Edition: BP 2025 (Ph. Eur. 11.6 update)<\/p>\n
Action and use<\/strong><\/p>\n Angiotensis II (AT1) receptor antagonist.<\/p>\n Preparations <\/strong><\/p>\n Valsartan Capsules<\/p>\n Valsartan Tablets<\/p>\n (2S)-3-Methyl-2-[pentanoyl[[2\u2032-(1H-tetrazol-5-yl)biphenyl-4-yl]methyl]amino]butanoic acid.<\/p>\n Content<\/strong><\/p>\n 99.0 per cent to 101.0 per cent (anhydrous substance).<\/p>\n White or almost white, hygroscopic powder.<\/p>\n Practically insoluble in water, freely soluble in anhydrous ethanol, sparingly soluble in methylene chloride.<\/p>\n Carry out either tests A, B or tests A, C.<\/p>\n A. Infrared absorption spectrophotometry (2.2.24).<\/p>\n Comparison\u00a0 valsartan CRS.<\/p>\n B. Enantiomeric purity (see Tests).<\/p>\n C. Specific optical rotation (2.2.7): -69.0 to -64.0 (anhydrous substance). Dissolve 0.200 g in methanol R and dilute to 20.0 mL with the same solvent.<\/p>\n Liquid chromatography (2.2.29).<\/p>\n Test solution Dissolve 50 mg of the substance to be examined in the mobile phase and dilute to 50.0 mL with the mobile phase.<\/p>\n Reference solution (a) Dissolve 5 mg of valsartan for peak identification CRS (containing impurity A) in the mobile phase and dilute to 5 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.<\/p>\n Column:<\/p>\n \u2014 size: l = 0.25 m, \u00d8 = 4.6 mm;<\/p>\n \u2014 stationary phase: cellulose derivative of silica gel for chiral separation R (5 \u00b5m).<\/p>\n Mobile phase trifluoroacetic acid R, 2-propanol R, hexane R (0.1:15:85 V\/V\/V). Flow rate 0.8 mL\/min.<\/p>\n Detection\u00a0 Spectrophotometer at 230 nm.<\/p>\n Injection\u00a0 10 \u00b5L.<\/p>\n Run time\u00a0 1.5 times the retention time of valsartan.<\/p>\n Identification of impurities Use the chromatogram supplied with valsartan for peak identification CRS and the chromatogram obtained with reference solution (a) to identify the peak due to impurity A.<\/p>\n Relative retention\u00a0 With reference to valsartan (retention time = about 13 min): impurity A = about 0.6.<\/p>\n System suitability\u00a0 Reference solution (a):<\/p>\n \u2014 resolution: minimum 2.0 between the peaks due to impurity A and valsartan.<\/p>\n Limit:<\/p>\n \u2014 impurity A: not more than the area of the principal peak in the chromatogram obtained with reference solution (b) (1.0 per cent).<\/p>\n Liquid chromatography (2.2.29).<\/p>\n Test solution Dissolve 50 mg of the substance to be examined in the mobile phase and dilute to 100.0 mL with the mobile phase.<\/p>\n Reference solution (a) 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 (b) Dissolve the contents of a vial of valsartan for system suitability CRS (containing impurity C) in 1 mL of the mobile phase.<\/p>\n Column:<\/p>\n \u2014 size: l = 0.125 m, \u00d8 = 3.0 mm;<\/p>\n \u2014 stationary phase: end-capped octadecylsilyl silica gel for chromatography R (5 \u00b5m).<\/p>\n Mobile phase glacial acetic acid R, acetonitrile R1, water for chromatography R (1:500:500 V\/V\/V). Flow rate 0.4 mL\/min.<\/p>\n Detection\u00a0 Spectrophotometer at 225 nm.<\/p>\n Injection\u00a0 10 \u00b5L.<\/p>\n Run time\u00a0 6 times the retention time of valsartan.<\/p>\n Identification of impurities Use the chromatogram supplied with valsartan for system suitability CRS and the chromatogram obtained with reference solution (b) to identify the peak due to impurity C.<\/p>\n Relative retention\u00a0 With reference to valsartan (retention time = about 5 min): impurity C = about 0.8.<\/p>\n System suitability\u00a0 Reference solution (b):<\/p>\n \u2014 resolution: minimum 3.0 between the peaks due to impurity C and valsartan.<\/p>\n Limits:<\/p>\n \u2014 impurity C: 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) (0.10 per cent);<\/p>\n \u2014 total: not more than 3 times the area of the principal peak in the chromatogram obtained with reference solution (a) (0.3 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 Water (2.5.12)<\/strong><\/p>\n Maximum 2.0 per cent, determined on 0.500 g.<\/p>\n Sulfated ash (2.4.14)<\/strong><\/p>\n Maximum 0.1 per cent, determined on 1.0 g.<\/p>\n Dissolve 0.170 g in 70 mL of 2-propanol R. Titrate with 0.1 M tetrabutylammonium hydroxide in 2-propanol, determining the endpoint potentiometrically (2.2.20). Perform all operations under nitrogen.<\/p>\n 1 mL of 0.1 M tetrabutylammonium hydroxide in 2-propanol is equivalent to 21.78 mg of C24<\/sub>H29<\/sub>N5<\/sub>O3<\/sub>.<\/p>\n In an airtight container.<\/p>\n Specified impurities\u00a0 A, C.<\/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. Control of impurities in substances for pharmaceutical use) B.<\/em><\/p>\n A. (2R)-3-methyl-2-[pentanoyl[[2\u2032-(1H-tetrazol-5-yl)biphenyl-4-yl]methyl]amino]butanoic acid,<\/p>\n B. benzyl (2S)-3-methyl-2-[pentanoyl[[2\u2032-(1H-tetrazol-5-yl)biphenyl-4-yl]methyl]amino]butanoate,<\/p>\n C. (2S)-2-[butanoyl[[2\u2032-(1H-tetrazol-5-yl)biphenyl-4-yl]methyl]amino]-3-methylbutanoic acid.<\/p>\n","protected":false},"excerpt":{"rendered":" Edition: BP 2025 (Ph. Eur. 11.6 update) Action and use Angiotensis II (AT1) receptor antagonist. Preparations Valsartan Capsules Valsartan Tablets DEFINITION (2S)-3-Methyl-2-[pentanoyl[[2\u2032-(1H-tetrazol-5-yl)biphenyl-4-yl]methyl]amino]butanoic acid. Content 99.0 per cent to 101.0 per cent (anhydrous substance). CHARACTERS Appearance White or almost white, hygroscopic powder. Solubility Practically insoluble in water, freely soluble in anhydrous ethanol, sparingly soluble in methylene…<\/p>\n","protected":false},"author":5,"featured_media":30986,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[174],"tags":[],"class_list":["post-30985","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\/30985","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=30985"}],"version-history":[{"count":2,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/30985\/revisions"}],"predecessor-version":[{"id":30992,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/30985\/revisions\/30992"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/30986"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=30985"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=30985"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=30985"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}DEFINITION<\/h2>\n
CHARACTERS<\/h2>\n
Appearance<\/h3>\n
Solubility<\/h3>\n
IDENTIFICATION<\/h2>\n
TESTS<\/h2>\n
Enantiomeric purity<\/h3>\n
Related substances<\/h3>\n
ASSAY<\/h2>\n
STORAGE<\/h2>\n
IMPURITIES<\/h2>\n