28890"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=28890"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}