{"id":5281,"date":"2025-09-29T11:36:05","date_gmt":"2025-09-29T04:36:05","guid":{"rendered":"https:\/\/nhathuocngocanh.com\/bp\/?p=5281"},"modified":"2025-10-03T15:39:59","modified_gmt":"2025-10-03T08:39:59","slug":"ciprofibrate","status":"publish","type":"post","link":"https:\/\/nhathuocngocanh.com\/bp\/ciprofibrate\/","title":{"rendered":"Ciprofibrate"},"content":{"rendered":"

(Ph. Eur. monograph 2013)<\/p>\n

C13<\/sub>H14<\/sub>Cl2<\/sub>O3<\/sub> 289.2 52214-84-3<\/p>\n

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

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

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

Ciprofibrate Tablets<\/p>\n

DEFINITION<\/h2>\n

2-[4-[(1RS)-2,2-Dichlorocyclopropyl]phenoxy]-2-methylpropanoic acid.<\/p>\n

Content<\/p>\n

99.0 per cent to 101.0 per cent (anhydrous substance).<\/p>\n

CHARACTERS<\/p>\n

Appearance<\/p>\n

White or slightly yellow, crystalline powder.<\/p>\n

Solubility<\/p>\n

Practically insoluble in water, freely soluble in anhydrous ethanol, soluble in toluene.<\/p>\n

mp<\/p>\n

About 115 \u00b0C.<\/p>\n

IDENTIFICATION<\/p>\n

Infrared absorption spectrophotometry (2.2.24).<\/p>\n

Comparison ciprofibrate CRS.<\/p>\n

TESTS<\/p>\n

Appearance of solution<\/p>\n

The solution is clear (2.2.1) and not more intensely coloured than reference solution BY4 (2.2.2, Method II).<\/p>\n

Dissolve 1.0 g in anhydrous ethanol R and dilute to 10.0 mL with the same solvent.<\/p>\n

Related substances<\/p>\n

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

Solvent mixture acetonitrile R, water R (50:50 V\/V).<\/p>\n

Test solution Dissolve 0.125 g of the substance to be examined in the solvent mixture and dilute to 50.0 mL with the solvent mixture.<\/p>\n

Reference solution (a) Dilute 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 (b) Dissolve the contents of a vial of ciprofibrate for system suitability B CRS (containing impurities A, C and E) in 2 mL of the solvent mixture.<\/p>\n

Column:<\/p>\n

\u2014 size: l = 0.15 m, \u00d8 = 4.6 mm;<\/p>\n

\u2014 stationary phase: end-capped octylsilyl silica gel for chromatography R (5 \u03bcm).<\/p>\n

Mobile phase:<\/p>\n

\u2014 mobile phase A: 1.36 g\/L solution of potassium dihydrogen phosphate R adjusted to pH 2.2 with phosphoric acid R;<\/p>\n

\u2014 mobile phase B: acetonitrile for chromatography R;<\/p>\n\n\n\n\n\n
Time
\n(min)<\/td>\n		Mobile phase A
\n(per cent V\/V)<\/td>\n		Mobile phase B
\n(per cent V\/V)<\/td>\n<\/tr>\n
0 – 30<\/td>\n\u00a075 \u2192 30<\/td>\n\u00a025 \u2192 70<\/td>\n<\/tr>\n
30 – 40<\/td>\n30<\/td>\n70<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

Flow rate 1.5 mL\/min.<\/p>\n

Detection: Spectrophotometer at 230 nm.<\/p>\n

Injection 10 \u03bcL.<\/p>\n

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

Relative retention With reference to ciprofibrate (retention time = about 19 min): impurity A = about 0.7;
\nimpurity C = about 0.95; impurity E = about 1.5.<\/p>\n

System suitability Reference solution (b):<\/p>\n

\u2014 resolution: minimum 3.0 between the peaks due to impurity C and ciprofibrate.<\/p>\n

Calculation of percentage contents:<\/p>\n

\u2014 correction factor: multiply the peak area of impurity A by 2.3;<\/p>\n

\u2014 for each impurity, use the concentration of ciprofibrate in reference solution (a).<\/p>\n

Limits:<\/p>\n

\u2014 impurity E: maximum 0.5 per cent;<\/p>\n

\u2014 impurity A: maximum 0.10 per cent;<\/p>\n

\u2014 unspecified impurities: for each impurity, maximum 0.10 per cent;<\/p>\n

\u2014 total: maximum 0.7 per cent;<\/p>\n

\u2014 reporting threshold: 0.05 per cent.<\/p>\n

Chlorides (2.4.4)<\/h3>\n

Maximum 350 ppm.<\/p>\n

To 0.190 g add 20 mL of water R and sonicate for 8 min. Filter. 15 mL of the filtrate complies with the test.<\/p>\n

Water (2.5.12)<\/h4>\n

Maximum 0.5 per cent, determined on 1.000 g.<\/p>\n

Sulfated ash (2.4.14)<\/h4>\n

Maximum 0.1 per cent, determined on 1.0 g.<\/p>\n

ASSAY<\/h2>\n

Dissolve 0.250 g in a mixture of 20 mL of water R and 40 mL of anhydrous ethanol R. Titrate with 0.1 M sodium hydroxide, determining the end-point potentiometrically (2.2.20).<\/p>\n

1 mL of 0.1 M sodium hydroxide is equivalent to 28.92 mg of C13<\/sub>H14<\/sub>Cl2<\/sub>O3<\/sub>.<\/p>\n

STORAGE<\/h2>\n

In an airtight container, protected from light.<\/p>\n

IMPURITIES<\/h2>\n

Specified impurities A, 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, C, D.<\/p>\n

\"Ciprofibrate-1\"<\/p>\n

A. 2-[4-(ethenyl)phenoxy]-2-methylpropanoic acid,<\/p>\n

\"Ciprofibrate-2\"<\/p>\n

B. 4-[(1RS)-2,2-dichlorocyclopropyl]phenol,<\/p>\n

\"Ciprofibrate-3\"<\/p>\n

C. 2-[4-[(1RS)-2,2-dichlorocyclopropyl]phenoxy]-2-methylpropan-1-ol,<\/p>\n

\"Ciprofibrate-4\"<\/p>\n

D. methyl 2-[4-[(1RS)-2,2-dichlorocyclopropyl]phenoxy]-2-methylpropanoate,<\/p>\n

\"Ciprofibrate-5\"<\/p>\n

E. ethyl 2-[4-[(1RS)-2,2-dichlorocyclopropyl]phenoxy]-2-methylpropanoate.<\/p>\n","protected":false},"excerpt":{"rendered":"

(Ph. Eur. monograph 2013) C13H14Cl2O3 289.2 52214-84-3 Action and use Fibrate; lipid-regulating drug. Preparation Ciprofibrate Tablets DEFINITION 2-[4-[(1RS)-2,2-Dichlorocyclopropyl]phenoxy]-2-methylpropanoic acid. Content 99.0 per cent to 101.0 per cent (anhydrous substance). CHARACTERS Appearance White or slightly yellow, crystalline powder. Solubility Practically insoluble in water, freely soluble in anhydrous ethanol, soluble in toluene. mp About 115 \u00b0C. IDENTIFICATION…<\/p>\n","protected":false},"author":3,"featured_media":5330,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[174],"tags":[],"class_list":["post-5281","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\/5281","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\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/comments?post=5281"}],"version-history":[{"count":2,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/5281\/revisions"}],"predecessor-version":[{"id":5343,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/5281\/revisions\/5343"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/5330"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=5281"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=5281"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=5281"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}