{"id":26406,"date":"2025-11-05T16:31:36","date_gmt":"2025-11-05T09:31:36","guid":{"rendered":"https:\/\/nhathuocngocanh.com\/bp\/?p=26406"},"modified":"2025-11-05T16:31:36","modified_gmt":"2025-11-05T09:31:36","slug":"pentoxyverine-citrate","status":"publish","type":"post","link":"https:\/\/nhathuocngocanh.com\/bp\/pentoxyverine-citrate\/","title":{"rendered":"Pentoxyverine Citrate"},"content":{"rendered":"

(Pentoxyverine Hydrogen Citrate, Ph. Eur. monograph 1621)<\/em><\/p>\n

C26<\/sub>H39<\/sub>NO10<\/sub> 525.6 23142-01-0<\/p>\n

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

Cough suppressant.<\/p>\n

DEFINITION<\/h2>\n

2-[2-(Diethylamino)ethoxy]ethyl 1-phenylcyclopentanecarboxylate dihydrogen 2-hydroxypropane-1,2,3-tricarboxylate.<\/p>\n

Content<\/h3>\n

98.5 per cent to 101.0 per cent (dried substance).<\/p>\n

CHARACTERS<\/h2>\n

Appearance<\/h3>\n

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

Solubility<\/h3>\n

Freely soluble in water, very soluble in glacial acetic acid, freely soluble in methanol, soluble in ethanol (96 per cent) and in methylene chloride.<\/p>\n

mp<\/h3>\n

About 93 \u00b0C.<\/p>\n

IDENTIFICATION<\/h2>\n

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

Comparison: Ph. Eur. reference spectrum of pentoxyverine hydrogen citrate.<\/p>\n

B. Dissolve 0.25 g in 5 mL of water R. The solution gives the reaction of citrates (2.3.1).<\/p>\n

TESTS<\/h2>\n

Solution S<\/h3>\n

Dissolve 5.0 g in carbon dioxide-free water R and dilute to 50 mL with the same solvent.<\/p>\n

Appearance of solution<\/h3>\n

Solution S is clear (2.2.1) and not more intensely coloured than reference solution Y6 (2.2.2, Method II).<\/p>\n

pH (2.2.3)<\/h3>\n

3.3 to 3.7 for solution S.<\/p>\n

Related substances<\/h3>\n

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

Test solution: Dissolve 25.0 mg of the substance to be examined in the mobile phase and dilute to 25.0 mL with the mobile phase.<\/p>\n

Reference solution: Introduce 5.0 mg of pentoxyverine impurity A CRS and 5.0 mg of pentoxyverine impurity B CRS in a conical flask, add 5.0 mL of the test solution and dilute to 100.0 mL with the mobile phase.<\/p>\n

Dilute 3.0 mL of the solution to 50.0 mL with the mobile phase.<\/p>\n

Column:<\/p>\n

\u2014 size: l = 0.15 m, \u00d8 = 3.9 mm,<\/p>\n

\u2014 stationary phase: end-capped octylsilyl silica gel for chromatography R (5 \u03bcm) with a pore size of 10 nm and a carbon loading of 12 per cent,<\/p>\n

\u2014 temperature: 50 \u00b0C.<\/p>\n

Mobile phase: Mix 35 volumes of acetonitrile R and 65 volumes of a 1.5 g\/L solution of sodium heptanesulfonate R adjusted to pH 3.0 with dilute sulfuric acid R.<\/p>\n

Flow rate: 1.0 mL\/min.<\/p>\n

Detection: Spectrophotometer at 205 nm.<\/p>\n

Injection: 20 \u03bcL.<\/p>\n

Run time: 3 times the retention time of pentoxyverine.<\/p>\n

Relative retention: With reference to pentoxyverine (retention time = about 6 min): impurity B = about 0.8; impurity A = about 1.5.<\/p>\n

System suitability: Reference solution:<\/p>\n

\u2014 resolution: minimum of 5.0 between the peaks due to pentoxyverine and to impurity A,<\/p>\n

\u2014 signal-to-noise ratio: minimum of 100 for the peak due to pentoxyverine,<\/p>\n

\u2014 symmetry factor: maximum of 2.0 for the peak due to pentoxyverine.<\/p>\n

Limits:<\/p>\n

\u2014 impurity A: not more than the area of the corresponding peak in the chromatogram obtained with the reference solution (0.3 per cent),<\/p>\n

\u2014 impurity B: not more than the area of the corresponding peak in the chromatogram obtained with the reference solution (0.3 per cent),<\/p>\n

\u2014 any other impurity: not more than one-third of the area of the peak due to pentoxyverine in the chromatogram obtained with the reference solution (0.1 per cent),<\/p>\n

\u2014 total of any other impurity: not more than the area of the peak due to pentoxyverine in the chromatogram obtained with the reference solution (0.3 per cent),<\/p>\n

\u2014 disregard limit: 0.1 times the area of the peak due to pentoxyverine in the chromatogram obtained with the reference solution (0.03 per cent); disregard any peak with a retention time less than or equal to 2.5 min.<\/p>\n

Loss on drying (2.2.32)<\/h3>\n

Maximum 0.5 per cent, determined on 1.000 g by drying in vacuo at 60 \u00b0C for 4 h.<\/p>\n

Sulfated ash (2.4.14)<\/h3>\n

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

ASSAY<\/h2>\n

Dissolve 0.400 g in 70 mL of anhydrous acetic acid R. Titrate with 0.1 M perchloric acid, determining the end-point potentiometrically (2.2.20).<\/p>\n

1 mL of 0.1 M perchloric acid is equivalent to 52.56 mg of C26<\/sub>H39<\/sub>NO10<\/sub>.<\/p>\n

STORAGE<\/h2>\n

Protected from light.<\/p>\n

IMPURITIES<\/h2>\n

\"Pentoxyverine<\/p>\n

A. 1-phenylcyclopentanecarboxylic acid,<\/p>\n

\"Pentoxyverine<\/p>\n

B. 2-(diethylamino)ethyl 1-phenylcyclopentanecarboxylate (caramiphen).<\/p>\n","protected":false},"excerpt":{"rendered":"

(Pentoxyverine Hydrogen Citrate, Ph. Eur. monograph 1621) C26H39NO10 525.6 23142-01-0 Action and use Cough suppressant. DEFINITION 2-[2-(Diethylamino)ethoxy]ethyl 1-phenylcyclopentanecarboxylate dihydrogen 2-hydroxypropane-1,2,3-tricarboxylate. Content 98.5 per cent to 101.0 per cent (dried substance). CHARACTERS Appearance White or almost white, crystalline powder. Solubility Freely soluble in water, very soluble in glacial acetic acid, freely soluble in methanol, soluble in…<\/p>\n","protected":false},"author":4,"featured_media":26418,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[174],"tags":[],"class_list":["post-26406","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\/26406","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=26406"}],"version-history":[{"count":2,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/26406\/revisions"}],"predecessor-version":[{"id":26423,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/26406\/revisions\/26423"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/26418"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=26406"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=26406"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=26406"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}