{"id":28941,"date":"2025-11-10T09:39:57","date_gmt":"2025-11-10T02:39:57","guid":{"rendered":"https:\/\/nhathuocngocanh.com\/bp\/?p=28941"},"modified":"2025-11-10T22:42:06","modified_gmt":"2025-11-10T15:42:06","slug":"testosterone","status":"publish","type":"post","link":"https:\/\/nhathuocngocanh.com\/bp\/testosterone\/","title":{"rendered":"Testosterone"},"content":{"rendered":"

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

(Ph. Eur. monograph 1373)<\/p>\n

$\"Testosterone\"$ <\/p>\n

C_{19<\/sub>H_{28<\/sub>O_{2<\/sub>\u00a0 \u00a0 \u00a0 \u00a0288.4\u00a0 \u00a0 \u00a0 \u00a058-22-0<\/p>\n}}}

Action and use<\/strong><\/p>\n

Androgen.<\/p>\n

Preparation<\/strong><\/p>\n

Testosterone Implants<\/p>\n

Ph Eur<\/p>\n

DEFINITION<\/h2>\n
17\u03b2-Hydroxyandrost-4-en-3-one.<\/p>\n
Content<\/strong><\/p>\n
98.0 per cent to 102.0 per cent (dried substance).<\/p>\n
CHARACTERS<\/h2>\n
Appearance<\/h3>\n
White or almost white crystalline powder, or colourless or yellowish-white crystals.<\/p>\n
Solubility<\/h3>\n
Practically insoluble in water, freely soluble in ethanol (96 per cent) and in methylene chloride, practically insoluble in fatty oils.<\/p>\n
mp<\/h3>\n
About 155 \u00b0C.<\/p>\n
IDENTIFICATION<\/h2>\n
Infrared absorption spectrophotometry (2.2.24).<\/p>\n
Comparison testosterone for ID and assay CRS.<\/p>\n
TESTS<\/h2>\n
Specific optical rotation (2.2.7)<\/h3>\n
+ 106 to + 114 (dried substance).<\/p>\n
Dissolve 0.250 g in anhydrous ethanol R and dilute to 25.0 mL with the same solvent.<\/p>\n
Related substances<\/h3>\n
Liquid chromatography (2.2.29).<\/p>\n
Solvent mixture\u00a0 \u00a0acetonitrile R, water R (30:70 V\/V).<\/p>\n
Test solution\u00a0 \u00a0Dissolve 35.0 mg of the substance to be examined in 30 mL of acetonitrile R and dilute to 100.0 mL with water R.<\/p>\n
Reference solution (a)\u00a0 \u00a0Dissolve 9 mg of testosterone for system suitability A CRS (containing impurities C, G and K) in 8 mL of acetonitrile R and dilute to 25 mL with water R.<\/p>\n
Reference solution (b)\u00a0 \u00a0Dissolve 7.0 mg of testosterone impurity I CRS in 30 mL of acetonitrile R and dilute to 100.0 mL with water R. Dilute 1.0 mL of the solution to 100.0 mL with the solvent mixture.<\/p>\n
Reference solution (c)\u00a0 \u00a0Dilute 1.0 mL of the test solution to 100.0 mL with the solvent mixture. Dilute 1.0 mL of this solution to 10.0 mL with the solvent mixture.<\/p>\n
Reference solution (d)\u00a0 \u00a0Dissolve 35.0 mg of testosterone for ID and assay CRS in 30 mL of acetonitrile R and dilute to 100.0 mL with water R.<\/p>\n
Column:<\/p>\n
\u2014 size: l = 0.10 m, \u00d8 = 4.6 mm;<\/p>\n
\u2014 stationary phase: end-capped solid core phenylhexylsilyl silica gel for chromatography R (2.7 \u03bcm);<\/p>\n
\u2014 temperature: 30 \u00b0C.<\/p>\n
Mobile phase:<\/p>\n
\u2014 mobile phase A: water for chromatography R;<\/p>\n
\u2014 mobile phase B: acetonitrile for chromatography R;<\/p>\n\n\n\n\n\n\n\n
Time (min)<\/td>\n Mobile phase A (per cent V\/V)<\/td>\n Mobile phase B (per cent V\/V)<\/td>\n<\/tr>\n
0 – 2.7<\/td>\n 65<\/td>\n 35<\/td>\n<\/tr>\n
2.7 – 7<\/td>\n 65 \u2192 63<\/td>\n 35 \u2192 37<\/td>\n<\/tr>\n
7 – 10<\/td>\n 63 \u2192 10<\/td>\n 37 \u2192 90<\/td>\n<\/tr>\n
10 – 12<\/td>\n 10<\/td>\n 90<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n
Flow rate\u00a0 \u00a01.5 mL\/min.<\/p>\n
Detection Spectrophotometer at 242 nm, and for impurity I, at 290 nm.<\/p>\n
Injection 20 \u03bcL of the test solution and reference solutions (a), (b) and (c).<\/p>\n
Identification of impurities\u00a0 \u00a0Use the chromatogram supplied with testosterone for system suitability A CRS and the chromatogram obtained with reference solution (a) to identify the peaks due to impurities C, G and K; use the chromatogram obtained with reference solution (b) to identify the peak due to impurity I.<\/p>\n
Relative retention\u00a0 \u00a0With reference to testosterone (retention time = about 4 min): impurity I = about 0.84; impurity K = about 0.86; impurity G = about 1.1; impurity C = about 1.3.<\/p>\n
System suitability\u00a0 \u00a0Reference solution (a):<\/p>\n
\u2014 peak-to-valley ratio: minimum 2.0, where H_{p<\/sub> = height above the baseline of the peak due to impurity G and<\/p>\n}
H_{v<\/sub> = height above the baseline of the lowest point of the curve separating this peak from the peak due to testosterone.<\/p>\n}
Calculation of percentage contents:<\/p>\n
\u2014 for impurity I, use the concentration of impurity I in reference solution (b);<\/p>\n
\u2014 for impurities other than I, use the concentration of testosterone in reference solution (c).<\/p>\n
Limits:<\/p>\n
\u2014 impurity C: maximum 0.3 per cent;<\/p>\n
\u2014 impurity I at 290 nm: maximum 0.2 per cent;<\/p>\n
\u2014 impurity K: maximum 0.15 per cent;<\/p>\n
\u2014 unspecified impurities: for each impurity, maximum 0.10 per cent;<\/p>\n
\u2014 total: maximum 0.6 per cent;<\/p>\n
\u2014 reporting threshold: 0.05 per cent.<\/p>\n
Loss on drying (2.2.32)<\/h3>\n
Maximum 1.0 per cent, determined on 0.500 g by drying in an oven at 105 \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 5 \u03bcL of the test solution and reference solution (d).<\/p>\n
Calculate the percentage content of C_{19<\/sub>H_{28<\/sub>O_{2<\/sub> taking into account the assigned content of testosterone for ID and assay CRS.<\/p>\n}}}
STORAGE<\/h2>\n
Protected from light.<\/p>\n
IMPURITIES<\/h2>\n
Specified impurities C, I, K.<\/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) A, B, E, G, H, J, L, M.<\/p>\n
$\"Testosterone\"$ <\/p>\n
A. androst-4-ene-3,17-dione (androstenedione),<\/p>\n
$\"Testosterone\"$ <\/p>\n
B. 3-ethoxyandrosta-3,5-dien-17-one (androstenedione ethylenolether),<\/p>\n
$\"Testosterone\"$ <\/p>\n
C. 17\u03b1-hydroxyandrost-4-en-3-one (17-epi-testosterone),<\/p>\n
$\"Testosterone\"$ <\/p>\n
E. 3-oxoandrost-4-en-17\u03b2-yl acetate (testosterone acetate),<\/p>\n
$\"Testosterone\"$ <\/p>\n
G. androsta-1,4-diene-3,17-dione (androstadienedione),<\/p>\n
$\"Testosterone\"$ <\/p>\n
H. 17\u03b2-hydroxyandrosta-1,4-dien-3-one (boldenone),<\/p>\n
$\"Testosterone\"$ <\/p>\n
I. 17\u03b2-hydroxyandrosta-4,6-dien-3-one (\u03946-testosterone),<\/p>\n
$\"Testosterone\"$ <\/p>\n
J. 3-methoxyandrosta-3,5-dien-17-one (androstenedione methylenolether),<\/p>\n
$\"Testosterone\"$ <\/p>\n
K. 17\u03b2-hydroxyandrosta-4,8-dien-3-one,<\/p>\n
$\"Testosterone\"$ <\/p>\n
L. 17\u03b2-hydroxyandrosta-4,9(11)-dien-3-one,<\/p>\n
$\"Testosterone\"$ <\/p>\n
M. 17\u03b2-hydroxyandrosta-4,8(14)-dien-3-one.<\/p>\n
Ph Eur<\/p>\n","protected":false},"excerpt":{"rendered":"
Edition: BP 2025 (Ph. Eur. 11.6 update) (Ph. Eur. monograph 1373) C19H28O2\u00a0 \u00a0 \u00a0 \u00a0288.4\u00a0 \u00a0 \u00a0 \u00a058-22-0 Action and use Androgen. Preparation Testosterone Implants Ph Eur DEFINITION 17\u03b2-Hydroxyandrost-4-en-3-one. Content 98.0 per cent to 102.0 per cent (dried substance). CHARACTERS Appearance White or almost white crystalline powder, or colourless or yellowish-white crystals. Solubility Practically insoluble…<\/p>\n","protected":false},"author":5,"featured_media":28942,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[174],"tags":[],"class_list":["post-28941","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\/28941","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=28941"}],"version-history":[{"count":4,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/28941\/revisions"}],"predecessor-version":[{"id":29701,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/28941\/revisions\/29701"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/28942"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=28941"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=28941"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=28941"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}

Time (min)<\/td>\n	Mobile phase A (per cent V\/V)<\/td>\n	Mobile phase B (per cent V\/V)<\/td>\n<\/tr>\n
0 – 2.7<\/td>\n	65<\/td>\n	35<\/td>\n<\/tr>\n
2.7 – 7<\/td>\n	65 \u2192 63<\/td>\n	35 \u2192 37<\/td>\n<\/tr>\n
7 – 10<\/td>\n	63 \u2192 10<\/td>\n	37 \u2192 90<\/td>\n<\/tr>\n
10 – 12<\/td>\n	10<\/td>\n	90<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n Flow rate\u00a0 \u00a01.5 mL\/min.<\/p>\n Detection Spectrophotometer at 242 nm, and for impurity I, at 290 nm.<\/p>\n Injection 20 \u03bcL of the test solution and reference solutions (a), (b) and (c).<\/p>\n Identification of impurities\u00a0 \u00a0Use the chromatogram supplied with testosterone for system suitability A CRS and the chromatogram obtained with reference solution (a) to identify the peaks due to impurities C, G and K; use the chromatogram obtained with reference solution (b) to identify the peak due to impurity I.<\/p>\n Relative retention\u00a0 \u00a0With reference to testosterone (retention time = about 4 min): impurity I = about 0.84; impurity K = about 0.86; impurity G = about 1.1; impurity C = about 1.3.<\/p>\n System suitability\u00a0 \u00a0Reference solution (a):<\/p>\n \u2014 peak-to-valley ratio: minimum 2.0, where H_{p<\/sub> = height above the baseline of the peak due to impurity G and<\/p>\n} H_{v<\/sub> = height above the baseline of the lowest point of the curve separating this peak from the peak due to testosterone.<\/p>\n} Calculation of percentage contents:<\/p>\n \u2014 for impurity I, use the concentration of impurity I in reference solution (b);<\/p>\n \u2014 for impurities other than I, use the concentration of testosterone in reference solution (c).<\/p>\n Limits:<\/p>\n \u2014 impurity C: maximum 0.3 per cent;<\/p>\n \u2014 impurity I at 290 nm: maximum 0.2 per cent;<\/p>\n \u2014 impurity K: maximum 0.15 per cent;<\/p>\n \u2014 unspecified impurities: for each impurity, maximum 0.10 per cent;<\/p>\n \u2014 total: maximum 0.6 per cent;<\/p>\n \u2014 reporting threshold: 0.05 per cent.<\/p>\n Loss on drying (2.2.32)<\/h3>\n Maximum 1.0 per cent, determined on 0.500 g by drying in an oven at 105 \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 5 \u03bcL of the test solution and reference solution (d).<\/p>\n Calculate the percentage content of C_{19<\/sub>H_{28<\/sub>O_{2<\/sub> taking into account the assigned content of testosterone for ID and assay CRS.<\/p>\n}}} STORAGE<\/h2>\n Protected from light.<\/p>\n IMPURITIES<\/h2>\n Specified impurities C, I, K.<\/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) A, B, E, G, H, J, L, M.<\/p>\n $\"Testosterone\"$ <\/p>\n A. androst-4-ene-3,17-dione (androstenedione),<\/p>\n $\"Testosterone\"$ <\/p>\n B. 3-ethoxyandrosta-3,5-dien-17-one (androstenedione ethylenolether),<\/p>\n $\"Testosterone\"$ <\/p>\n C. 17\u03b1-hydroxyandrost-4-en-3-one (17-epi-testosterone),<\/p>\n $\"Testosterone\"$ <\/p>\n E. 3-oxoandrost-4-en-17\u03b2-yl acetate (testosterone acetate),<\/p>\n $\"Testosterone\"$ <\/p>\n G. androsta-1,4-diene-3,17-dione (androstadienedione),<\/p>\n $\"Testosterone\"$ <\/p>\n H. 17\u03b2-hydroxyandrosta-1,4-dien-3-one (boldenone),<\/p>\n $\"Testosterone\"$ <\/p>\n I. 17\u03b2-hydroxyandrosta-4,6-dien-3-one (\u03946-testosterone),<\/p>\n $\"Testosterone\"$ <\/p>\n J. 3-methoxyandrosta-3,5-dien-17-one (androstenedione methylenolether),<\/p>\n $\"Testosterone\"$ <\/p>\n K. 17\u03b2-hydroxyandrosta-4,8-dien-3-one,<\/p>\n $\"Testosterone\"$ <\/p>\n L. 17\u03b2-hydroxyandrosta-4,9(11)-dien-3-one,<\/p>\n $\"Testosterone\"$ <\/p>\n M. 17\u03b2-hydroxyandrosta-4,8(14)-dien-3-one.<\/p>\n Ph Eur<\/p>\n","protected":false},"excerpt":{"rendered":" Edition: BP 2025 (Ph. Eur. 11.6 update) (Ph. Eur. monograph 1373) C19H28O2\u00a0 \u00a0 \u00a0 \u00a0288.4\u00a0 \u00a0 \u00a0 \u00a058-22-0 Action and use Androgen. Preparation Testosterone Implants Ph Eur DEFINITION 17\u03b2-Hydroxyandrost-4-en-3-one. Content 98.0 per cent to 102.0 per cent (dried substance). CHARACTERS Appearance White or almost white crystalline powder, or colourless or yellowish-white crystals. Solubility Practically insoluble…<\/p>\n","protected":false},"author":5,"featured_media":28942,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[174],"tags":[],"class_list":["post-28941","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\/28941","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=28941"}],"version-history":[{"count":4,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/28941\/revisions"}],"predecessor-version":[{"id":29701,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/28941\/revisions\/29701"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/28942"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=28941"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=28941"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=28941"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}

Appearance<\/h3>\nWhite or almost white crystalline powder, or colourless or yellowish-white crystals.<\/p>\n

Solubility<\/h3>\nPractically insoluble in water, freely soluble in ethanol (96 per cent) and in methylene chloride, practically insoluble in fatty oils.<\/p>\n

mp<\/h3>\nAbout 155 \u00b0C.<\/p>\n

IDENTIFICATION<\/h2>\nInfrared absorption spectrophotometry (2.2.24).<\/p>\nComparison testosterone for ID and assay CRS.<\/p>\n

TESTS<\/h2>\n

Specific optical rotation (2.2.7)<\/h3>\n+ 106 to + 114 (dried substance).<\/p>\nDissolve 0.250 g in anhydrous ethanol R and dilute to 25.0 mL with the same solvent.<\/p>\n

Loss on drying (2.2.32)<\/h3>\nMaximum 1.0 per cent, determined on 0.500 g by drying in an oven at 105 \u00b0C for 2 h.<\/p>\n

STORAGE<\/h2>\nProtected from light.<\/p>\n

Appearance<\/h3>\n
White or almost white crystalline powder, or colourless or yellowish-white crystals.<\/p>\n

Solubility<\/h3>\n
Practically insoluble in water, freely soluble in ethanol (96 per cent) and in methylene chloride, practically insoluble in fatty oils.<\/p>\n

mp<\/h3>\n
About 155 \u00b0C.<\/p>\n

IDENTIFICATION<\/h2>\n
Infrared absorption spectrophotometry (2.2.24).<\/p>\n
Comparison testosterone for ID and assay CRS.<\/p>\n

Specific optical rotation (2.2.7)<\/h3>\n
+ 106 to + 114 (dried substance).<\/p>\n
Dissolve 0.250 g in anhydrous ethanol R and dilute to 25.0 mL with the same solvent.<\/p>\n

Loss on drying (2.2.32)<\/h3>\n
Maximum 1.0 per cent, determined on 0.500 g by drying in an oven at 105 \u00b0C for 2 h.<\/p>\n

STORAGE<\/h2>\n
Protected from light.<\/p>\n