Action and use<\/strong><\/p>\n Potassium channel opener.<\/p>\n Preparation<\/strong><\/p>\n Nicorandil Tablets<\/p>\n 2-[(Pyridin-3-ylcarbonyl)amino]ethyl nitrate.<\/p>\n 99.0 per cent to 101.0 per cent (anhydrous substance).<\/p>\n White or almost white, crystalline powder.<\/p>\n Sparingly soluble in water, freely soluble in anhydrous ethanol, practically insoluble in heptane.<\/p>\n Infrared absorption spectrophotometry (2.2.24).<\/p>\n Comparison: nicorandil CRS.<\/p>\n 5.5 to 7.0.<\/p>\n Dissolve: 0.25 g in carbon dioxide-free water R and dilute to 25 mL with the same solvent.<\/p>\n Liquid chromatography (2.2.29). Prepare the solutions immediately before use.<\/p>\n Test solution: Dissolve 50 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): Dissolve 2 mg of nicorandil impurity A CRS in the mobile phase using sonication and dilute to 25.0 mL with the mobile phase. Dilute 1.0 mL of the solution to 20.0 mL with the test solution.<\/p>\n Reference solution (b): 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 Column:<\/p>\n \u2014 size: l = 0.25 m, \u00d8 = 4.6 mm;<\/p>\n \u2014 stationary phase: end-capped octadecylsilyl silica gel for chromatography compatible with 100 per cent aqueous mobile phases R (5 \u03bcm).<\/p>\n Mobile phase: trifluoroacetic acid R, triethylamine R, tetrahydrofuran R, water R (3:5:10:982 V\/V\/V\/V).<\/p>\n Flow rate: 1.0 mL\/min.<\/p>\n Detection: Spectrophotometer at 254 nm.<\/p>\n Injection: 10 \u03bcL.<\/p>\n Run time: 1.5 times the retention time of nicorandil.<\/p>\n Identification of impurities: Use the chromatogram obtained with reference solution (a) to identify the peak due to impurity A.<\/p>\n Relative retention: With reference to nicorandil (retention time = about 19 min): impurity A = about 0.9.<\/p>\n System suitability: Reference solution (a):<\/p>\n \u2014 resolution: minimum 2.5 between the peaks due to impurity A and nicorandil.<\/p>\n Calculation of percentage contents:<\/p>\n \u2014 for each impurity, use the concentration of nicorandil in reference solution (b).<\/p>\n Limits:<\/p>\n \u2014 unspecified impurities: for each impurity, maximum 0.10 per cent;<\/p>\n \u2014 total: maximum 0.2 per cent;<\/p>\n \u2014 reporting threshold: 0.05 per cent.<\/p>\n Maximum 100 ppm.<\/p>\n Dissolve 5.000 g in 30 mL of ethanol (50 per cent V\/V) R, add 1 mL of dilute hydrochloric acid R and dilute to 50.0 mL with distilled water R.<\/p>\n Maximum 0.5 per cent.<\/p>\n Dissolve 0.300 g in a suitable solvent and dilute to 1.0 mL with the same solvent. Inject 0.400 mL of the solution through the septum.<\/p>\n Maximum 0.1 per cent, determined on 1.0 g.<\/p>\n Dissolve 0.150 g in 50 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 21.12 mg of C8<\/sub>H9<\/sub>N3<\/sub>O4<\/sub>.<\/p>\n At a temperature of 2 \u00b0C to 8 \u00b0C.<\/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) A, B, C, D.<\/p>\n A. 2-[(pyridin-4-ylcarbonyl)amino]ethyl nitrate,<\/p>\n B. N-(2-hydroxyethyl)pyridine-3-carboxamide,<\/p>\n C. 2-aminoethyl pyridine-3-carboxylate,<\/p>\n D. 3-(4,5-dihydro-1,3-oxazol-2-yl)pyridine.<\/p>\n","protected":false},"excerpt":{"rendered":" (Ph. Eur. monograph 2332) C8H9N3O4\u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 211.2\u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 65141-46-0 Action and use Potassium channel opener. Preparation Nicorandil Tablets DEFINITION 2-[(Pyridin-3-ylcarbonyl)amino]ethyl nitrate. Content 99.0 per cent to 101.0 per cent (anhydrous substance). CHARACTERS Appearance White or almost white, crystalline powder. Solubility Sparingly soluble in water,…<\/p>\n","protected":false},"author":2,"featured_media":25209,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[174],"tags":[],"class_list":["post-25193","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\/25193","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=25193"}],"version-history":[{"count":2,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/25193\/revisions"}],"predecessor-version":[{"id":25211,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/25193\/revisions\/25211"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/25209"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=25193"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=25193"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=25193"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}DEFINITION<\/h2>\n
Content<\/h3>\n
CHARACTERS<\/h2>\n
Appearance<\/h3>\n
Solubility<\/h3>\n
IDENTIFICATION<\/h2>\n
TESTS<\/h2>\n
pH (2.2.3)<\/h4>\n
Related substances<\/h3>\n
Sulfates (2.4.13)<\/h3>\n
Water (2.5.32)<\/h4>\n
Sulfated ash (2.4.14)<\/h4>\n
ASSAY<\/h2>\n
STORAGE<\/h2>\n
IMPURITIES<\/h2>\n
![\"Nicorandil\"](\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/Nicorandil-2-300x163.jpg\")
<\/p>\n![\"Nicorandil\"](\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/Nicorandil-3-300x163.jpg\")
<\/p>\n![\"Nicorandil\"](\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/Nicorandil-4-300x163.jpg\")
<\/p>\n![\"Nicorandil\"](\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/Nicorandil-5-300x163.jpg\")
<\/p>\n