Androgen.<\/p>\n
Ph Eur<\/p>\n
DEFINITION<\/h2>\n
3-Oxoandrost-4-en-17\u03b2-yl 4-methylpentanoate.<\/p>\n
Content<\/strong><\/p>\n 97.0 per cent to 102.0 per cent (dried substance).<\/p>\n Appearance: Solubility: A.\u2003Infrared absorption spectrophotometry (2.2.24). B.\u2003Examine the chromatograms obtained in the assay. Appearance of solution<\/p>\n The solution is clear (2.2.1) and not more intensely coloured than reference solution BY6 (2.2.2, Method II). Specific optical rotation (2.2.7)<\/p>\n +82.0 to +88.0 (dried substance). Related substances<\/p>\n Liquid chromatography (2.2.29).<\/p>\n Test solution: Reference solution (a): Reference solution (b): Reference solution (c): Column: Mobile phase: Flow rate: Detection: Injection: Run time: Identification of impurities: Relative retention: System suitability: Limits: Free acid<\/p>\n Dissolve 0.44 g in 10 mL of ethanol (96 per cent) R, previously neutralised to bromothymol blue solution R3, and titrate immediately with 0.01 M sodium hydroxide, using 0.1 mL of bromothymol blue solution R3 as indicator. Loss on drying (2.2.32)<\/p>\n Maximum 0.5 per cent, determined on 1.000 g by drying in vacuo at a pressure not exceeding 0.7 kPa.<\/p>\n Liquid chromatography (2.2.29) as described in the test for related substances with the following modification.<\/p>\n Injection: Calculate the percentage content of C\u2082\u2085H\u2083\u2088O\u2083 from the declared content of testosterone isocaproate CRS.<\/p>\n Specified impurities: <\/p>\n <\/p>\n <\/p>\n <\/p>\n <\/p>\n <\/p>\n <\/p>\n Edition: BP 2025 (Ph. Eur. 11.6 update) (Ph. Eur. monograph 1737) C\u2082\u2085H\u2083\u2088O\u2083\u2003386.6 Action and use Androgen. Ph Eur DEFINITION 3-Oxoandrost-4-en-17\u03b2-yl 4-methylpentanoate. Content 97.0 per cent to 102.0 per cent (dried substance). CHARACTERS Appearance: White or almost white powder. Solubility: Practically insoluble in water, very soluble in acetone and in methylene chloride, freely soluble in fatty…<\/p>\n","protected":false},"author":5,"featured_media":29216,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[174],"tags":[],"class_list":["post-29215","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\/29215","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=29215"}],"version-history":[{"count":2,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/29215\/revisions"}],"predecessor-version":[{"id":29272,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/29215\/revisions\/29272"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/29216"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=29215"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=29215"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=29215"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}CHARACTERS<\/h2>\n
\nWhite or almost white powder.<\/p>\n
\nPractically insoluble in water, very soluble in acetone and in methylene chloride, freely soluble in fatty oils.<\/p>\nIDENTIFICATION<\/h2>\n
\nComparison\u2003testosterone isocaproate CRS.<\/p>\n
\nResults\u2003The 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 (c).<\/p>\nTESTS<\/h2>\n
\nDissolve 0.20 g in 20 mL of methanol R.<\/p>\n
\nDissolve 0.200 g in anhydrous ethanol R and dilute to 20.0 mL with the same solvent.<\/p>\n
\nDissolve 20.0 mg of the substance to be examined in the mobile phase and dilute to 100.0 mL with the mobile phase.<\/p>\n
\nDissolve 2 mg of testosterone isocaproate for system suitability CRS (containing impurities A, B, C, D, E, F and G) in 10 mL of the mobile phase.<\/p>\n
\nDilute 10.0 mL of the test solution to 100.0 mL with the mobile phase. Dilute 1.0 mL of this solution to 20.0 mL with the mobile phase.<\/p>\n
\nDissolve 20.0 mg of testosterone isocaproate CRS in the mobile phase and dilute to 100.0 mL with the mobile phase.<\/p>\n
\n\u2014 size: l = 0.25 m, \u00d8 = 4.6 mm;
\n\u2014 stationary phase: end-capped octadecylsilyl silica gel for chromatography R (5 \u00b5m);
\n\u2014 temperature: 40\u202f\u00b0C.<\/p>\n
\nwater R, acetonitrile R (15:85 V\/V).<\/p>\n
\n1.0 mL\/min.<\/p>\n
\nSpectrophotometer at 240 nm.<\/p>\n
\n20 \u00b5L of the test solution and reference solutions (a) and (b).<\/p>\n
\nTwice the retention time of testosterone isocaproate.<\/p>\n
\nUse the chromatogram supplied with testosterone isocaproate for system suitability CRS and the chromatogram obtained with reference solution (a) to identify the peaks due to impurities A, B, C, D, E, F and G.<\/p>\n
\nWith reference to testosterone isocaproate (retention time = about 14 min):
\nimpurity A = about 0.2;
\nimpurity B = about 0.4;
\nimpurity C = about 0.5;
\nimpurity D = about 0.7;
\nimpurity G = about 0.8;
\nimpurity E = about 1.1;
\nimpurity F = about 1.4.<\/p>\n
\nReference solution (a):
\n\u2014 peak-to-valley ratio: minimum 2.5, where Hp = height above the baseline of the peak due to impurity E and Hv = height above the baseline of the lowest point of the curve separating this peak from the peak due to testosterone isocaproate.<\/p>\n
\n\u2014 impurities A, B, C, D, E, F, G: for each impurity, not more than the area of the principal peak in the chromatogram obtained with reference solution (b) (0.5 per cent);
\n\u2014 unspecified impurities: for each impurity, not more than 0.2 times the area of the principal peak in the chromatogram obtained with reference solution (b) (0.10 per cent);
\n\u2014 total: not more than twice the area of the principal peak in the chromatogram obtained with reference solution (b) (1.0 per cent);
\n\u2014 disregard limit: 0.1 times the area of the principal peak in the chromatogram obtained with reference solution (b) (0.05 per cent).<\/p>\n
\nNot more than 0.6 mL of 0.01 M sodium hydroxide is required to change the colour of the indicator to blue.<\/p>\nASSAY<\/h2>\n
\n20 \u00b5L of the test solution and reference solution (c).<\/p>\nIMPURITIES<\/h2>\n
\nA, B, C, D, E, F, G.<\/p>\n![\"\"](\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/Testosterone-Isocaproate-1.jpg\")
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