{"id":25715,"date":"2025-11-04T16:39:21","date_gmt":"2025-11-04T09:39:21","guid":{"rendered":"https:\/\/nhathuocngocanh.com\/bp\/?p=25715"},"modified":"2025-11-04T16:41:00","modified_gmt":"2025-11-04T09:41:00","slug":"nandrolone-decanoate","status":"publish","type":"post","link":"https:\/\/nhathuocngocanh.com\/bp\/nandrolone-decanoate\/","title":{"rendered":"Nandrolone Decanoate"},"content":{"rendered":"

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

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

Anabolic steroid; androgen. Ph Eur<\/p>\n

DEFINITION<\/h2>\n
3-Oxoestr-4-en-17\u03b2-yl decanoate.<\/p>\n
Content<\/strong><\/p>\n
97.0 per cent to 103.0 per cent (dried substance).<\/p>\n
CHARACTERS<\/h2>\n
Appearance<\/h3>\n
White or almost white, crystalline powder.<\/p>\n
Solubility<\/h3>\n
Practically insoluble in water, very soluble in ethanol (96 per cent) and in methylene chloride.<\/p>\n
IDENTIFICATION<\/h2>\n
A. Melting point (2.2.14): 34 \u00b0C to 38 \u00b0C.<\/p>\n
B. Infrared absorption spectrophotometry (2.2.24).<\/p>\n
Comparison\u00a0 nandrolone decanoate CRS.<\/p>\n
TESTS<\/h2>\n
Appearance of solution<\/h3>\n
The solution is clear (2.2.1) and not more intensely coloured than reference solution Y6 (2.2.2, Method II). Dissolve 0.20 g in 10 mL of methanol R.<\/p>\n
Specific optical rotation (2.2.7)<\/strong><\/p>\n
+ 35.0 to + 40.0 (dried substance).<\/p>\n
Dissolve 0.200 g in anhydrous ethanol R and dilute to 20.0 mL with the same solvent.<\/p>\n
Impurities A, B, C<\/h3>\n
Thin-layer chromatography (2.2.27).<\/p>\n
Test solution\u00a0 Dissolve 50 mg of the substance to be examined in methylene chloride R and dilute to 5.0 mL with the same solvent.<\/p>\n
Reference solution (a)\u00a0 Dilute 1.0 mL of the test solution to 10.0 mL with methylene chloride R. Reference solution (b)\u00a0 Dilute 1.0 mL of reference solution (a) to 10.0 mL with methylene chloride R. Reference solution (c)\u00a0 Dilute 1.0 mL of reference solution (a) to 20.0 mL with methylene chloride R.<\/p>\n
Reference solution (d)\u00a0 Dissolve 5 mg of nandrolone decanoate for system suitability CRS (containing impurities A, B, C) in 0.5 mL of methylene chloride R.<\/p>\n
Plate\u00a0 TLC silica gel plate R.<\/p>\n
Mobile phase\u00a0 acetone R, heptane R (30:70 V\/V).<\/p>\n
Application\u00a0 10 \u00b5L of the test solution and reference solutions (b), (c) and (d).<\/p>\n
Development\u00a0 Over 2\/3 of the plate.<\/p>\n
Drying\u00a0 In air.<\/p>\n
Detection\u00a0 Treat with alcoholic solution of sulfuric acid R and heat at 130 \u00b0C until the spots appear. Examine in ultraviolet light at 366 nm.<\/p>\n
Retardation factors\u00a0 Nandrolone decanoate = about 0.37; impurity A = about 0.45; impurity B = about 0.55; impurity C = about 0.58.<\/p>\n
System suitability\u00a0 Reference solution (d):<\/p>\n
\u2014 the chromatogram shows 4 clearly separated spots.<\/p>\n
Limits:<\/p>\n
\u2014 impurity A: any spot due to impurity A is not more intense than the principal spot in the chromatogram obtained with reference solution (b) (1.0 per cent);<\/p>\n
\u2014 impurities B, C: any spot due to impurity B or C is not more intense than the principal spot in the chromatogram obtained with reference solution (c) (0.5 per cent).<\/p>\n
Related substances<\/h3>\n
Liquid chromatography (2.2.29).<\/p>\n
Test solution\u00a0 Dissolve 25 mg of the substance to be examined in methanol R and dilute to 10.0 mL with the same solvent.<\/p>\n
Reference solution (a)\u00a0 Dilute 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 (b)\u00a0 Dissolve 5 mg of nandrolone decanoate for peak identification CRS (containing impurities D, F, G, H, I, K, L) in methanol R and dilute to 2.0 mL with the same solvent.<\/p>\n
Column:<\/p>\n
\u2014 size: l = 0.15 m, \u00d8 = 3.9 mm;<\/p>\n
\u2014 stationary phase: end-capped octadecylsilyl silica gel for chromatography R (5 \u00b5m).<\/p>\n
Mobile phase:<\/p>\n
\u2014 mobile phase A: water for chromatography R;<\/p>\n
\u2014 mobile phase B: acetonitrile R;<\/p>\n\n\n\n\n\n\n\n
Time (min)<\/strong><\/td>\n Mobile phase A (per cent V\/V)<\/strong><\/td>\n Mobile phase B (per cent V\/V)<\/strong><\/td>\n<\/tr>\n
0 – 5<\/td>\n 35<\/td>\n 65<\/td>\n<\/tr>\n
5 – 40<\/td>\n 35 \u2192 0<\/td>\n 65 \u2192 100<\/td>\n<\/tr>\n
40 – 75<\/td>\n 0<\/td>\n 100<\/td>\n<\/tr>\n
75 – 80<\/td>\n 0 \u2192 35<\/td>\n 100 \u2192 65<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n
Flow rate\u00a0 1.0 mL\/min.<\/p>\n
Detection\u00a0 Spectrophotometer at 254 nm.<\/p>\n
Injection\u00a0 20 \u00b5L.<\/p>\n
Relative retention\u00a0 With reference to nandrolone decanoate (retention time = about 30 min): impurity D = about 0.05; impurity F = about 0.6; impurity K = about 0.7; impurity L = about 0.9; impurity G = about 0.97; impurity H = about 1.1; impurity I = about 1.2.<\/p>\n
System suitability\u00a0 Reference solution (b):<\/p>\n
\u2014 peak-to-valley ratio: minimum 1.5, where Hp = height above the baseline of the peak due to impurity G and Hv = height above the baseline of the lowest point of the curve separating this peak from the peak due to nandrolone decanoate.<\/p>\n
Limits:<\/p>\n
\u00a0\u2014 correction factors: for the calculation of contents, multiply the peak areas of the following impurities by the corresponding correction factor: impurity D = 0.5; impurity F = 0.6; impurity H = 1.1; impurity I = 1.3; impurity K = 0.8;<\/p>\n
\u2014 impurities D, F, G, H, I, K, L: for each impurity, not more than 5 times the area of the principal peak in the chromatogram obtained with reference solution (a) (0.5 per cent);<\/p>\n
\u2014 unspecified impurities: for each impurity, not more than the area of the principal peak in the chromatogram obtained with reference solution (a) (0.10 per cent);<\/p>\n
\u2014 total: not more than 15 times the area of the principal peak in the chromatogram obtained with reference solution (a) (1.5 per cent);<\/p>\n
\u2014 disregard limit: 0.5 times the area of the principal peak in the chromatogram obtained with reference solution (a) (0.05 per cent).<\/p>\n
Loss on drying (2.2.32)<\/strong><\/p>\n
Maximum 0.5 per cent, determined on 1.000 g by drying in vacuo at a pressure not exceeding 0.7 kPa for 4 h.<\/p>\n
Sulfated ash (2.4.14)<\/strong><\/p>\n
Maximum 0.1 per cent, determined on 1.0 g.<\/p>\n
ASSAY<\/h2>\n
Dissolve 10.0 mg in anhydrous ethanol R and dilute to 100.0 mL with the same solvent. Dilute 5.0 mL of this solution to 50.0 mL with anhydrous ethanol R. Measure the absorbance (2.2.25) at the absorption maximum at 240 nm. Calculate the content of C28H44O3 taking the specific absorbance to be 407.<\/p>\n
STORAGE<\/h2>\n
Under nitrogen, protected from light and at a temperature of 2 \u00b0C to 8 \u00b0C.<\/p>\n
IMPURITIES<\/h2>\n
Specified impurities\u00a0 A, B, C, D, F, G, H, I, K, L.<\/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.
\nControl of impurities in substances for pharmaceutical use)\u00a0 E, J.<\/p>\n
A. 3-oxo-5\u03b1-estran-17\u03b2-yl decanoate,<\/p>\n
B. 3-methoxyestra-1,3,5(10)-trien-17\u03b2-yl decanoate,<\/p>\n
C. 3,3-dimethoxy-5\u03b1-estran-17\u03b2-yl decanoate,<\/p>\n
D. 17\u03b2-hydroxyestr-4-en-3-one,<\/p>\n
E. 6\u03b1-hydroxy-3-oxoestr-4-en-17\u03b2-yl decanoate,<\/p>\n
F. 3,6-dioxoestr-4-en-17\u03b2-yl decanoate,<\/p>\n
G. 3-oxoestra-4,8(14)-dien-17\u03b2-yl decanoate,<\/p>\n
H. 3-oxoestr-4-en-17\u03b2-yl undecanoate,<\/p>\n
I. 3-oxoestr-4-en-17\u03b2-yl dodecanoate,<\/p>\n
J. 5\u03b1-estr-3-ene-3,17\u03b2-diyl didecanoate,<\/p>\n
K. 3-oxoestr-4-en-17\u03b2-yl octanoate,<\/p>\n
L. 3-oxoestr-4-en-17\u03b2-yl nonanoate.<\/p>\n
\n
Ph Eur<\/p>\n","protected":false},"excerpt":{"rendered":"
Edition: BP 2025 (Ph. Eur. 11.6 update) Action and use Anabolic steroid; androgen. Ph Eur DEFINITION 3-Oxoestr-4-en-17\u03b2-yl decanoate. Content 97.0 per cent to 103.0 per cent (dried substance). CHARACTERS Appearance White or almost white, crystalline powder. Solubility Practically insoluble in water, very soluble in ethanol (96 per cent) and in methylene chloride. IDENTIFICATION A. Melting…<\/p>\n","protected":false},"author":5,"featured_media":25726,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[174],"tags":[],"class_list":["post-25715","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\/25715","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=25715"}],"version-history":[{"count":3,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/25715\/revisions"}],"predecessor-version":[{"id":25729,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/25715\/revisions\/25729"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/25726"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=25715"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=25715"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=25715"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}

Time (min)<\/strong><\/td>\n	Mobile phase A (per cent V\/V)<\/strong><\/td>\n	Mobile phase B (per cent V\/V)<\/strong><\/td>\n<\/tr>\n
0 – 5<\/td>\n	35<\/td>\n	65<\/td>\n<\/tr>\n
5 – 40<\/td>\n	35 \u2192 0<\/td>\n	65 \u2192 100<\/td>\n<\/tr>\n
40 – 75<\/td>\n	0<\/td>\n	100<\/td>\n<\/tr>\n
75 – 80<\/td>\n	0 \u2192 35<\/td>\n	100 \u2192 65<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n Flow rate\u00a0 1.0 mL\/min.<\/p>\n Detection\u00a0 Spectrophotometer at 254 nm.<\/p>\n Injection\u00a0 20 \u00b5L.<\/p>\n Relative retention\u00a0 With reference to nandrolone decanoate (retention time = about 30 min): impurity D = about 0.05; impurity F = about 0.6; impurity K = about 0.7; impurity L = about 0.9; impurity G = about 0.97; impurity H = about 1.1; impurity I = about 1.2.<\/p>\n System suitability\u00a0 Reference solution (b):<\/p>\n \u2014 peak-to-valley ratio: minimum 1.5, where Hp = height above the baseline of the peak due to impurity G and Hv = height above the baseline of the lowest point of the curve separating this peak from the peak due to nandrolone decanoate.<\/p>\n Limits:<\/p>\n \u00a0\u2014 correction factors: for the calculation of contents, multiply the peak areas of the following impurities by the corresponding correction factor: impurity D = 0.5; impurity F = 0.6; impurity H = 1.1; impurity I = 1.3; impurity K = 0.8;<\/p>\n \u2014 impurities D, F, G, H, I, K, L: for each impurity, not more than 5 times the area of the principal peak in the chromatogram obtained with reference solution (a) (0.5 per cent);<\/p>\n \u2014 unspecified impurities: for each impurity, not more than the area of the principal peak in the chromatogram obtained with reference solution (a) (0.10 per cent);<\/p>\n \u2014 total: not more than 15 times the area of the principal peak in the chromatogram obtained with reference solution (a) (1.5 per cent);<\/p>\n \u2014 disregard limit: 0.5 times the area of the principal peak in the chromatogram obtained with reference solution (a) (0.05 per cent).<\/p>\n Loss on drying (2.2.32)<\/strong><\/p>\n Maximum 0.5 per cent, determined on 1.000 g by drying in vacuo at a pressure not exceeding 0.7 kPa for 4 h.<\/p>\n Sulfated ash (2.4.14)<\/strong><\/p>\n Maximum 0.1 per cent, determined on 1.0 g.<\/p>\n ASSAY<\/h2>\n Dissolve 10.0 mg in anhydrous ethanol R and dilute to 100.0 mL with the same solvent. Dilute 5.0 mL of this solution to 50.0 mL with anhydrous ethanol R. Measure the absorbance (2.2.25) at the absorption maximum at 240 nm. Calculate the content of C28H44O3 taking the specific absorbance to be 407.<\/p>\n STORAGE<\/h2>\n Under nitrogen, protected from light and at a temperature of 2 \u00b0C to 8 \u00b0C.<\/p>\n IMPURITIES<\/h2>\n Specified impurities\u00a0 A, B, C, D, F, G, H, I, K, L.<\/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. \nControl of impurities in substances for pharmaceutical use)\u00a0 E, J.<\/p>\n A. 3-oxo-5\u03b1-estran-17\u03b2-yl decanoate,<\/p>\n B. 3-methoxyestra-1,3,5(10)-trien-17\u03b2-yl decanoate,<\/p>\n C. 3,3-dimethoxy-5\u03b1-estran-17\u03b2-yl decanoate,<\/p>\n D. 17\u03b2-hydroxyestr-4-en-3-one,<\/p>\n E. 6\u03b1-hydroxy-3-oxoestr-4-en-17\u03b2-yl decanoate,<\/p>\n F. 3,6-dioxoestr-4-en-17\u03b2-yl decanoate,<\/p>\n G. 3-oxoestra-4,8(14)-dien-17\u03b2-yl decanoate,<\/p>\n H. 3-oxoestr-4-en-17\u03b2-yl undecanoate,<\/p>\n I. 3-oxoestr-4-en-17\u03b2-yl dodecanoate,<\/p>\n J. 5\u03b1-estr-3-ene-3,17\u03b2-diyl didecanoate,<\/p>\n K. 3-oxoestr-4-en-17\u03b2-yl octanoate,<\/p>\n L. 3-oxoestr-4-en-17\u03b2-yl nonanoate.<\/p>\n \n Ph Eur<\/p>\n","protected":false},"excerpt":{"rendered":" Edition: BP 2025 (Ph. Eur. 11.6 update) Action and use Anabolic steroid; androgen. Ph Eur DEFINITION 3-Oxoestr-4-en-17\u03b2-yl decanoate. Content 97.0 per cent to 103.0 per cent (dried substance). CHARACTERS Appearance White or almost white, crystalline powder. Solubility Practically insoluble in water, very soluble in ethanol (96 per cent) and in methylene chloride. IDENTIFICATION A. Melting…<\/p>\n","protected":false},"author":5,"featured_media":25726,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[174],"tags":[],"class_list":["post-25715","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\/25715","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=25715"}],"version-history":[{"count":3,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/25715\/revisions"}],"predecessor-version":[{"id":25729,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/25715\/revisions\/25729"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/25726"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=25715"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=25715"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=25715"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}

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

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

IDENTIFICATION<\/h2>\nA. Melting point (2.2.14): 34 \u00b0C to 38 \u00b0C.<\/p>\nB. Infrared absorption spectrophotometry (2.2.24).<\/p>\nComparison\u00a0 nandrolone decanoate CRS.<\/p>\n

TESTS<\/h2>\n

STORAGE<\/h2>\nUnder nitrogen, protected from light and at a temperature of 2 \u00b0C to 8 \u00b0C.<\/p>\n

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

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

IDENTIFICATION<\/h2>\n
A. Melting point (2.2.14): 34 \u00b0C to 38 \u00b0C.<\/p>\n
B. Infrared absorption spectrophotometry (2.2.24).<\/p>\n
Comparison\u00a0 nandrolone decanoate CRS.<\/p>\n

STORAGE<\/h2>\n
Under nitrogen, protected from light and at a temperature of 2 \u00b0C to 8 \u00b0C.<\/p>\n