Adrenoceptor agonist.<\/p>\n
Preparations<\/strong><\/p>\n Pseudoephedrine Oral Solution<\/p>\n Pseudoephedrine Tablets<\/p>\n Ph Eur<\/p>\n (1S,2S)-2-(Methylamino)-1-phenylpropan-1-ol hydrochloride.<\/p>\n Content<\/p>\n 99.0 per cent to 101.0 per cent (dried substance).<\/p>\n White or almost white, crystalline powder or colourless crystals.<\/p>\n Freely soluble in water and in ethanol (96 per cent), sparingly soluble in methylene chloride.<\/p>\n About 184 \u00b0C.<\/p>\n First identification: A, B, D.<\/em><\/p>\n Second identification: A, C, D.<\/em><\/p>\n A. Specific optical rotation (see Tests).<\/p>\n B. Infrared absorption spectrophotometry (2.2.24).<\/p>\n Comparison\u00a0 pseudoephedrine hydrochloride CRS.<\/p>\n C. Thin-layer chromatography (2.2.27).<\/p>\n Test solution\u00a0 Dissolve 20 mg of the substance to be examined in methanol R and dilute to 10 mL with the same solvent.<\/p>\n Reference solution (a) Dissolve 20 mg of pseudoephedrine hydrochloride CRS in methanol R and dilute to 10 mL with the same solvent.<\/p>\n Reference solution (b) Dissolve 10 mg of ephedrine hydrochloride CRS in reference solution (a) and dilute to 5 mL with reference solution (a).<\/p>\n Plate\u00a0 TLC silica gel plate R.<\/p>\n Mobile phase methylene chloride R, concentrated ammonia R, 2-propanol R (5:15:80 V\/V\/V). Application 10 \u00b5L.<\/p>\n Development\u00a0 Over 2\/3 of the plate.<\/p>\n Drying\u00a0 In air.<\/p>\n Detection\u00a0 Spray with ninhydrin solution R and heat at 110 \u00b0C for 5 min.<\/p>\n System suitability\u00a0 Reference solution (b):<\/p>\n \u2014 the chromatogram shows 2 clearly separated spots.<\/p>\n Results The principal spot in the chromatogram obtained with the test solution is similar in position, colour and size to the principal spot in the chromatogram obtained with reference solution (a).<\/p>\n D. Solution S (see Tests) gives reaction (a) of chlorides (2.3.1).<\/p>\n Dissolve 1.25 g in carbon dioxide-free water R and dilute to 25.0 mL with the same solvent.<\/p>\n Solution S is clear (2.2.1) and colourless (2.2.2, Method II).<\/p>\n Dilute 2 mL of solution S to 10 mL with carbon dioxide-free water R. Add 0.1 mL of methyl red solution R and 0.1 mL of 0.01 M sodium hydroxide; the solution is yellow. Add 0.2 mL of 0.01 M hydrochloric acid; the solution is red.<\/p>\n Specific optical rotation (2.2.7)<\/strong><\/p>\n + 61.0 to + 62.5 (dried substance), determined on solution S.<\/p>\n Liquid chromatography (2.2.29).<\/p>\n Test solution Dissolve 50.0 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 20.0 mg of ephedrine hydrochloride CRS (impurity A) in the mobile phase and dilute to 20.0 mL with the mobile phase. Dilute 1.0 mL of this solution to 50.0 mL with the mobile phase.<\/p>\n Reference solution (b)\u00a0 Dilute 1.0 mL of the test solution to 200.0 mL with the mobile phase.<\/p>\n Reference solution (c) Dissolve 10 mg of ephedrine hydrochloride CRS (impurity A) in 5 mL of the test solution and dilute to 100 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: phenylsilyl silica gel for chromatography R (5 \u00b5m).<\/p>\n Mobile phase Mix 6 volumes of methanol R and 94 volumes of an 11.6 g\/L solution of ammonium acetate R previously adjusted to pH 4.0 with glacial acetic acid R.<\/p>\n Flow rate\u00a0 1 mL\/min.<\/p>\n Detection\u00a0 Spectrophotometer at 257 nm.<\/p>\n Injection\u00a0 20 \u00b5L.<\/p>\n Run time\u00a0 1.5 times the retention time of pseudoephedrine.<\/p>\n Relative retention\u00a0 With reference to pseudoephedrine (retention time = about 18 min): impurity A = about 0.9.<\/p>\n System suitability\u00a0 Reference solution (c):<\/p>\n \u2014 resolution: minimum 2.0 between the peaks due to impurity A and pseudoephedrine; if necessary, reduce the content of methanol in the mobile phase.<\/p>\n Limits:<\/p>\n \u2014 impurity A: not more than the area of the principal peak in the chromatogram obtained with reference solution (a) (1.0 per cent);<\/p>\n \u2014 any other impurity: for each impurity, not more than the area of the principal peak in the chromatogram obtained with reference solution (b) (0.5 per cent);<\/p>\n \u2014 sum of impurities other than A: not more than twice the area of the principal peak in the chromatogram obtained with reference solution (b) (1.0 per cent);<\/p>\n \u2014 disregard limit: 0.1 times the area of the principal peak in the chromatogram obtained with reference solution (b) (0.05 per cent).<\/p>\n Maximum 0.5 per cent, determined on 1.000 g by drying in an oven at 105 \u00b0C.<\/p>\n Maximum 0.1 per cent, determined on 1.0 g.<\/p>\n Dissolve 0.170 g in 30 mL of ethanol (96 per cent) R. Add 5.0 mL of 0.01 M hydrochloric acid. Carry out a potentiometric titration (2.2.20), using 0.1 M sodium hydroxide. Read the volume added between the 2 points of inflexion.<\/p>\n 1 mL of 0.1 M sodium hydroxide is equivalent to 20.17 mg of C10<\/sub>H16<\/sub>ClNO.<\/p>\n Protected from light.<\/p>\n Specified impurities\u00a0 A.<\/p>\n A.\u00a0 (1R,2S)-2-(methylamino)-1-phenylpropan-1-ol (ephedrine).<\/p>\n Ph Eur<\/p>\n","protected":false},"excerpt":{"rendered":" Edition: BP 2025 (Ph. Eur. 11.6 update) Action and use Adrenoceptor agonist. Preparations Pseudoephedrine Oral Solution Pseudoephedrine Tablets Ph Eur DEFINITION (1S,2S)-2-(Methylamino)-1-phenylpropan-1-ol hydrochloride. Content 99.0 per cent to 101.0 per cent (dried substance). CHARACTERS Appearance White or almost white, crystalline powder or colourless crystals. Solubility Freely soluble in water and in ethanol (96 per cent),…<\/p>\n","protected":false},"author":5,"featured_media":28594,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[174],"tags":[],"class_list":["post-28592","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\/28592","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=28592"}],"version-history":[{"count":4,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/28592\/revisions"}],"predecessor-version":[{"id":31661,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/28592\/revisions\/31661"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/28594"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=28592"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=28592"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=28592"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}
\nDEFINITION<\/h2>\n
CHARACTERS<\/h2>\n
Appearance<\/h3>\n
Solubility<\/h3>\n
mp<\/h3>\n
IDENTIFICATION<\/h2>\n
TESTS<\/h2>\n
Solution S<\/h3>\n
Appearance of solution<\/h3>\n
Acidity or alkalinity<\/h3>\n
Related substances<\/h3>\n
Loss on drying (2.2.32)<\/h4>\n
Sulfated ash (2.4.14)<\/h4>\n
ASSAY<\/h2>\n
STORAGE<\/h2>\n
IMPURITIES<\/h2>\n
![\"Pseudoephedrine](\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/11\/Pseudoephedrine-Hydrochloride-British-Pharmacopoeia-2025-1.jpg\")
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