General Notices\u00a0<\/strong><\/p>\n (Ph. Eur. monograph 0210)<\/p>\n C22<\/sub>H25<\/sub>ClN2<\/sub>O8<\/sub>\u2003 480.9\u2003 64-75-5<\/p>\n Action and use\u00a0<\/strong><\/p>\n Tetracycline antibacterial.<\/p>\n Preparations<\/p>\n Tetracycline Capsules<\/p>\n Tetracycline Tablets<\/p>\n Ph Eur<\/p>\n (4S,4aS,5aS,6S,12aS)-4-(Dimethylamino)-3,6,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-1,4,4a,5,5a,6,11,12a octahydrotetracene-2-carboxamide hydrochloride.<\/p>\n Substance produced by certain strains of Streptomyces aerofaciens or obtained by any other means.<\/p>\n Content\u00a0<\/strong><\/p>\n 95.0 per cent to 102.0 per cent (dried substance).<\/p>\n Appearance\u00a0<\/strong><\/p>\n Yellow, crystalline powder.<\/p>\n Solubility\u00a0<\/strong><\/p>\n Soluble in water, slightly soluble in ethanol (96 per cent), practically insoluble in acetone. It dissolves in solutions of alkali hydroxides and carbonates. Solutions in water become turbid on standing, owing to the precipitation of tetracycline.<\/p>\n A.\u2003Thin-layer chromatography (2.2.27).<\/p>\n Test solution Dissolve 5 mg of the substance to be examined in methanol R and dilute to 10 mL with the same solvent.<\/p>\n Reference solution (a) Dissolve 5 mg of tetracycline hydrochloride CRS in methanol R and dilute to 10 mL with the same solvent.<\/p>\n Reference solution (b) Dissolve 5 mg of tetracycline hydrochloride CRS, 5 mg of demeclocycline hydrochloride R and 5 mg of oxytetracycline hydrochloride R in methanol R and dilute to 10 mL with the same solvent.<\/p>\n Plate TLC octadecylsilyl silica gel F254 plate R.<\/p>\n Mobile phase Mix 20 volumes of acetonitrile R, 20 volumes of methanol R and 60 volumes of a 63 g\/L solution of oxalic acid R previously adjusted to pH 2 with concentrated ammonia R.<\/p>\n Application 1 \u00b5L.<\/p>\n Development Over 3\/4 of the plate.<\/p>\n Drying In air.<\/p>\n Detection Examine in ultraviolet light at 254 nm.<\/p>\n System suitability The chromatogram obtained with reference solution (b) shows 3 clearly separated spots.<\/p>\n Results The principal spot in the chromatogram obtained with the test solution is similar in position and size to the principal spot in the chromatogram obtained with reference solution (a).<\/p>\n B.\u2003To about 2 mg add 5 mL of sulfuric acid R. A violet-red colour develops. Add the solution to 2.5 mL of water R. The colour becomes yellow.<\/p>\n C.\u2003It gives reaction (a) of chlorides (2.3.1).<\/p>\n 1.8 to 2.8.<\/p>\n Dissolve 0.1 g in 10 mL of carbon dioxide-free water R.<\/p>\n Specific optical rotation (2.2.7)<\/p>\n -240 to -255 (dried substance).<\/p>\n Dissolve 0.250 g in 0.1 M hydrochloric acid and dilute to 25.0 mL with the same acid.<\/p>\n Liquid chromatography (2.2.29). Prepare the solutions immediately before use.<\/p>\n Test solution Dissolve 25.0 mg of the substance to be examined in 0.01 M hydrochloric acid and dilute to 25.0 mL with the same acid.<\/p>\n Reference solution (a) Dissolve 25.0 mg of tetracycline hydrochloride CRS in 0.01 M hydrochloric acid and dilute to 25.0 mL with the same acid.<\/p>\n Reference solution (b) Dissolve 15.0 mg of 4-epitetracycline hydrochloride CRS in 0.01 M hydrochloric acid and dilute to 50.0 mL with the same acid.<\/p>\n Reference solution (c) Dissolve 10.0 mg of anhydrotetracycline hydrochloride CRS in 0.01 M hydrochloric acid and dilute to 100.0 mL with the same acid.<\/p>\n Reference solution (d) Dissolve 10.0 mg of 4-epianhydrotetracycline hydrochloride CRS in 0.01 M hydrochloric acid and dilute to 50.0 mL with the same acid.<\/p>\n Reference solution (e) Mix 1.0 mL of reference solution (a), 2.0 mL of reference solution (b) and 5.0 mL of reference solution (d) and dilute to 25.0 mL with 0.01 M hydrochloric acid.<\/p>\n Reference solution (f) Mix 20.0 mL of reference solution (b), 10.0 mL of reference solution (c) and 5.0 mL of reference solution (d) and dilute to 200.0 mL using 0.01 M hydrochloric acid.<\/p>\n Reference solution (g) Dilute 1.0 mL of reference solution (c) to 50.0 mL with 0.01 M hydrochloric acid. Column:<\/p>\n \u2014 size: l = 0.25 m, \u00d8 = 4.6 mm;<\/p>\n \u2014 stationary phase: styrene-divinylbenzene copolymer R (8 \u00b5m);<\/p>\n \u2014 temperature: 60 \u00b0C.<\/p>\n Mobile phase Weigh 80.0 g of 2-methyl-2-propanol R and transfer to a 1000 mL volumetric flask with the aid of 200 mL of water R; add 100 mL of a 35 g\/L solution of dipotassium hydrogen phosphate R adjusted to pH 9.0 with dilute phosphoric acid R, 200 mL of a 10 g\/L solution of tetrabutylammonium hydrogen sulfate R adjusted to pH 9.0 with dilute sodium hydroxide solution R and 10 mL of a 40 g\/L solution of sodium edetate R adjusted to pH 9.0 with dilute sodium hydroxide solution R; dilute to 1000.0 mL with water R.<\/p>\n Flow rate 1.0 mL\/min.<\/p>\n Detection Spectrophotometer at 254 nm.<\/p>\n Injection 20 \u00b5L; inject the test solution and reference solutions (e), (f) and (g).<\/p>\n System suitability:<\/p>\n st nd<\/p>\n \u2014 resolution: minimum 2.5 between the peaks due to impurity A (1 peak) and tetracycline (2 peak) and rd<\/p>\n minimum 8.0 between the peaks due to tetracycline and impurity D (3 peak) in the chromatogram obtained with reference solution (e); if necessary, adjust the concentration of 2-methyl-2-propanol in the mobile phase;<\/p>\n \u2014 signal-to-noise ratio: minimum 3 for the principal peak in the chromatogram obtained with reference solution (g);<\/p>\n \u2014 symmetry factor: maximum 1.25 for the peak due to tetracycline in the chromatogram obtained with reference solution (e).<\/p>\n Limits:<\/p>\n \u2014 impurity A: not more than the area of the corresponding peak in the chromatogram obtained with reference solution (f) (3.0 per cent);<\/p>\n \u2014 impurity B (eluting on the tail of the principal peak): not more than 0.5 times the area of the peak due to impurity A in the chromatogram obtained with reference solution (f) (1.5 per cent);<\/p>\n \u2014 impurity C: not more than the area of the corresponding peak in the chromatogram obtained with reference solution (f) (0.5 per cent);<\/p>\n \u2014 impurity D: not more than the area of the corresponding peak in the chromatogram obtained with reference solution (f) (0.5 per cent).<\/p>\n Maximum 2.0 per cent, determined on 1.000 g by drying in vacuo at 60 \u00b0C at a pressure not exceeding 0.7 kPa for 3 h.<\/p>\n Maximum 0.5 per cent, determined on 1.0 g.<\/p>\n Less than 0.5 IU\/mg, if intended for use in the manufacture of parenteral preparations without a further appropriate procedure for the removal of bacterial endotoxins.<\/p>\n Liquid chromatography (2.2.29) as described in the test for related substances with the following modification. Injection Test solution and reference solution (a).<\/p>\n Calculate the percentage content of C22<\/sub>H25<\/sub>ClN2<\/sub>O8<\/sub>.<\/p>\n Protected from light. If the substance is sterile, store in a sterile, tamper-evident container.<\/p>\n \u200b<\/span><\/p>\n \u200b<\/span><\/p>\n \u200b<\/span><\/p>\n \u200b\u200b\u200b\u200b\u200b<\/p>\n Edition: BP 2025 (Ph. Eur. 11.6 update) Tetracycline Hydrochloride \u200b General Notices\u00a0 (Ph. Eur. monograph 0210) C22H25ClN2O8\u2003 480.9\u2003 64-75-5 Action and use\u00a0 Tetracycline antibacterial. Preparations Tetracycline Capsules Tetracycline Tablets Ph Eur DEFINITION (4S,4aS,5aS,6S,12aS)-4-(Dimethylamino)-3,6,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-1,4,4a,5,5a,6,11,12a octahydrotetracene-2-carboxamide hydrochloride. Substance produced by certain strains of Streptomyces aerofaciens or obtained by any other means. Content\u00a0 95.0 per cent to 102.0…<\/p>\n","protected":false},"author":5,"featured_media":29679,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[174],"tags":[],"class_list":["post-29672","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\/29672","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=29672"}],"version-history":[{"count":2,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/29672\/revisions"}],"predecessor-version":[{"id":29681,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/29672\/revisions\/29681"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/29679"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=29672"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=29672"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=29672"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}DEFINITION<\/h2>\n
CHARACTERS<\/h2>\n
IDENTIFICATION<\/h2>\n
TESTS<\/h2>\n
pH (2.2.3)<\/h3>\n
Related substances<\/h3>\n
Loss on drying (2.2.32)<\/h3>\n
Sulfated ash (2.4.14)<\/h3>\n
Bacterial endotoxins (2.6.14)<\/h3>\n
ASSAY<\/h2>\n
STORAGE<\/h2>\n
IMPURITIES<\/h2>\n
![\"A.\u2003(4R,4aS,5aS,6S,12aS)-4-(dimethylamino)-3,6,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-1,4,4a,5,5a,6,11,12a](\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/Tetracycline-Hydrochloride-2.jpg\")
![\"B.\u2003(4S,4aS,5aS,6S,12aS)-2-acetyl-4-(dimethylamino)-3,6,10,12,12a-pentahydroxy-6-methyl-4a,5a,6,12a](\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/Tetracycline-Hydrochloride-3.jpg\")
![\"C.\u2003(4S,4aS,12aS)-4-(dimethylamino)-3,10,11,12a-tetrahydroxy-6-methyl-1,12-dioxo-1,4,4a,5,12,12a-hexahydrotetracene](\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/Tetracycline-Hydrochloride-4.jpg\")
![\"D.\u2003(4R,4aS,12aS)-4-(dimethylamino)-3,10,11,12a-tetrahydroxy-6-methyl-1,12-dioxo-1,4,4a,5,12,12a](\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/Tetracycline-Hydrochloride-5.jpg\")