{"id":29188,"date":"2025-11-10T15:12:23","date_gmt":"2025-11-10T08:12:23","guid":{"rendered":"https:\/\/nhathuocngocanh.com\/bp\/?p=29188"},"modified":"2025-11-10T15:12:23","modified_gmt":"2025-11-10T08:12:23","slug":"testosterone-propionate","status":"publish","type":"post","link":"https:\/\/nhathuocngocanh.com\/bp\/testosterone-propionate\/","title":{"rendered":"Testosterone Propionate"},"content":{"rendered":"

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

(Ph. Eur. monograph 0297)<\/p>\n

C\u2082\u2082H\u2083\u2082O\u2083\u2003344.5\u200357-85-2<\/p>\n

Androgen.<\/p>\n

Preparation<\/p>\n

Testosterone Propionate Injection<\/p>\n

Ph Eur<\/p>\n

DEFINITION<\/h2>\n

3-Oxoandrost-4-en-17\u03b2-yl propanoate.<\/p>\n

Content<\/p>\n

97.5 per cent to 102.0 per cent (dried substance).<\/p>\n

CHARACTERS<\/h2>\n

Appearance:
\nWhite or almost white powder or colourless crystals.<\/p>\n

Solubility:
\nPractically insoluble in water, freely soluble in acetone and in ethanol (96 per cent), soluble in fatty oils.<\/p>\n

IDENTIFICATION<\/h2>\n

Testosterone Propionate
\nInfrared absorption spectrophotometry (2.2.24).
\nComparison testosterone propionate CRS.<\/p>\n

TESTS<\/h2>\n

Specific optical rotation (2.2.7)<\/p>\n

+84 to +90 (dried substance).
\nDissolve 0.250 g in ethanol R and dilute to 25.0 mL with the same solvent.<\/p>\n

Related substances<\/p>\n

Liquid chromatography (2.2.29).<\/p>\n

Test solution:
\nDissolve 20.0 mg of the substance to be examined in methanol R and dilute to 50.0 mL with the same solvent.<\/p>\n

Reference solution (a):
\nDissolve 2 mg of testosterone propionate for system suitability CRS (containing impurities A, B and C) in 5.0 mL of methanol R.<\/p>\n

Reference solution (b):
\nDilute 1.0 mL of the test solution to 100.0 mL with methanol R. Dilute 1.0 mL of this solution to 10.0 mL with methanol R.<\/p>\n

Reference solution (c):
\nDissolve 20.0 mg of testosterone propionate CRS in 50.0 mL of methanol R.<\/p>\n

Column:
\n\u2014 size: l = 0.25 m, \u00d8 = 4.6 mm;
\n\u2014 stationary phase: octadecylsilyl silica gel for chromatography R (5 \u00b5m).<\/p>\n

Mobile phase:
\nwater R, methanol R (20:80 V\/V).<\/p>\n

Flow rate:
\n1.5 mL\/min.<\/p>\n

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

Injection:
\n20 \u00b5L of the test solution and reference solutions (a) and (b).<\/p>\n

Run time:
\nTwice the retention time of testosterone propionate.<\/p>\n

Identification of impurities:
\nUse the chromatogram supplied with testosterone propionate for system suitability CRS and the chromatogram obtained with reference solution (a) to identify the peaks due to impurities A, B and C.<\/p>\n

Relative retention:
\nWith reference to testosterone propionate (retention time = about 8 min):
\nimpurity C = about 0.4;
\nimpurity A = about 0.7;
\nimpurity B = about 1.4.<\/p>\n

System suitability:
\nReference solution (a):
\n\u2014 peak-to-valley ratio: minimum 3.0, where Hp = height above the baseline of the peak due to impurity B and Hv = height above the baseline of the lowest point of the curve separating this peak from the peak due to testosterone propionate.<\/p>\n

Limits:
\n\u2014 impurity A: not more than 5 times the area of the principal peak in the chromatogram obtained with reference solution (b) (0.5 per cent);
\n\u2014 impurity C: not more than twice the area of the principal peak in the chromatogram obtained with reference solution (b) (0.2 per cent);
\n\u2014 unspecified impurities: for each impurity, not more than the area of the principal peak in the chromatogram obtained with reference solution (b) (0.10 per cent);
\n\u2014 total: not more than 7 times the area of the principal peak in the chromatogram obtained with reference solution (b) (0.7 per cent);
\n\u2014 disregard limit: 0.5 times the area of the principal peak in the chromatogram obtained with reference solution (b) (0.05 per cent).<\/p>\n

Loss on drying (2.2.32)<\/p>\n

Maximum 0.5 per cent, determined on 1.000 g by drying in an oven at 105\u202f\u00b0C for 2 h.<\/p>\n

ASSAY<\/h2>\n

Liquid chromatography (2.2.29) as described in the test for related substances with the following modification.<\/p>\n

Injection:
\nTest solution and reference solution (c).<\/p>\n

Calculate the percentage content of C\u2082\u2082H\u2083\u2082O\u2083 taking into account the assigned content of testosterone propionate CRS.<\/p>\n

IMPURITIES<\/h2>\n

Specified impurities:
\nA, C.<\/p>\n

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):
\nB, D, E.<\/p>\n

 <\/p>\n

\"\"
A.\u20033-oxoandrost-4-en-17\u03b2-yl acetate (testosterone acetate),<\/figcaption><\/figure>\n

 <\/p>\n

\"\"
B.\u20033-oxoandrost-4-en-17\u03b2-yl 2-methylpropanoate (testosterone isobutyrate),<\/figcaption><\/figure>\n

 <\/p>\n

\"\"
C.\u200317\u03b2-hydroxyandrost-4-en-3-one (testosterone),<\/figcaption><\/figure>\n

 <\/p>\n

\"\"
D.\u20033-oxoandrosta-1,4-dien-17\u03b2-yl propanoate,<\/figcaption><\/figure>\n

 <\/p>\n

\"\"
E.\u20033-oxoandrosta-4,6-dien-17\u03b2-yl propanoate.<\/figcaption><\/figure>\n","protected":false},"excerpt":{"rendered":"

Edition: BP 2025 (Ph. Eur. 11.6 update) (Ph. Eur. monograph 0297) C\u2082\u2082H\u2083\u2082O\u2083\u2003344.5\u200357-85-2 Androgen. Preparation Testosterone Propionate Injection Ph Eur DEFINITION 3-Oxoandrost-4-en-17\u03b2-yl propanoate. Content 97.5 per cent to 102.0 per cent (dried substance). CHARACTERS Appearance: White or almost white powder or colourless crystals. Solubility: Practically insoluble in water, freely soluble in acetone and in ethanol (96…<\/p>\n","protected":false},"author":5,"featured_media":29189,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[174],"tags":[],"class_list":["post-29188","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\/29188","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=29188"}],"version-history":[{"count":2,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/29188\/revisions"}],"predecessor-version":[{"id":29214,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/29188\/revisions\/29214"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/29189"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=29188"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=29188"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=29188"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}