{"id":16225,"date":"2025-10-20T09:15:13","date_gmt":"2025-10-20T02:15:13","guid":{"rendered":"https:\/\/nhathuocngocanh.com\/bp\/?p=16225"},"modified":"2025-10-20T09:15:13","modified_gmt":"2025-10-20T02:15:13","slug":"isoconazole-nitrate","status":"publish","type":"post","link":"https:\/\/nhathuocngocanh.com\/bp\/isoconazole-nitrate\/","title":{"rendered":"Isoconazole Nitrate"},"content":{"rendered":"

C18<\/sub>H15<\/sub>Cl4<\/sub>N3<\/sub>O4<\/sub>\u00a0 \u00a0 \u00a0 479.1\u00a0 \u00a0 \u00a0 \u00a024168-96-5<\/p>\n

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

Antifungal.<\/p>\n

DEFINITION<\/h2>\n

1-[(2RS)-2-(2,4-Dichlorophenyl)-2-[(2,6-dichlorophenyl)methoxy]ethyl]-1H-imidazole nitrate.<\/p>\n

Content<\/h3>\n

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

CHARACTERS<\/h2>\n

Appearance<\/h3>\n

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

Solubility<\/h3>\n

Very slightly soluble in water, soluble in methanol, slightly soluble in ethanol (96 per cent).<\/p>\n

IDENTIFICATION<\/h2>\n

A. Melting point (2.2.14): 178 \u00b0C to 182 \u00b0C.<\/p>\n

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

Comparison: isoconazole nitrate CRS.<\/p>\n

TESTS<\/h2>\n

Solution S<\/h3>\n

Dissolve 0.20 g in methanol R and dilute to 20.0 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 Y7<\/sub> (2.2.2, Method II).<\/p>\n

Optical rotation (2.2.7)<\/h4>\n

-0.10\u00b0 to + 0.10\u00b0, determined on solution S.<\/p>\n

Related substances<\/h3>\n

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

Test solution: Dissolve 0.100 g of the substance to be examined in the mobile phase and dilute to 10.0 mL with the mobile phase.<\/p>\n

Reference solution (a): Dissolve 2.5 mg of isoconazole nitrate CRS and 2.5 mg of miconazole nitrate CRS (impurity C) in the mobile phase, then dilute to 100 mL with the mobile phase.<\/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 = 0.10 m, \u00d8 = 4.6 mm;<\/p>\n

\u2014 stationary phase: end-capped octadecylsilyl silica gel for chromatography R (3 \u03bcm).<\/p>\n

Mobile phase: Dissolve 6.0 g of ammonium acetate R in a mixture of 300 mL of acetonitrile for chromatography R, 320 mL of methanol R1 and 380 mL of water for chromatography R.<\/p>\n

Flow rate: 2 mL\/min.<\/p>\n

Detection: Spectrophotometer at 235 nm.<\/p>\n

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

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

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

Relative retention: With reference to isoconazole (retention time = about 14 min): nitrate = about 0.04; impurity C = about 1.4.<\/p>\n

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

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

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

\u2014 for each impurity, use the concentration of isoconazole nitrate 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 0.5 per cent;<\/p>\n

\u2014 reporting threshold: 0.05 per cent; disregard the peak due to the nitrate ion.<\/p>\n

Loss on drying (2.2.32)<\/h4>\n

Maximum 0.5 per cent, determined on 1.000 g by drying in an oven at 105 \u00b0C for 2 h.<\/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 0.350 g in 75 mL of a mixture of 1 volume of anhydrous acetic acid R and 7 volumes of methyl ethyl ketone R.<\/p>\n

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 47.91 mg of C18<\/sub>H15<\/sub>Cl4<\/sub>N3<\/sub>O4<\/sub>.<\/p>\n

STORAGE<\/h2>\n

Protected from light.<\/p>\n

IMPURITIES<\/h2>\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
\nthe 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.<\/p>\n

\"Isoconazole<\/p>\n

A. (1RS)-1-(2,4-dichlorophenyl)-2-(1H-imidazol-1-yl)ethan-1-ol,<\/p>\n

\"Isoconazole<\/p>\n

B. (2RS)-2-(2,4-dichlorophenyl)-2-[(2,6-dichlorophenyl)methoxy]ethan-1-amine,<\/p>\n

\"Isoconazole<\/p>\n

C. 1-[(2RS)-2-(2,4-dichlorophenyl)-2-[(2,4-dichlorophenyl)methoxy]ethyl]-1H-imidazole (miconazole).<\/p>\n","protected":false},"excerpt":{"rendered":"

C18H15Cl4N3O4\u00a0 \u00a0 \u00a0 479.1\u00a0 \u00a0 \u00a0 \u00a024168-96-5 Action and use Antifungal. DEFINITION 1-[(2RS)-2-(2,4-Dichlorophenyl)-2-[(2,6-dichlorophenyl)methoxy]ethyl]-1H-imidazole nitrate. Content 99.0 per cent to 101.0 per cent (dried substance). CHARACTERS Appearance White or almost white powder. Solubility Very slightly soluble in water, soluble in methanol, slightly soluble in ethanol (96 per cent). IDENTIFICATION A. Melting point (2.2.14): 178 \u00b0C to…<\/p>\n","protected":false},"author":2,"featured_media":16229,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[174],"tags":[],"class_list":["post-16225","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\/16225","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=16225"}],"version-history":[{"count":2,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/16225\/revisions"}],"predecessor-version":[{"id":16232,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/16225\/revisions\/16232"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/16229"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=16225"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=16225"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=16225"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}