{"id":26548,"date":"2025-11-05T17:29:15","date_gmt":"2025-11-05T10:29:15","guid":{"rendered":"https:\/\/nhathuocngocanh.com\/bp\/?p=26548"},"modified":"2025-11-06T17:26:40","modified_gmt":"2025-11-06T10:26:40","slug":"omeprazole-sodium","status":"publish","type":"post","link":"https:\/\/nhathuocngocanh.com\/bp\/omeprazole-sodium\/","title":{"rendered":"Omeprazole Sodium"},"content":{"rendered":"

Edition: BP 2025 (Ph. Eur. 11.6 update)<\/p>\n

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

Proton pump inhibitor; treatment of peptic ulcer disease.<\/p>\n

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

Omeprazole for Injection<\/p>\n

Ph Eur<\/p>\n

\n

DEFINITION<\/h2>\n

Sodium 5-methoxy-2-[(RS)-[(4-methoxy-3,5-dimethylpyridin-2-yl)methyl]sulfinyl]-1H-benzimidazole monohydrate.<\/p>\n

Content<\/strong><\/p>\n

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

CHARACTERS<\/h2>\n

Appearance<\/h3>\n

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

Solubility<\/h3>\n

Freely soluble in water and in ethanol (96 per cent), soluble in propylene glycol, very slightly soluble in methylene chloride.<\/p>\n

IDENTIFICATION<\/h2>\n

A. Optical rotation (2.2.7): -0.10\u00b0 to + 0.10\u00b0, determined on solution S.<\/p>\n

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

Preparation\u00a0 Dissolve 0.50 g of the substance to be examined in 1.50 mL of water R, add 3.0 mL of
\nmethanol R and stir; while stirring, adjust to pH 8-9 by adding, dropwise, dilute acetic acid R (about 0.4 mL); continue stirring until crystallisation and isolate the crystalline precipitate by filtration; wash with 5 mL of water R, then 2 mL of methanol R, and dry in vacuo at 40 \u00b0C for 30 min.<\/p>\n

Comparison\u00a0 omeprazole CRS.<\/p>\n

If the spectra obtained in the solid state show differences, dissolve the crystalline precipitate and the reference substance separately in methanol R, evaporate to dryness and record new spectra using the residues.<\/p>\n

C. Ignite 1 g and cool. Add 1 mL of water R to the residue and neutralise with hydrochloric acid R. Filter and dilute the filtrate to 4 mL with water R. 0.1 mL of the solution gives reaction (b) of sodium (2.3.1).<\/p>\n

TESTS<\/h2>\n

Solution S<\/h3>\n

Dissolve 0.50 g in carbon dioxide-free water R and dilute to 25 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 B6 (2.2.2, Method II).<\/p>\n

pH (2.2.3)<\/strong><\/p>\n

10.3 to 11.3 for solution S.<\/p>\n

Related substances<\/h3>\n

Liquid chromatography (2.2.29). Prepare solutions immediately before use.<\/p>\n

Test solution\u00a0 Dissolve 3 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 (a)\u00a0 Dissolve 1 mg of omeprazole CRS and 1 mg of omeprazole impurity D CRS in the mobile phase and dilute to 10.0 mL with the mobile phase.<\/p>\n

Reference solution (b)\u00a0 Dilute 1.0 mL of the test solution to 100.0 mL with the mobile phase. Dilute 1.0 mL of this solution to 10.0 mL with the mobile phase.<\/p>\n

Reference solution (c)\u00a0 Dissolve 3 mg of omeprazole for peak identification CRS (containing impurity E) in the mobile phase and dilute to 25.0 mL with the mobile phase.<\/p>\n

Column:<\/p>\n

\u2014 size: l = 0.125 m, \u00d8 = 4.6 mm;<\/p>\n

\u2014 stationary phase: octylsilyl silica gel for chromatography R (5 \u00b5m).<\/p>\n

Mobile phase\u00a0 Mix 27 volumes of acetonitrile R and 73 volumes of a 1.4 g\/L solution of disodium hydrogen phosphate dodecahydrate R, previously adjusted to pH 7.6 with phosphoric acid R.<\/p>\n

Flow rate\u00a0 1 mL\/min.<\/p>\n

Detection\u00a0 Spectrophotometer at 280 nm.<\/p>\n

Injection\u00a0 40 \u00b5L.<\/p>\n

Run time\u00a0 5 times the retention time of omeprazole.<\/p>\n

Identification of impurities\u00a0 Use the chromatogram supplied with omeprazole for peak identification CRS and the chromatogram obtained with reference solution (c) to identify the peak due to impurity E; use the chromatogram obtained with reference solution (a) to identify the peak due to impurity D.<\/p>\n

Relative retention\u00a0 With reference to omeprazole (retention time = about 9 min): impurity E = about 0.6; impurity D = about 0.8.<\/p>\n

System suitability\u00a0 Reference solution (a):<\/p>\n

\u2014 resolution: minimum 3.0 between the peaks due to impurity D and omeprazole; if necessary adjust the pH of the aqueous part of the mobile phase or the concentration of acetonitrile R; an increase in the pH will improve the resolution.<\/p>\n

Limits:<\/p>\n

\u2014 impurities D, E: for each impurity, not more than 1.5 times the area of the principal peak in the chromatogram obtained with reference solution (b) (0.15 per cent);<\/p>\n

\u2014 unspecified impurities: for each impurity, not more than the area of the principal peak 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 principal peak in the chromatogram obtained with reference solution (b) (0.5 per cent);<\/p>\n

\u2014 disregard limit: 0.5 times the area of the principal peak in the chromatogram obtained with reference solution (b) (0.05 per cent).<\/p>\n

Water (2.5.12)<\/strong><\/p>\n

4.5 per cent to 10.0 per cent, determined on 0.300 g.<\/p>\n

ASSAY<\/h2>\n

Dissolve 0.300 g in 50 mL of water R. Titrate with 0.1 M hydrochloric acid, determining the end-point potentiometrically (2.2.20).<\/p>\n

1 mL of 0.1 M hydrochloric acid corresponds to 36.74 mg of C17H18N3NaO3S.<\/p>\n

STORAGE<\/h2>\n

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

IMPURITIES<\/h2>\n

Specified impurities\u00a0 D, E.<\/em><\/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.<\/em><\/p>\n

Control of impurities in substances for pharmaceutical use)\u00a0 A, B, C.<\/em><\/p>\n

\"Omeprazole<\/p>\n

A. 5-methoxy-1H-benzimidazole-2-thiol,<\/p>\n

\"Omeprazole<\/p>\n

B. 2-[(RS)-[(3,5-dimethylpyridin-2-yl)methyl]sulfinyl]-5-methoxy-1H-benzimidazole,<\/p>\n

\"Omeprazole<\/p>\n

C. 5-methoxy-2-[[(4-methoxy-3,5-dimethylpyridin-2-yl)methyl]sulfanyl]-1H-benzimidazole (ufiprazole),<\/p>\n

\"Omeprazole<\/p>\n

D. 5-methoxy-2-[[(4-methoxy-3,5-dimethylpyridin-2-yl)methyl]sulfonyl]-1H-benzimidazole (omeprazole- sulfone),<\/p>\n","protected":false},"excerpt":{"rendered":"

Edition: BP 2025 (Ph. Eur. 11.6 update) Action and use Proton pump inhibitor; treatment of peptic ulcer disease. Preparation Omeprazole for Injection Ph Eur DEFINITION Sodium 5-methoxy-2-[(RS)-[(4-methoxy-3,5-dimethylpyridin-2-yl)methyl]sulfinyl]-1H-benzimidazole monohydrate. Content 98.0 per cent to 101.0 per cent (anhydrous substance). CHARACTERS Appearance White or almost white, hygroscopic powder. Solubility Freely soluble in water and in ethanol (96…<\/p>\n","protected":false},"author":5,"featured_media":26549,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[174],"tags":[],"class_list":["post-26548","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\/26548","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\/5"}],"replies":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/comments?post=26548"}],"version-history":[{"count":3,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/26548\/revisions"}],"predecessor-version":[{"id":27326,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/26548\/revisions\/27326"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/26549"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=26548"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=26548"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=26548"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}