{"id":9017,"date":"2025-10-04T14:08:49","date_gmt":"2025-10-04T07:08:49","guid":{"rendered":"https:\/\/nhathuocngocanh.com\/bp\/?p=9017"},"modified":"2025-10-04T14:09:51","modified_gmt":"2025-10-04T07:09:51","slug":"deferiprone","status":"publish","type":"post","link":"https:\/\/nhathuocngocanh.com\/bp\/deferiprone\/","title":{"rendered":"Deferiprone"},"content":{"rendered":"

(Ph. Eur. monograph 2236)<\/p>\n

C7<\/sub>H9<\/sub>NO2<\/sub>\u00a0 \u00a0139.2\u00a0 \u00a030652-11-0<\/p>\n

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

Chelating agent (iron).<\/p>\n

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

Deferiprone Oral Solution<\/p>\n

Deferiprone Tablets<\/p>\n

DEFINITION<\/h2>\n

3-Hydroxy-1,2-dimethylpyridin-4-(1H)-one.<\/p>\n

Content<\/h3>\n

98.0 per cent to 102.0 per cent (anhydrous substance).<\/p>\n

CHARACTERS<\/h2>\n

Appearance<\/h3>\n

White or pinkish-white powder.<\/p>\n

Solubility<\/h3>\n

Sparingly soluble in water, slightly soluble in anhydrous ethanol, practically insoluble in heptane.<\/p>\n

IDENTIFICATION<\/h2>\n

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

Comparison deferiprone CRS.<\/p>\n

TESTS<\/h2>\n

Related substances<\/h3>\n

Liquid chromatography (2.2.29). Use only colourless glassware. Protect the solutions from light.<\/p>\n

Solution A: Dissolve 2.91 g of sodium edetate R, 4.01 g of sodium octanesulfonate monohydrate R and 6.20 g of
\ndipotassium hydrogen phosphate R in water for chromatography R and dilute to 2000 mL with the same solvent; adjust to pH 3.0 with phosphoric acid R.<\/p>\n

Solution B: Dissolve 0.73 g of sodium edetate R, 1.0 g of sodium octanesulfonate monohydrate R and 1.55 g of
\ndipotassium hydrogen phosphate R in water for chromatography R and dilute to 2000 mL with the same solvent; adjust to pH 3.0 with phosphoric acid R.<\/p>\n

Solvent mixture acetonitrile R, water R (10:90 V\/V).<\/p>\n

Test solution (a): Dissolve 0.100 g of the substance to be examined in a volume of the mobile phase corresponding to about 2\/3 of the final volume and dilute to 100.0 mL with the mobile phase.<\/p>\n

Test solution (b): Dissolve 50.0 mg of the substance to be examined in a volume of the solvent mixture corresponding to about 2\/3 of the final volume and dilute to 50.0 mL with the solvent mixture. Dilute 5.0 mL of the solution to 200.0 mL with the mobile phase described under Assay.<\/p>\n

Reference solution (a) Dissolve 2 mg of maltol R (impurity B) in the mobile phase and dilute to 100.0 mL with the mobile phase. To 2.5 mL of the solution add 10 mL of test solution (a) and dilute to 100.0 mL with the mobile phase.<\/p>\n

Reference solution (b) Dilute 1.0 mL of test solution (a) to 100.0 mL with the mobile phase. Dilute 1.0 mL of this solution to 20.0 mL with the mobile phase.<\/p>\n

Reference solution (c) Dissolve 50.0 mg of deferiprone CRS in a volume of the solvent mixture corresponding to
\nabout 2\/3 of the final volume and dilute to 50.0 mL with the solvent mixture. Dilute 5.0 mL of the solution to 200.0 mL with the mobile phase described under Assay.<\/p>\n

Column:<\/p>\n

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

\u2014 stationary phase: styrene-divinylbenzene copolymer R (5 \u03bcm);<\/p>\n

\u2014 temperature: 30 \u00b0C.<\/p>\n

Mobile phase acetonitrile R, solution A (10:90 V\/V).<\/p>\n

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

Detection: Spectrophotometer at 280 nm.<\/p>\n

Preconditioning of the column: Rinse for 20 min with the mobile phase before each series of injections.<\/p>\n

Injection 20 \u03bcL of test solution (a) and reference solutions (a) and (b).<\/p>\n

Run time 3.5 times the retention time of deferiprone.<\/p>\n

Identification of impurities: Use the chromatogram obtained with reference solution (a) to identify the peak due to
\nimpurity B.<\/p>\n

Relative retention: With reference to deferiprone (retention time = about 12 min): impurity B = about 0.5.<\/p>\n

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

\u2014 resolution: minimum 5.0 between the peaks due to impurity B and deferiprone.<\/p>\n

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

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

Limits:<\/p>\n

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

\u2014 unspecified impurities: for each impurity, maximum 0.05 per cent;<\/p>\n

\u2014 total: maximum 0.2 per cent;<\/p>\n

\u2014 reporting threshold: 0.03 per cent.<\/p>\n

Water (2.5.32)<\/h4>\n

Maximum 0.5 per cent, determined on 0.100 g by direct sample introduction.<\/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

Mobile phase acetonitrile R, solution B (10:90 V\/V).<\/p>\n

Injection 10 \u03bcL of test solution (b) and reference solution (c).<\/p>\n

Run time Twice the retention time of deferiprone.<\/p>\n

Retention time Deferiprone = about 7.7 min.<\/p>\n

Calculate the percentage content of C7<\/sub>H9<\/sub>NO2<\/sub> taking into account the assigned content of deferiprone CRS.<\/p>\n

IMPURITIES<\/h2>\n

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

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

A. 1-methyl-3-(methylamino)-1,5-dihydro-2H-pyrrol-2-one,<\/p>\n

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

B. 3-hydroxy-2-methyl-4H-pyran-4-one (maltol),<\/p>\n

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

C. 1,2-dimethyl-4-[(\u039e)-methylimino]-1,4-dihydropyridin-3-ol.<\/p>\n","protected":false},"excerpt":{"rendered":"

(Ph. Eur. monograph 2236) C7H9NO2\u00a0 \u00a0139.2\u00a0 \u00a030652-11-0 Action and use Chelating agent (iron). Preparations Deferiprone Oral Solution Deferiprone Tablets DEFINITION 3-Hydroxy-1,2-dimethylpyridin-4-(1H)-one. Content 98.0 per cent to 102.0 per cent (anhydrous substance). CHARACTERS Appearance White or pinkish-white powder. Solubility Sparingly soluble in water, slightly soluble in anhydrous ethanol, practically insoluble in heptane. IDENTIFICATION Infrared absorption spectrophotometry…<\/p>\n","protected":false},"author":3,"featured_media":9052,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[174],"tags":[],"class_list":["post-9017","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\/9017","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=9017"}],"version-history":[{"count":3,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/9017\/revisions"}],"predecessor-version":[{"id":9057,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/9017\/revisions\/9057"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/9052"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=9017"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=9017"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=9017"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}