﻿{"id":29428,"date":"2025-11-10T16:50:47","date_gmt":"2025-11-10T09:50:47","guid":{"rendered":"https:\/\/nhathuocngocanh.com\/bp\/?p=29428"},"modified":"2025-11-10T16:50:47","modified_gmt":"2025-11-10T09:50:47","slug":"tetracosactide","status":"publish","type":"post","link":"https:\/\/nhathuocngocanh.com\/bp\/tetracosactide\/","title":{"rendered":"Tetracosactide"},"content":{"rendered":"<p>Edition: BP 2025 (Ph. Eur. 11.6 update)<\/p>\n<p>(Ph. Eur. monograph 0644)<\/p>\n<p>H\u2014Ser\u2014Tyr\u2014Ser\u2014Met\u2014Glu\u2014His\u2014Phe\u2014Arg\u2014Trp\u2014Gly\u2014<br data-start=\"134\" data-end=\"137\" \/>\u00a0 \u00a0 \u00a0 \u00a0Lys\u2014Pro\u2014Val\u2014Gly\u2014Lys\u2014Lys\u2014Arg\u2014Arg\u2014Pro \u2014Val\u2014<br data-start=\"177\" data-end=\"180\" \/>\u00a0 \u00a0 \u00a0 \u00a0Lys\u2014Val\u2014Tyr\u2014Pro\u2014OH<\/p>\n<p>C<sub>136<\/sub>H<sub>210<\/sub>N<sub>40<\/sub>O<sub>31<\/sub>S 2933 16960-16-0<\/p>\n<p><strong>Action and use<\/strong><\/p>\n<p>Corticotropic peptide.<\/p>\n<p><strong>Preparations<\/strong><\/p>\n<p>Tetracosactide Injection<\/p>\n<p>Tetracosactide Zinc Injection<\/p>\n<p>Ph Eur<\/p>\n<h2>DEFINITION<\/h2>\n<p>Synthetic human corticotropin-(1-24)-peptide. It increases the rate at which corticoid hormones are secreted by the adrenal glands. It is available as an acetate.<\/p>\n<p><strong>Content<\/strong><\/p>\n<p>90 per cent to 102 per cent (anhydrous and acetic acid-free substance). By convention, 1 \u03bcg of tetracosactide is equivalent to 1 IU of tetracosactide.<\/p>\n<h2>CHARACTERS<\/h2>\n<h3>Appearance<\/h3>\n<p>White or yellow, amorphous powder.<\/p>\n<h3>Solubility<\/h3>\n<p>Sparingly soluble in water.<\/p>\n<h2>IDENTIFICATION<\/h2>\n<p>A. Examine the chromatograms obtained in the assay.<\/p>\n<p>Results The principal peak in the chromatogram obtained with the test solution is similar in retention time and size to the principal peak in the chromatogram obtained with reference solution (b).<\/p>\n<p>B. Amino acid analysis (2.2.56). For hydrolysis use Method 1 and for analysis use Method 1 or Method 4.<\/p>\n<p>Express the content of each amino acid in moles. Calculate the relative proportions of the amino acids, taking that of valine to be equivalent to 3. The values fall within the following limits: lysine 3.5 to 4.7; histidine 0.9 to 1.1; arginine 2.7 to 3.3; serine 1.1 to 2.2; glutamic acid 0.9 to 1.1; proline 2.5 to 3.5; glycine 1.8 to 2.2; methionine 0.9 to 1.1; tyrosine 1.7 to 2.2; phenylalanine 0.9 to 1.1. Not more than traces of other amino acids are present.<\/p>\n<h2>TESTS<\/h2>\n<h3>Specific optical rotation (2.2.7)<\/h3>\n<p>-109 to -99 (anhydrous and acetic acid-free substance).<\/p>\n<p>Dissolve 10.0 mg in 1.0 mL of a mixture of 1 volume of glacial acetic acid R and 99 volumes of water R.<\/p>\n<h3>Absorbance (2.2.25)<\/h3>\n<p>0.51 to 0.61 (anhydrous and acetic acid-free substance), determined at the absorption maximum between 240 nm and 280 nm, at 276 nm. The ratio of the absorbance at the maximum at 276 nm to the absorbance at 248 nm is 2.4 to 2.9.<\/p>\n<p>Dissolve 1.0 mg in 0.1 M hydrochloric acid and dilute to 5.0 mL with the same acid.<\/p>\n<h3>Related peptides<\/h3>\n<p>Liquid chromatography (2.2.29): use the normalisation procedure.<\/p>\n<p>Test solution Dissolve an accurately weighed quantity of the substance to be examined in water R to obtain a concentration of 0.2 mg\/mL.<\/p>\n<p>Reference solution (a) Dissolve the contents of a vial of tetracosactide for peak identification CRS (containing impurities A, C, D, E, F, G, H, I and J) in water R to obtain a concentration of about 0.2 mg\/mL.<\/p>\n<p>Reference solution (b) Dissolve the contents of a vial of tetracosactide CRS in water R to obtain a concentration of about 0.2 mg\/mL.<\/p>\n<p>Reference solution (c) Dilute 1.0 mL of reference solution (b) to 100.0 mL with water R. Dilute 1.0 mL of this solution to 10.0 mL with water R.<\/p>\n<p>Column:<\/p>\n<p>&#8211; size: l = 0.15 m, \u00d8 = 4.6 mm;<\/p>\n<p>&#8211; stationary phase: end-capped ethylene-bridged phenylsilyl silica gel for chromatography (hybrid material) R (3.5 \u03bcm);<\/p>\n<p>&#8211; temperature: 60 \u00b0C.<\/p>\n<p>Mobile phase:<\/p>\n<p>&#8211; mobile phase A: a 0.1 per cent (V\/V) solution of methanesulfonic acid R in water for chromatography R;<\/p>\n<p>&#8211; mobile phase B: a 0.1 per cent (V\/V) solution of methanesulfonic acid R in a mixture of 50 volumes of water for chromatography R and 50 volumes of acetonitrile for chromatography R;<\/p>\n<table>\n<thead>\n<tr>\n<th><strong>Time (min)<\/strong><\/th>\n<th><strong>Mobile phase A (per cent V\/V)<\/strong><\/th>\n<th><strong>Mobile phase B (per cent V\/V)<\/strong><\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>0 \u2013 8<\/td>\n<td>80 \u2192 75<\/td>\n<td>20 \u2192 25<\/td>\n<\/tr>\n<tr>\n<td>8 \u2013 13<\/td>\n<td>75 \u2192 73<\/td>\n<td>25 \u2192 27<\/td>\n<\/tr>\n<tr>\n<td>13 \u2013 33<\/td>\n<td>73 \u2192 71<\/td>\n<td>27 \u2192 29<\/td>\n<\/tr>\n<tr>\n<td>33 \u2013 38<\/td>\n<td>71 \u2192 69<\/td>\n<td>29 \u2192 31<\/td>\n<\/tr>\n<tr>\n<td>38 \u2013 45<\/td>\n<td>69 \u2192 62<\/td>\n<td>31 \u2192 38<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>Flow rate 0.6 mL\/min.<\/p>\n<p>Detection Spectrophotometer at 220 nm.<\/p>\n<p>Autosampler Set at 5 \u00b0C.<\/p>\n<p>Injection 16 \u03bcL of the test solution and reference solutions (a) and (c).<\/p>\n<p>Identification of impurities Use the chromatogram supplied with tetracosactide for peak identification CRS and the chromatogram obtained with reference solution (a) to identify the peaks due to impurities A, C + D + E, F + G, H, and I + J.<\/p>\n<p>Relative retention With reference to tetracosactide (retention time = about 19 min): impurity A = about 0.67; impurities C, D and E = about 0.97; impurities F and G = about 1.07; impurity H = about 1.09; impurities J and I = about 1.15. Partial separation of the peaks due to impurities F and G as well as due to impurities J and I can be observed.<\/p>\n<p>System suitability Reference solution (a):<\/p>\n<p>&#8211; peak-to-valley ratio: minimum 3.0, where Hp = height above the baseline of the peak due to impurities C + D + E and Hv = height above the baseline of the lowest point of the curve separating this peak from the peak due to tetracosactide;<\/p>\n<p>&#8211; symmetry factor: maximum 2.5 for the peak due to tetracosactide.<\/p>\n<p>Limits:<\/p>\n<p>&#8211; impurity A: maximum 2.0 per cent;<\/p>\n<p>&#8211; sum of impurities C, D and E: maximum 1.0 per cent;<\/p>\n<p>&#8211; sum of impurities F and G: maximum 1.0 per cent;<\/p>\n<p>&#8211; impurity H: maximum 1.0 per cent;<\/p>\n<p>&#8211; sum of impurities I and J: maximum 1.0 per cent;<\/p>\n<p>&#8211; unspecified impurities: for each impurity, maximum 0.5 per cent;<\/p>\n<p>&#8211; total: maximum 5.0 per cent;<\/p>\n<p>&#8211; reporting threshold: 0.1 per cent (peak due to tetracosactide in the chromatogram obtained with reference solution (c)).<\/p>\n<h3>Acetic acid (2.5.34)<\/h3>\n<p>8.0 per cent to 13.0 per cent.<\/p>\n<p>Test solution Dissolve 10.0 mg of the substance to be examined in a mixture of 5 volumes of mobile phase B and 95 volumes of mobile phase A and dilute to 10.0 mL with the same mixture of mobile phases.<\/p>\n<h3>Water (2.5.32)<\/h3>\n<p>Maximum 14.0 per cent, determined on 20.0-50.0 mg.<\/p>\n<p>Bacterial endotoxins (2.6.14)<\/p>\n<p>Less than 10 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<h2>ASSAY<\/h2>\n<p>Liquid chromatography (2.2.29) as described in the test for related peptides with the following modifications.<\/p>\n<p>Injection Test solution and reference solution (b).<\/p>\n<p>Calculate the content of C136H210N40O31S using the chromatogram obtained with reference solution (b) and taking into account the assigned content of tetracosactide CRS.<\/p>\n<h2>STORAGE<\/h2>\n<p>Protected from light, at a temperature of 2 \u00b0C to 8 \u00b0C.<\/p>\n<h2>LABELLING<\/h2>\n<p>The label states:<\/p>\n<p>&#8211; the mass of peptide in the container;<\/p>\n<p>&#8211; where applicable, that the substance is suitable for use in the manufacture of parenteral preparations.<\/p>\n<h2>IMPURITIES<\/h2>\n<p>Specified impurities A, C, D, E, F, G, H, I, J.<\/p>\n<p>H\u2014Ser\u2014Tyr\u2014Ser\u2014MetO\u2014Glu\u2014His\u2014Phe\u2014Arg\u2014Trp\u2014Gly\u2014<br data-start=\"215\" data-end=\"218\" \/>\u00a0 \u00a0 \u00a0 \u00a0Lys\u2014Pro\u2014 Val\u2014Gly\u2014 Lys\u2014Lys \u2014Arg\u2014Arg\u2014 Pro\u2014Val\u2014<br data-start=\"258\" data-end=\"261\" \/>\u00a0 \u00a0 \u00a0 \u00a0Lys\u2014Val\u2014Tyr\u2014Pro\u2014OH<\/p>\n<p>A. [4-(L-methionine S-oxide)]tetracosactide,<\/p>\n<p>H\u2014 Tyr\u2014 Ser\u2014 Met \u2014Glu \u2014His\u2014 Phe\u2014Arg \u2014Trp\u2014Gly\u2014<br data-start=\"378\" data-end=\"381\" \/>\u00a0 \u00a0 \u00a0 Lys\u2014Pro\u2014Val\u2014Gly\u2014Lys\u2014Lys\u2014Arg\u2014Arg\u2014Pro\u2014Val\u2014<br data-start=\"421\" data-end=\"424\" \/>\u00a0 \u00a0 \u00a0 Lys\u2014Val\u2014Tyr\u2014Pro\u2014OH<\/p>\n<p>C. des-1-serine-tetracosactide,<\/p>\n<p>H\u2014Tyr\u2014 Met\u2014Glu\u2014 His\u2014 Phe\u2014 Arg\u2014 Trp \u2014 Gly\u2014Lys\u2014<br data-start=\"528\" data-end=\"531\" \/>\u00a0 \u00a0 \u00a0 Pro\u2014Val\u2014Gly\u2014Lys\u2014Lys\u2014Arg\u2014Arg\u2014Pro\u2014Val\u2014Lys\u2014<br data-start=\"571\" data-end=\"574\" \/>\u00a0 \u00a0 \u00a0 Val\u2014Tyr\u2014Pro\u2014OH<\/p>\n<p>D. des-3-serine-tetracosactide,<\/p>\n<p>H\u2014Ser\u2014Tyr\u2014Met\u2014Glu\u2014His\u2014Phe\u2014Arg\u2014Trp\u2014Gly\u2014Lys\u2014<br data-start=\"678\" data-end=\"681\" \/>\u00a0 \u00a0 \u00a0 Pro\u2014Val\u2014Gly\u2014Lys\u2014Lys\u2014Arg\u2014Arg\u2014 Pro\u2014Val\u2014 Lys\u2014<br data-start=\"721\" data-end=\"724\" \/>\u00a0 \u00a0 \u00a0 Val\u2014Tyr\u2014Pro\u2014OH<\/p>\n<p>E. [4-D-methionine]tetracosactide,<\/p>\n<p data-start=\"789\" data-end=\"899\">H\u2014Ser\u2014Tyr\u2014Ser\u2014D-Met\u2014Glu\u2014His\u2014Phe\u2014Arg\u2014Trp\u2014Gly\u2014<br data-start=\"833\" data-end=\"836\" \/>\u00a0 \u00a0 \u00a0 Lys \u2014Pro \u2014Val\u2014 Gly\u2014 Lys\u2014 Lys\u2014Arg\u2014Arg\u2014 Pro\u2014Val\u2014<br data-start=\"876\" data-end=\"879\" \/>\u00a0 \u00a0 \u00a0 Lys\u2014Val\u2014Tyr\u2014Pro\u2014OH<\/p>\n<p>F. endo-4a-(glutamic acid)-tetracosactide,<\/p>\n<p>H\u2014Ser\u2014Tyr\u2014 Ser\u2014 Met\u2014 Glu\u2014 His\u2014 Phe\u2014 Arg\u2014 Trp\u2014<br data-start=\"157\" data-end=\"160\" \/>\u00a0 \u00a0 \u00a0Gly\u2014Lys\u2014Pro\u2014Val\u2014Gly\u2014Lys\u2014Lys\u2014Arg\u2014Arg\u2014Pro\u2014<br data-start=\"200\" data-end=\"203\" \/>\u00a0 \u00a0 \u00a0Val\u2014Lys\u2014Val\u2014Tyr\u2014Pro\u2014OH<\/p>\n<p>G. unknown structure,<\/p>\n<p>H\u2014Ser\u2014Tyr\u2014Ser\u2014Met\u2014Glu\u2014His\u2014Phe\u2014Arg\u2014Trp\u2014Gly\u2014<br data-start=\"360\" data-end=\"363\" \/>\u00a0 \u00a0 \u00a0 Lys\u2014 Pro \u2014Val \u2014 Gly \u2014 Lys\u2014 Lys\u2014 Arg\u2014Arg \u2014 Pro \u2014<br data-start=\"399\" data-end=\"402\" \/>\u00a0 \u00a0 \u00a0 Val\u2014Lys\u2014Val\u2014Tyr\u2014Pro\u2014OH<\/p>\n<p>H. endo-13a-glycine-tetracosactide,<\/p>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"alignnone wp-image-29477\" style=\"color: #555555;\" src=\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/Tetracosactide-2-1024x256.jpg\" alt=\"Tetracosactide\" width=\"600\" height=\"150\" srcset=\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/Tetracosactide-2-1024x256.jpg 1024w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/Tetracosactide-2-300x75.jpg 300w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/Tetracosactide-2-768x192.jpg 768w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/Tetracosactide-2.jpg 1200w\" sizes=\"auto, (max-width: 600px) 100vw, 600px\" \/><\/p>\n<p>I. acetyltetracosactide-(3-24)-peptide,<\/p>\n<p>H\u2014Ser\u2014Tyr\u2014Ser\u2014Met\u2014His\u2014Phe\u2014 Arg\u2014 Trp\u2014Gly\u2014 Lys\u2014<br data-start=\"684\" data-end=\"687\" \/>\u00a0 \u00a0 \u00a0 Pro\u2014Val\u2014Gly\u2014Lys\u2014Lys\u2014Arg\u2014Arg\u2014Pro\u2014Val\u2014Lys\u2014Val\u2014<br data-start=\"731\" data-end=\"734\" \/>\u00a0 \u00a0 \u00a0 Tyr\u2014Pro\u2014OH<\/p>\n<p>J. des-5-(glutamic acid)-tetracosactide.<\/p>\n<p>Ph Eur<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Edition: BP 2025 (Ph. Eur. 11.6 update) (Ph. Eur. monograph 0644) H\u2014Ser\u2014Tyr\u2014Ser\u2014Met\u2014Glu\u2014His\u2014Phe\u2014Arg\u2014Trp\u2014Gly\u2014\u00a0 \u00a0 \u00a0 \u00a0Lys\u2014Pro\u2014Val\u2014Gly\u2014Lys\u2014Lys\u2014Arg\u2014Arg\u2014Pro \u2014Val\u2014\u00a0 \u00a0 \u00a0 \u00a0Lys\u2014Val\u2014Tyr\u2014Pro\u2014OH C136H210N40O31S 2933 16960-16-0 Action and use Corticotropic peptide. Preparations Tetracosactide Injection Tetracosactide Zinc Injection Ph Eur DEFINITION Synthetic human corticotropin-(1-24)-peptide. It increases the rate at which corticoid hormones are secreted by the adrenal glands. It is&#8230;<\/p>\n","protected":false},"author":5,"featured_media":29480,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[174],"tags":[],"class_list":["post-29428","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\/29428","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=29428"}],"version-history":[{"count":2,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/29428\/revisions"}],"predecessor-version":[{"id":29483,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/29428\/revisions\/29483"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/29480"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=29428"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=29428"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=29428"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}