{"id":15666,"date":"2025-10-18T10:47:59","date_gmt":"2025-10-18T03:47:59","guid":{"rendered":"https:\/\/nhathuocngocanh.com\/bp\/?p=15666"},"modified":"2025-10-18T10:47:59","modified_gmt":"2025-10-18T03:47:59","slug":"gonadorelin-acetate","status":"publish","type":"post","link":"https:\/\/nhathuocngocanh.com\/bp\/gonadorelin-acetate\/","title":{"rendered":"Gonadorelin Acetate"},"content":{"rendered":"<p><em>(Ph. Eur. monograph 0827)<\/em><\/p>\n<p>C<sub>57<\/sub>H<sub>79<\/sub>N<sub>17<\/sub>O<sub>15<\/sub> 1242 499785-55-6<\/p>\n<p><strong>Action and use<\/strong><\/p>\n<p>Gonadotropin-releasing hormone; treatment of prostate cancer.<\/p>\n<h2>DEFINITION<\/h2>\n<p>5-Oxo-L-prolyl-L-histidyl-L-tryptophyl-L-seryl-L-tyrosylglycyl-L-leucyl-L-arginyl-L-prolylglycinamide acetate.<\/p>\n<p>Acetate form of a synthetic hypothalamic peptide that stimulates the release of follicle-stimulating hormone and luteinising hormone from the pituitary gland.<\/p>\n<h3>Content<\/h3>\n<p>95.0 per cent to 102.0 per cent of the peptide C55H75N17O13 (anhydrous and acetic acid-free substance).<\/p>\n<h2>CHARACTERS<\/h2>\n<h3>Appearance<\/h3>\n<p>White or slightly yellowish powder, hygroscopic.<\/p>\n<h3>Solubility<\/h3>\n<p>Soluble in water, sparingly soluble in methanol. It dissolves in a 1 per cent V\/V solution of glacial acetic acid.<\/p>\n<h2>IDENTIFICATION<\/h2>\n<p>Carry out either tests A, B or tests A, C.<\/p>\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 (a).<\/p>\n<p>B. Nuclear magnetic resonance spectrometry (2.2.64).<\/p>\n<p>Preparation 4 mg\/mL solution in a mixture of 20 volumes of deuterated acetic acid R and 80 volumes of deuterium oxide R.<\/p>\n<p>Comparison: Dissolve the contents of a vial of gonadorelin for NMR identification CRS in a mixture of 20 volumes of deuterated acetic acid R and 80 volumes of deuterium oxide R to obtain a concentration of 4 mg\/mL.<\/p>\n<p>Operating conditions:<\/p>\n<p>\u2014 field strength: minimum 300 MHz;<\/p>\n<p>\u2014 temperature: 27 \u00b0C.<\/p>\n<p>Results: Examine the H NMR spectrum from 0 ppm to 9 ppm. The H NMR spectrum obtained is qualitatively similar to the H NMR spectrum obtained with gonadorelin for NMR identification CRS.<\/p>\n<p>C. Amino acid analysis (2.2.56). Method 1 for hydrolysis and method 1 for analysis are suitable.<\/p>\n<p>Express the content of each amino acid in moles. Calculate the relative proportions of the amino acids, taking 1\/8 of the sum of the number of moles of histidine, glutamic acid, leucine, proline, glycine, tyrosine and arginine as equal to 1. The values fall within the following limits: serine and tyrosine 0.7 to 1.05; glutamic acid, proline, leucine, histidine and arginine 0.9 to 1.1; glycine 1.8 to 2.2. Lysine and isoleucine are absent, and 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>-65 to -58 (anhydrous and acetic acid-free substance).<\/p>\n<p>Dissolve 10.0 mg in 1.0 mL of a 1 per cent V\/V solution of glacial acetic acid R.<\/p>\n<h3>Related substances<\/h3>\n<p>Liquid chromatography (2.2.29).<\/p>\n<p>Test solution: Dissolve the substance to be examined in water R to obtain a concentration of 1.0 mg\/mL.<\/p>\n<p>Reference solution (a): Dissolve the contents of a vial of gonadorelin CRS in water R to obtain a concentration of 1.0 mg\/mL.<\/p>\n<p>Reference solution (b): Dilute 1.0 mL of the test solution to 100.0 mL with water R.<\/p>\n<p>Reference solution (c): Dissolve the contents of a vial of gonadorelin for system suitability A CRS (containing impurities C, E, F and G) in 1.0 mL of water R.<\/p>\n<p>Column:<\/p>\n<p>\u2014 size: l = 0.125 m, \u00d8 = 4.0 mm;<\/p>\n<p>\u2014 stationary phase: end-capped octadecylsilyl silica gel for chromatography R (5 \u03bcm).<\/p>\n<p>Mobile phase: Mix 13 volumes of acetonitrile R1 and 87 volumes of a 1.18 per cent V\/V solution of phosphoric acid R previously adjusted to pH 2.3 with triethylamine R.<\/p>\n<p>Flow rate: 1.5 mL\/min.<\/p>\n<p>Detection: Spectrophotometer at 215 nm.<\/p>\n<p>Injection: 10 \u03bcL of the test solution and reference solutions (b) and (c).<\/p>\n<p>Run time: Twice the retention time of gonadorelin.<\/p>\n<p>Relative retention: With reference to gonadorelin (retention time = about 12-16 min): impurity C = about 0.7; impurity E = about 0.8; impurities F and G = about 1.2.<\/p>\n<p>System suitability: Reference solution (c):<\/p>\n<p>\u2014 resolution: minimum 1.5 between the peaks due to impurities C and E.<\/p>\n<p>Limits:<\/p>\n<p>\u2014 impurity E: maximum 2.0 per cent;<\/p>\n<p>\u2014 sum of impurities F and G: maximum 1.5 per cent;<\/p>\n<p>\u2014 impurity C: maximum 1.0 per cent;<\/p>\n<p>\u2014 unspecified impurities: for each impurity, maximum 0.5 per cent;<\/p>\n<p>\u2014 total: maximum 5.0 per cent;<\/p>\n<p>\u2014 reporting threshold: 0.1 per cent.<\/p>\n<h3>Acetic acid (2.5.34)<\/h3>\n<p>4.0 per cent to 7.5 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 solvents.<\/p>\n<h3>Water (2.5.32)<\/h3>\n<p>Maximum 7.0 per cent, determined on 20.0 mg.<\/p>\n<h2>ASSAY<\/h2>\n<p>Liquid chromatography (2.2.29) as described in the test for related substances with the following modification.<\/p>\n<p>Injection: Test solution and reference solution (a).<\/p>\n<p>Calculate the percentage content of gonadorelin (C<sub>55<\/sub>H<sub>75<\/sub>N<sub>17<\/sub>O<sub>13<\/sub>) taking into account the assigned content of C<sub>55<\/sub>H<sub>75<\/sub>N<sub>17<\/sub>O<sub>13<\/sub> in gonadorelin CRS.<\/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:<\/p>\n<p>\u2014 the gonadorelin peptide content;<\/p>\n<p>\u2014 where applicable, that the substance is suitable for use in the manufacture of parenteral preparations.<\/p>\n<h2>IMPURITIES<\/h2>\n<p>Specified impurities C, E, F, G.<\/p>\n<p>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 and\/or by the general monograph Substances for pharmaceutical use (2034). 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) D.<\/p>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"alignnone size-medium wp-image-15874\" src=\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/2-231-300x163.jpg\" alt=\"Gonadorelin Acetate \" width=\"300\" height=\"163\" srcset=\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/2-231-300x163.jpg 300w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/2-231-1024x555.jpg 1024w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/2-231-768x416.jpg 768w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/2-231.jpg 1200w\" sizes=\"auto, (max-width: 300px) 100vw, 300px\" \/><\/p>\n<p>C. des-9-L-proline,10-L-glycine-gonadorelin,<\/p>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"alignnone size-medium wp-image-15876\" src=\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/4-197-300x163.jpg\" alt=\"Gonadorelin Acetate\" width=\"300\" height=\"163\" srcset=\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/4-197-300x163.jpg 300w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/4-197-1024x555.jpg 1024w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/4-197-768x416.jpg 768w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/4-197.jpg 1200w\" sizes=\"auto, (max-width: 300px) 100vw, 300px\" \/><\/p>\n<p>D. [3-D-tryptophan]gonadorelin,<\/p>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"alignnone size-medium wp-image-15875\" src=\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/3-216-300x163.jpg\" alt=\"Gonadorelin Acetate\" width=\"300\" height=\"163\" srcset=\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/3-216-300x163.jpg 300w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/3-216-1024x555.jpg 1024w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/3-216-768x416.jpg 768w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/3-216.jpg 1200w\" sizes=\"auto, (max-width: 300px) 100vw, 300px\" \/><\/p>\n<p>E. [2-D-histidine]gonadorelin,<\/p>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"alignnone size-medium wp-image-15877\" src=\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/5-158-300x163.jpg\" alt=\"Gonadorelin Acetate \" width=\"300\" height=\"163\" srcset=\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/5-158-300x163.jpg 300w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/5-158-1024x555.jpg 1024w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/5-158-768x416.jpg 768w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/5-158.jpg 1200w\" sizes=\"auto, (max-width: 300px) 100vw, 300px\" \/><\/p>\n<p>F. [10-glycine]gonadorelin,<\/p>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"alignnone size-medium wp-image-15878\" src=\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/6-124-300x163.jpg\" alt=\"Gonadorelin Acetate \" width=\"300\" height=\"163\" srcset=\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/6-124-300x163.jpg 300w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/6-124-1024x555.jpg 1024w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/6-124-768x416.jpg 768w, https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/10\/6-124.jpg 1200w\" sizes=\"auto, (max-width: 300px) 100vw, 300px\" \/><\/p>\n<p>G. endo-5a-glycine-gonadorelin.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>(Ph. Eur. monograph 0827) C57H79N17O15 1242 499785-55-6 Action and use Gonadotropin-releasing hormone; treatment of prostate cancer. DEFINITION 5-Oxo-L-prolyl-L-histidyl-L-tryptophyl-L-seryl-L-tyrosylglycyl-L-leucyl-L-arginyl-L-prolylglycinamide acetate. Acetate form of a synthetic hypothalamic peptide that stimulates the release of follicle-stimulating hormone and luteinising hormone from the pituitary gland. Content 95.0 per cent to 102.0 per cent of the peptide C55H75N17O13 (anhydrous and acetic&#8230;<\/p>\n","protected":false},"author":4,"featured_media":15873,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[174],"tags":[],"class_list":["post-15666","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\/15666","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\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/comments?post=15666"}],"version-history":[{"count":3,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/15666\/revisions"}],"predecessor-version":[{"id":15879,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/15666\/revisions\/15879"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/15873"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=15666"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=15666"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=15666"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}