{"id":994,"date":"2025-09-17T10:43:59","date_gmt":"2025-09-17T03:43:59","guid":{"rendered":"https:\/\/nhathuocngocanh.com\/bp\/?p=994"},"modified":"2025-10-02T09:23:25","modified_gmt":"2025-10-02T02:23:25","slug":"fenofibrate","status":"publish","type":"post","link":"https:\/\/nhathuocngocanh.com\/bp\/fenofibrate\/","title":{"rendered":"Fenofibrate"},"content":{"rendered":"

(Ph. Eur. monograph 1322)<\/p>\n

C_{20<\/sub>H_{21<\/sub>ClO_{4<\/sub>\u00a0 \u00a0 \u00a0 360.8\u00a0 \u00a0 \u00a0 49562-28-9<\/p>\n}}}

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

Fibrate; lipid-regulating drug.<\/p>\n

Preparations<\/strong><\/p>\n

Fenofibrate Capsules<\/p>\n

Fenofibrate Tablets<\/p>\n

DEFINITION<\/h2>\n
1-Methylethyl 2-[4-(4-chlorobenzoyl)phenoxy]-2-methylpropanoate.<\/p>\n
Content<\/h3>\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.<\/p>\n
Solubility<\/h3>\n
Practically insoluble in water, very soluble in methylene chloride, slightly soluble in ethanol (96 per cent).<\/p>\n
IDENTIFICATION<\/h2>\n
A. Melting point (2.2.14): 79 \u00b0C to 82 \u00b0C.<\/p>\n
B. Infrared absorption spectrophotometry (2.2.24).<\/p>\n
Comparison fenofibrate CRS.<\/p>\n
TESTS<\/h2>\n
Solution S<\/h3>\n
To 5.0 g, add 25 mL of distilled water R and heat at 50 \u00b0C for 10 min. Cool and dilute to 50.0 mL with distilled water R. Filter. Use the filtrate as solution S.<\/p>\n
Appearance of solution<\/h3>\n
The solution is clear (2.2.1) and not more intensely coloured than reference solution BY6 (2.2.2, Method II).<\/p>\n
Dissolve 0.50 g in acetone R and dilute to 10.0 mL with the same solvent.<\/p>\n
Acidity<\/h3>\n
Dissolve 1.0 g in 50 mL of ethanol (96 per cent) R previously neutralised using 0.2 mL of phenolphthalein solution R1. Not more than 0.2 mL of 0.1 M sodium hydroxide is required to change the colour of the indicator to pink.<\/p>\n
Related substances<\/h3>\n
Liquid chromatography (2.2.29).<\/p>\n
Test solution: Dissolve 0.100 g of the substance to be examined in the mobile phase and dilute to 100.0 mL with the mobile phase.<\/p>\n
Reference solution (a): Dissolve 25.0 mg of fenofibrate CRS in the mobile phase and dilute to 25.0 mL with the mobile phase.<\/p>\n
Reference solution (b): Dissolve 5.0 mg of fenofibrate CRS, 5.0 mg of fenofibrate impurity A CRS, 5.0 mg of fenofibrate impurity B CRS and 10.0 mg of fenofibrate impurity G CRS in the mobile phase and dilute to 100.0 mL with the mobile phase. Dilute 1.0 mL of the solution to 50.0 mL with the mobile phase.<\/p>\n
Column:<\/p>\n
\u2014 size: l = 0.25 m, \u00d8 = 4.0 mm;<\/p>\n
\u2014 stationary phase: octadecylsilyl silica gel for chromatography R (5 \u03bcm).<\/p>\n
Mobile phase Mix 30 volumes of water R acidified to pH 2.5 with phosphoric acid R and 70 volumes of acetonitrile R.<\/p>\n
Flow rate: 1 mL\/min.<\/p>\n
Detection: Spectrophotometer at 286 nm.<\/p>\n
Injection: 20 \u03bcL of the test solution and reference solution (b).<\/p>\n
Run time: Twice the retention time of fenofibrate.<\/p>\n
Identification of impurities: Use the chromatogram obtained with reference solution (b) to identify the peaks due to impurities A, B and G.<\/p>\n
Relative retention: With reference to fenofibrate (retention time = about 10 min): impurity A = about 0.34; impurity B = about 0.36; impurity G = about 1.35.<\/p>\n
System suitability: Reference solution (b):<\/p>\n
\u2014 resolution: minimum 1.5 between the peaks due to impurities A and B.<\/p>\n
Limits:<\/p>\n
\u2014 impurities A, B: for each impurity, not more than 1.5 times the area of the corresponding peak in the chromatogram obtained with reference solution (b) (0.15 per cent);<\/p>\n
\u2014 impurity G: not more than the area of the corresponding peak in the chromatogram obtained with reference solution (b) (0.2 per cent);<\/p>\n
\u2014 unspecified impurities: for each impurity, not more than the area of the peak due to fenofibrate in the chromatogram obtained with reference solution (b) (0.10 per cent);<\/p>\n
\u2014 total: not more than 5 times the area of the peak due to fenofibrate in the chromatogram obtained with reference solution (b) (0.5 per cent);<\/p>\n
\u2014 disregard limit: 0.5 times the area of the peak due to fenofibrate in the chromatogram obtained with reference solution (b) (0.05 per cent).<\/p>\n
Halides expressed as chlorides (2.4.4)<\/h3>\n
Maximum 100 ppm.<\/p>\n
To 5 mL of solution S add 10 mL of distilled water R.<\/p>\n
Sulfates (2.4.13)<\/h3>\n
Maximum 100 ppm, determined on solution S.<\/p>\n
Loss on drying (2.2.32)<\/h4>\n
Maximum 0.5 per cent, determined on 1.000 g by drying in vacuo at 60 \u00b0C.<\/p>\n
Sulfated ash (2.4.14)<\/h4>\n
Maximum 0.1 per cent, determined on 1.0 g.<\/p>\n
ASSAY<\/h2>\n
Liquid chromatography (2.2.29) as described in the test for related substances with the following modifications.<\/p>\n
Injection 5 \u03bcL of the test solution and reference solution (a).<\/p>\n
System suitability Reference solution (a):<\/p>\n
\u2014 repeatability: maximum relative standard deviation of 1.0 per cent determined on 6 injections.<\/p>\n
STORAGE<\/h2>\n
Protected from light.<\/p>\n
IMPURITIES<\/h2>\n
Specified impurities A, B, G.<\/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) C, D, E, F.<\/p>\n
$\"Fenofibrate\"$ <\/p>\n
A. (4-chlorophenyl)(4-hydroxyphenyl)methanone,<\/p>\n
$\"Fenofibrate\"$ <\/p>\n
B. 2-[4-(4-chlorobenzoyl)phenoxy]-2-methylpropanoic acid (fenofibric acid),<\/p>\n
$\"Fenofibrate\"$ <\/p>\n
C. (3RS)-3-[4-(4-chlorobenzoyl)phenoxy]butan-2-one,<\/p>\n
$\"Fenofibrate\"$ <\/p>\n
D. methyl 2-[4-(4-chlorobenzoyl)phenoxy]-2-methylpropanoate,<\/p>\n
$\"Fenofibrate\"$ <\/p>\n
E. ethyl 2-[4-(4-chlorobenzoyl)phenoxy]-2-methylpropanoate,<\/p>\n
$\"Fenofibrate\"$ <\/p>\n
F. (4-chlorophenyl)[4-(1-methylethoxy)phenyl]methanone,<\/p>\n
$\"Fenofibrate\"$ <\/p>\n
G. 1-methylethyl 2-[[2-[4-(4-chlorobenzoyl)phenoxy]-2-methylpropanoyl]oxy]-2-methylpropanoate.<\/p>\n","protected":false},"excerpt":{"rendered":"
(Ph. Eur. monograph 1322) C20H21ClO4\u00a0 \u00a0 \u00a0 360.8\u00a0 \u00a0 \u00a0 49562-28-9 Action and use Fibrate; lipid-regulating drug. Preparations Fenofibrate Capsules Fenofibrate Tablets DEFINITION 1-Methylethyl 2-[4-(4-chlorobenzoyl)phenoxy]-2-methylpropanoate. Content 98.0 per cent to 102.0 per cent (dried substance). CHARACTERS Appearance White or almost white, crystalline powder. Solubility Practically insoluble in water, very soluble in methylene chloride, slightly soluble…<\/p>\n","protected":false},"author":2,"featured_media":1006,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[174],"tags":[],"class_list":["post-994","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\/994","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\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/comments?post=994"}],"version-history":[{"count":4,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/994\/revisions"}],"predecessor-version":[{"id":5148,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/994\/revisions\/5148"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/1006"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=994"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=994"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=994"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}

Content<\/h3>\n98.0 per cent to 102.0 per cent (dried substance).<\/p>\n

CHARACTERS<\/h2>\n

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

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

IDENTIFICATION<\/h2>\nA. Melting point (2.2.14): 79 \u00b0C to 82 \u00b0C.<\/p>\nB. Infrared absorption spectrophotometry (2.2.24).<\/p>\nComparison fenofibrate CRS.<\/p>\n

TESTS<\/h2>\n

Solution S<\/h3>\nTo 5.0 g, add 25 mL of distilled water R and heat at 50 \u00b0C for 10 min. Cool and dilute to 50.0 mL with distilled water R. Filter. Use the filtrate as solution S.<\/p>\n

Appearance of solution<\/h3>\nThe solution is clear (2.2.1) and not more intensely coloured than reference solution BY6 (2.2.2, Method II).<\/p>\nDissolve 0.50 g in acetone R and dilute to 10.0 mL with the same solvent.<\/p>\n

Acidity<\/h3>\nDissolve 1.0 g in 50 mL of ethanol (96 per cent) R previously neutralised using 0.2 mL of phenolphthalein solution R1. Not more than 0.2 mL of 0.1 M sodium hydroxide is required to change the colour of the indicator to pink.<\/p>\n

Halides expressed as chlorides (2.4.4)<\/h3>\nMaximum 100 ppm.<\/p>\nTo 5 mL of solution S add 10 mL of distilled water R.<\/p>\n

Sulfates (2.4.13)<\/h3>\nMaximum 100 ppm, determined on solution S.<\/p>\n

Loss on drying (2.2.32)<\/h4>\nMaximum 0.5 per cent, determined on 1.000 g by drying in vacuo at 60 \u00b0C.<\/p>\n

Sulfated ash (2.4.14)<\/h4>\nMaximum 0.1 per cent, determined on 1.0 g.<\/p>\n

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

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

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

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

IDENTIFICATION<\/h2>\n
A. Melting point (2.2.14): 79 \u00b0C to 82 \u00b0C.<\/p>\n
B. Infrared absorption spectrophotometry (2.2.24).<\/p>\n
Comparison fenofibrate CRS.<\/p>\n

Solution S<\/h3>\n
To 5.0 g, add 25 mL of distilled water R and heat at 50 \u00b0C for 10 min. Cool and dilute to 50.0 mL with distilled water R. Filter. Use the filtrate as solution S.<\/p>\n

Appearance of solution<\/h3>\n
The solution is clear (2.2.1) and not more intensely coloured than reference solution BY6 (2.2.2, Method II).<\/p>\n
Dissolve 0.50 g in acetone R and dilute to 10.0 mL with the same solvent.<\/p>\n

Acidity<\/h3>\n
Dissolve 1.0 g in 50 mL of ethanol (96 per cent) R previously neutralised using 0.2 mL of phenolphthalein solution R1. Not more than 0.2 mL of 0.1 M sodium hydroxide is required to change the colour of the indicator to pink.<\/p>\n

Halides expressed as chlorides (2.4.4)<\/h3>\n
Maximum 100 ppm.<\/p>\n
To 5 mL of solution S add 10 mL of distilled water R.<\/p>\n

Sulfates (2.4.13)<\/h3>\n
Maximum 100 ppm, determined on solution S.<\/p>\n

Loss on drying (2.2.32)<\/h4>\n
Maximum 0.5 per cent, determined on 1.000 g by drying in vacuo at 60 \u00b0C.<\/p>\n

Sulfated ash (2.4.14)<\/h4>\n
Maximum 0.1 per cent, determined on 1.0 g.<\/p>\n

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