{"id":14022,"date":"2025-10-14T15:29:15","date_gmt":"2025-10-14T08:29:15","guid":{"rendered":"https:\/\/nhathuocngocanh.com\/bp\/?p=14022"},"modified":"2025-10-14T15:29:15","modified_gmt":"2025-10-14T08:29:15","slug":"estradiol-valerate","status":"publish","type":"post","link":"https:\/\/nhathuocngocanh.com\/bp\/estradiol-valerate\/","title":{"rendered":"Estradiol Valerate"},"content":{"rendered":"

(Ph. Eur. monograph 1614)<\/p>\n

C_{23<\/sub>H_{32<\/sub>O_{3<\/sub> 356.5 979-32-8<\/p>\n}}}

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

Estrogen.<\/p>\n

DEFINITION<\/h2>\n
3-Hydroxyestra-1,3,5(10)-trien-17\u03b2-yl pentanoate.<\/p>\n
Content<\/h3>\n
97.5 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 crystals.<\/p>\n
Solubility<\/h3>\n
Practically insoluble in water, freely soluble in methylene chloride, soluble in ethanol (96 per cent).<\/p>\n
IDENTIFICATION<\/h2>\n
A. Infrared absorption spectrophotometry (2.2.24).<\/p>\n
Comparison: estradiol valerate CRS.<\/p>\n
B. Examine the chromatograms obtained in the assay.<\/p>\n
Results: The principal peak in the chromatogram obtained with test solution (b) is similar in retention time and size to the principal peak in the chromatogram obtained with reference solution (c).<\/p>\n
TESTS<\/h2>\n
Solution S<\/h3>\n
Dissolve 0.500 g in methanol R and dilute to 20.0 mL with the same solvent.<\/p>\n
Appearance of solution<\/h3>\n
Solution S is clear (2.2.1) and colourless (2.2.2, Method II).<\/p>\n
Specific optical rotation (2.2.7)<\/h3>\n
+ 41 to + 47 (dried substance), determined on solution S.<\/p>\n
Related substances<\/h3>\n
Liquid chromatography (2.2.29).<\/p>\n
Test solution (a): Dissolve 50.0 mg of the substance to be examined in acetonitrile R1 and dilute to 10.0 mL with the same solvent.<\/p>\n
Test solution (b): Dilute 5.0 mL of test solution (a) to 20.0 mL with acetonitrile R1.<\/p>\n
Reference solution (a): Dissolve 3 mg of estradiol valerate for system suitability CRS (containing impurities A, C, D and E) in acetonitrile R1 and dilute to 1.0 mL with the same solvent.<\/p>\n
Reference solution (b): Dilute 1.0 mL of test solution (a) to 100.0 mL with acetonitrile R1. Dilute 1.0 mL of this solution to 10.0 mL with acetonitrile R1.<\/p>\n
Reference solution (c): Dissolve 50.0 mg of estradiol valerate CRS in acetonitrile R1 and dilute to 10.0 mL with the same solvent. Dilute 5.0 mL of the solution to 20.0 mL with acetonitrile R1.<\/p>\n
Column:<\/p>\n
\u2014 size: l = 0.10 m, \u00d8 = 4.6 mm;<\/p>\n
\u2014 stationary phase: end-capped solid core alkylsilyl silica gel for chromatography R (2.6 \u03bcm).<\/p>\n
Mobile phase:<\/p>\n
\u2014 mobile phase A: water R;<\/p>\n
\u2014 mobile phase B: acetonitrile R1;<\/p>\n\n\n\n\n\n\n\n
Time<\/strong><\/p>\n
(min)<\/strong><\/td>\n
Mobile phase A<\/strong><\/p>\n
(per cent V\/V)<\/strong><\/td>\n
Mobile phase B<\/strong><\/p>\n
(per cent\u00a0<\/strong><\/td>\n<\/tr>\n
0 – 1<\/td>\n 48<\/td>\n 52<\/td>\n<\/tr>\n
1 – 10<\/td>\n 48 \u2192 35<\/td>\n 52 \u2192 65<\/td>\n<\/tr>\n
10 – 17.5<\/td>\n 35 \u2192 0<\/td>\n 65 \u2192 100<\/td>\n<\/tr>\n
65 \u2192 100<\/td>\n 0<\/td>\n 100<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n
Flow rate: 2.0 mL\/min.<\/p>\n
Detection: Spectrophotometer at 220 nm.<\/p>\n
Injection: 5 \u03bcL of test solution (a) and reference solutions (a) and (b).<\/p>\n
Identification of impurities: Use the chromatogram supplied with estradiol valerate for system suitability CRS and the chromatogram obtained with reference solution (a) to identify the peaks due to impurities A, C, D and E.<\/p>\n
Relative retention: With reference to estradiol valerate (retention time = about 9 min): impurity A = about 0.1; impurity C = about 0.9; impurity D = about 1.3; impurity E = about 1.7.<\/p>\n
System suitability: Reference solution (a):<\/p>\n
\u2014 resolution: minimum 2.5 between the peaks due to impurity C and estradiol valerate.<\/p>\n
Calculation of percentage contents:<\/p>\n
\u2014 correction factor: multiply the peak area of impurity C by 0.5;<\/p>\n
\u2014 for each impurity, use the concentration of estradiol valerate in reference solution (b).<\/p>\n
Limits:<\/p>\n
\u2014 impurity D: maximum 0.4 per cent;<\/p>\n
\u2014 impurities A, C: for each impurity, maximum 0.2 per cent;<\/p>\n
\u2014 impurity E: maximum 0.15 per cent;<\/p>\n
\u2014 unspecified impurities: for each impurity, maximum 0.10 per cent;<\/p>\n
\u2014 total: maximum 0.5 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 3 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: Test solution (b) and reference solution (c).<\/p>\n
Calculate the percentage content of C_{23<\/sub>H_{32<\/sub>O_{3<\/sub> taking into account the assigned content of estradiol valerate CRS.<\/p>\n}}}
STORAGE<\/h2>\n
Protected from light.<\/p>\n
IMPURITIES<\/h2>\n
Specified impurities A, C, D, E.<\/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) B, F, G, H, I, J.<\/p>\n
$\"Estradiol$ <\/p>\n
A. estra-1,3,5(10)-triene-3,17\u03b2-diol (estradiol),<\/p>\n
$\"Estradiol$ <\/p>\n
B. 17\u03b2-hydroxyestra-1,3,5(10)-trien-3-yl pentanoate,<\/p>\n
$\"Estradiol$ <\/p>\n
C. 3-hydroxyestra-1,3,5(10),9(11)-tetraen-17\u03b2-yl pentanoate,<\/p>\n
$\"Estradiol$ <\/p>\n
D. 3-hydroxy-4-methylestra-1,3,5(10)-trien-17\u03b2-yl pentanoate,<\/p>\n
$\"Estradiol$ <\/p>\n
E. estra-1,3,5(10)-trien-3,17\u03b2-diyl dipentanoate,<\/p>\n
$\"Estradiol$ <\/p>\n
F. 3-hydroxyestra-1,3,5(10)-trien-17\u03b2-yl butanoate,<\/p>\n
$\"Estradiol$ <\/p>\n
G. 3-hydroxyestra-1,3,5(10),6-tetraen-17\u03b2-yl pentanoate,<\/p>\n
$\"Estradiol$ <\/p>\n
H. 3-hydroxy-2-pentanoylestra-1,3,5(10)-trien-17\u03b2-yl pentanoate,<\/p>\n
$\"Estradiol$ <\/p>\n
I. (1S,3aS,3bR,10aR,10bS,13S,13aS,15aS,18bS,20aS)-13a,17,17,20a-tetramethyl-2,3,3a,3b,4,5,9,10,10a,10b,11,12,13,13a,14,15,15a,17,18b,19,20,20a-docosahydro-1H-bis(cyclopenta[5,6]naphtho)[1,2-b:2\u02b9,1\u02b9-i]xanthene-1,13-diyl dipentanoate,<\/p>\n
$\"Estradiol$ <\/p>\n
J. 3-methoxyestra-1,3,5(10)-trien-17\u03b2-yl pentanoate.<\/p>\n","protected":false},"excerpt":{"rendered":"
(Ph. Eur. monograph 1614) C23H32O3 356.5 979-32-8 Action and use Estrogen. DEFINITION 3-Hydroxyestra-1,3,5(10)-trien-17\u03b2-yl pentanoate. Content 97.5 per cent to 102.0 per cent (dried substance). CHARACTERS Appearance White or almost white, crystalline powder or colourless crystals. Solubility Practically insoluble in water, freely soluble in methylene chloride, soluble in ethanol (96 per cent). IDENTIFICATION A. Infrared absorption…<\/p>\n","protected":false},"author":4,"featured_media":14062,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[174],"tags":[],"class_list":["post-14022","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\/14022","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=14022"}],"version-history":[{"count":3,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/14022\/revisions"}],"predecessor-version":[{"id":14087,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/14022\/revisions\/14087"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/14062"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=14022"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=14022"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=14022"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}

Time<\/strong><\/p>\n (min)<\/strong><\/td>\n	Mobile phase A<\/strong><\/p>\n (per cent V\/V)<\/strong><\/td>\n	Mobile phase B<\/strong><\/p>\n (per cent\u00a0<\/strong><\/td>\n<\/tr>\n
0 – 1<\/td>\n	48<\/td>\n	52<\/td>\n<\/tr>\n
1 – 10<\/td>\n	48 \u2192 35<\/td>\n	52 \u2192 65<\/td>\n<\/tr>\n
10 – 17.5<\/td>\n	35 \u2192 0<\/td>\n	65 \u2192 100<\/td>\n<\/tr>\n
65 \u2192 100<\/td>\n	0<\/td>\n	100<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n Flow rate: 2.0 mL\/min.<\/p>\n Detection: Spectrophotometer at 220 nm.<\/p>\n Injection: 5 \u03bcL of test solution (a) and reference solutions (a) and (b).<\/p>\n Identification of impurities: Use the chromatogram supplied with estradiol valerate for system suitability CRS and the chromatogram obtained with reference solution (a) to identify the peaks due to impurities A, C, D and E.<\/p>\n Relative retention: With reference to estradiol valerate (retention time = about 9 min): impurity A = about 0.1; impurity C = about 0.9; impurity D = about 1.3; impurity E = about 1.7.<\/p>\n System suitability: Reference solution (a):<\/p>\n \u2014 resolution: minimum 2.5 between the peaks due to impurity C and estradiol valerate.<\/p>\n Calculation of percentage contents:<\/p>\n \u2014 correction factor: multiply the peak area of impurity C by 0.5;<\/p>\n \u2014 for each impurity, use the concentration of estradiol valerate in reference solution (b).<\/p>\n Limits:<\/p>\n \u2014 impurity D: maximum 0.4 per cent;<\/p>\n \u2014 impurities A, C: for each impurity, maximum 0.2 per cent;<\/p>\n \u2014 impurity E: maximum 0.15 per cent;<\/p>\n \u2014 unspecified impurities: for each impurity, maximum 0.10 per cent;<\/p>\n \u2014 total: maximum 0.5 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 3 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: Test solution (b) and reference solution (c).<\/p>\n Calculate the percentage content of C_{23<\/sub>H_{32<\/sub>O_{3<\/sub> taking into account the assigned content of estradiol valerate CRS.<\/p>\n}}} STORAGE<\/h2>\n Protected from light.<\/p>\n IMPURITIES<\/h2>\n Specified impurities A, C, D, E.<\/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) B, F, G, H, I, J.<\/p>\n $\"Estradiol$ <\/p>\n A. estra-1,3,5(10)-triene-3,17\u03b2-diol (estradiol),<\/p>\n $\"Estradiol$ <\/p>\n B. 17\u03b2-hydroxyestra-1,3,5(10)-trien-3-yl pentanoate,<\/p>\n $\"Estradiol$ <\/p>\n C. 3-hydroxyestra-1,3,5(10),9(11)-tetraen-17\u03b2-yl pentanoate,<\/p>\n $\"Estradiol$ <\/p>\n D. 3-hydroxy-4-methylestra-1,3,5(10)-trien-17\u03b2-yl pentanoate,<\/p>\n $\"Estradiol$ <\/p>\n E. estra-1,3,5(10)-trien-3,17\u03b2-diyl dipentanoate,<\/p>\n $\"Estradiol$ <\/p>\n F. 3-hydroxyestra-1,3,5(10)-trien-17\u03b2-yl butanoate,<\/p>\n $\"Estradiol$ <\/p>\n G. 3-hydroxyestra-1,3,5(10),6-tetraen-17\u03b2-yl pentanoate,<\/p>\n $\"Estradiol$ <\/p>\n H. 3-hydroxy-2-pentanoylestra-1,3,5(10)-trien-17\u03b2-yl pentanoate,<\/p>\n $\"Estradiol$ <\/p>\n I. (1S,3aS,3bR,10aR,10bS,13S,13aS,15aS,18bS,20aS)-13a,17,17,20a-tetramethyl-2,3,3a,3b,4,5,9,10,10a,10b,11,12,13,13a,14,15,15a,17,18b,19,20,20a-docosahydro-1H-bis(cyclopenta[5,6]naphtho)[1,2-b:2\u02b9,1\u02b9-i]xanthene-1,13-diyl dipentanoate,<\/p>\n $\"Estradiol$ <\/p>\n J. 3-methoxyestra-1,3,5(10)-trien-17\u03b2-yl pentanoate.<\/p>\n","protected":false},"excerpt":{"rendered":" (Ph. Eur. monograph 1614) C23H32O3 356.5 979-32-8 Action and use Estrogen. DEFINITION 3-Hydroxyestra-1,3,5(10)-trien-17\u03b2-yl pentanoate. Content 97.5 per cent to 102.0 per cent (dried substance). CHARACTERS Appearance White or almost white, crystalline powder or colourless crystals. Solubility Practically insoluble in water, freely soluble in methylene chloride, soluble in ethanol (96 per cent). IDENTIFICATION A. Infrared absorption…<\/p>\n","protected":false},"author":4,"featured_media":14062,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[174],"tags":[],"class_list":["post-14022","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\/14022","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=14022"}],"version-history":[{"count":3,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/14022\/revisions"}],"predecessor-version":[{"id":14087,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/14022\/revisions\/14087"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/14062"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=14022"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=14022"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=14022"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}

Content<\/h3>\n97.5 per cent to 102.0 per cent (dried substance).<\/p>\n

CHARACTERS<\/h2>\n

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

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

TESTS<\/h2>\n

Solution S<\/h3>\nDissolve 0.500 g in methanol R and dilute to 20.0 mL with the same solvent.<\/p>\n

Appearance of solution<\/h3>\nSolution S is clear (2.2.1) and colourless (2.2.2, Method II).<\/p>\n

Specific optical rotation (2.2.7)<\/h3>\n+ 41 to + 47 (dried substance), determined on solution S.<\/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 3 h.<\/p>\n

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

Content<\/h3>\n
97.5 per cent to 102.0 per cent (dried substance).<\/p>\n

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

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

Solution S<\/h3>\n
Dissolve 0.500 g in methanol R and dilute to 20.0 mL with the same solvent.<\/p>\n

Appearance of solution<\/h3>\n
Solution S is clear (2.2.1) and colourless (2.2.2, Method II).<\/p>\n

Specific optical rotation (2.2.7)<\/h3>\n
+ 41 to + 47 (dried substance), determined on solution S.<\/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 3 h.<\/p>\n

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