{"id":26080,"date":"2025-11-05T10:55:18","date_gmt":"2025-11-05T03:55:18","guid":{"rendered":"https:\/\/nhathuocngocanh.com\/bp\/?p=26080"},"modified":"2025-11-06T09:32:38","modified_gmt":"2025-11-06T02:32:38","slug":"nevirapine","status":"publish","type":"post","link":"https:\/\/nhathuocngocanh.com\/bp\/nevirapine\/","title":{"rendered":"Nevirapine"},"content":{"rendered":"

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

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

Non-nucleoside reverse transcriptase inhibitor; antiviral (HIV).<\/p>\n

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

Nevirapine Tablets<\/p>\n

Nevirapine Prolonged-release Tablets<\/p>\n

\n

Ph Eur<\/p>\n

DEFINITION<\/h2>\n

11-Cyclopropyl-4-methyl-5,11-dihydro-6H-dipyrido [3,2-b:2\u2032,3\u2032-e][1,4]diazepin-6-one.<\/p>\n

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

97.5 per cent to 102.0 per cent (dried substance).<\/p>\n

CHARACTERS<\/h2>\n

Appearance<\/h3>\n

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

Solubility<\/h3>\n

Practically insoluble in water, sparingly soluble or slightly soluble in methylene chloride, slightly soluble in methanol.<\/p>\n

IDENTIFICATION<\/h2>\n

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

Comparison\u00a0 anhydrous nevirapine CRS.<\/p>\n

B. Loss on drying (see Tests).<\/p>\n

TESTS<\/h2>\n

Related substances<\/h3>\n

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

Test solution (a)\u00a0 Dissolve 24.0 mg of the substance to be examined in a mixture of 4 mL of acetonitrile R and 80 mL of the mobile phase and sonicate until dissolution is complete. Dilute to 100.0 mL with the mobile phase.<\/p>\n

Test solution (b)\u00a0 Dilute 3.0 mL of test solution (a) to 25.0 mL with the mobile phase.<\/p>\n

Reference solution (a)\u00a0 Dilute 1.0 mL of test solution (a) to 100.0 mL with the mobile phase. Dilute 5.0 mL of this solution to 50.0 mL with the mobile phase.<\/p>\n

Reference solution (b)\u00a0 Add 2.0 mL of the mobile phase to a vial of nevirapine for peak identification CRS
\n(containing impurities A, B and C), mix and sonicate for 1 min.<\/p>\n

Reference solution (c)\u00a0 Dissolve 24.0 mg of anhydrous nevirapine CRS in a mixture of 4 mL of acetonitrile R and 80 mL of the mobile phase and sonicate until complete dissolution. Dilute to 100.0 mL with the mobile phase. Dilute 3.0 mL of this solution to 25.0 mL with the mobile phase.<\/p>\n

Column:<\/p>\n

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

\u2014 stationary phase: end-capped amidohexadecylsilyl silica gel for chromatography R (5 \u00b5m);<\/p>\n

\u2014 temperature: 35 \u00b0C.<\/p>\n

Mobile phase\u00a0 Mix 20 volumes of acetonitrile R and 80 volumes of a 2.88 g\/L solution of ammonium dihydrogen phosphate R, previously adjusted to pH 5.0 using dilute sodium hydroxide solution R.<\/p>\n

Flow rate\u00a0 1.0 mL\/min.<\/p>\n

Detection\u00a0 Spectrophotometer at 220 nm.<\/p>\n

Injection\u00a0 50 \u00b5L of test solution (a) and reference solutions (a) and (b).<\/p>\n

Run time\u00a0 10 times the retention time of nevirapine.<\/p>\n

Identification of impurities\u00a0 Use the chromatogram supplied with nevirapine for peak identification CRS and the chromatogram obtained with reference solution (b) to identify the peaks due to impurities A, B and C.<\/p>\n

Relative retention\u00a0 With reference to nevirapine (retention time = about 8 min): impurity B = 0.7; impurity A = 1.5; impurity C = 2.8.<\/p>\n

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

\u2014 resolution: minimum 5 between the peaks due to impurity B and nevirapine.<\/p>\n

Limits:<\/p>\n

\u2014 impurities A, B, C: for each impurity, not more than twice the area of the principal peak in the chromatogram obtained with reference solution (a) (0.2 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 (a) (0.1 per cent);<\/p>\n

\u2014 total: not more than 6 times the area of the principal peak in the chromatogram obtained with reference solution (a) (0.6 per cent);<\/p>\n

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

Loss on drying (2.2.32)<\/strong><\/p>\n

Maximum 0.5 per cent, determined on 1.000 g by drying in an oven at 105 \u00b0C.<\/p>\n

Sulfated ash (2.4.14)<\/strong><\/p>\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 modification.<\/p>\n

Injection\u00a0 25 \u00b5L of test solution (b) and reference solution (c).<\/p>\n

Calculate the percentage content of C15<\/sub>H14<\/sub>N4<\/sub>O from the declared content of anhydrous nevirapine CRS.<\/p>\n

IMPURITIES<\/h2>\n

Specified impurities\u00a0 A, B, C.<\/p>\n

\"Nevirapine\"<\/p>\n

A. 11-ethyl-4-methyl-5,11-dihydro-6H-dipyrido[3,2-b:2\u2032,3\u2032-e][1,4]diazepin-6-one,<\/p>\n

\"Nevirapine\"<\/p>\n

B. 4-methyl-5,11-dihydro-6H-dipyrido[3,2-b:2\u2032,3\u2032-e][1,4]diazepin-6-one,<\/p>\n

\"Nevirapine\"<\/p>\n

C. 4-methyl-11-propyl-5,11-dihydro-6H-dipyrido[3,2-b:2\u2032,3\u2032-e][1,4]diazepin-6-one.<\/p>\n

\n

Ph Eur<\/p>\n","protected":false},"excerpt":{"rendered":"

Edition: BP 2025 (Ph. Eur. 11.6 update) Action and use Non-nucleoside reverse transcriptase inhibitor; antiviral (HIV). Preparations Nevirapine Tablets Nevirapine Prolonged-release Tablets Ph Eur DEFINITION 11-Cyclopropyl-4-methyl-5,11-dihydro-6H-dipyrido [3,2-b:2\u2032,3\u2032-e][1,4]diazepin-6-one. Content 97.5 per cent to 102.0 per cent (dried substance). CHARACTERS Appearance White or almost white powder. Solubility Practically insoluble in water, sparingly soluble or slightly soluble in…<\/p>\n","protected":false},"author":5,"featured_media":26088,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[174],"tags":[],"class_list":["post-26080","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\/26080","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=26080"}],"version-history":[{"count":4,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/26080\/revisions"}],"predecessor-version":[{"id":26740,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/26080\/revisions\/26740"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/26088"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=26080"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=26080"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=26080"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}