Action and use<\/strong><\/p>\n Releases dopamine; central nervous system stimulant.<\/p>\n Bis[(2RS)-1-phenylpropan-2-amine] sulfate.<\/p>\n 99.0 per cent to 101.0 per cent (dried substance).<\/p>\n White or almost white powder.<\/p>\n Freely soluble in water, very slightly soluble in ethanol (96 per cent), practically insoluble in methylene chloride.<\/p>\n First identification: A, B, D.<\/p>\n Second identification: C, D.<\/p>\n A. Optical rotation (see Tests).<\/p>\n B. Infrared absorption spectrophotometry (2.2.24).<\/p>\n Comparison: amfetamine sulfate CRS.<\/p>\n C. To 50 mL of solution S add 5 mL of strong sodium hydroxide solution R and 0.5 mL of benzoyl chloride R and shake. Continue to add benzoyl chloride R in portions of 0.5 mL, shaking after each addition, until no further precipitate is formed. Filter, wash the precipitate with water R, recrystallise twice from a mixture of equal volumes of ethanol (96 per cent) R and water R, then dry at 100-105 \u00b0C. The crystals melt (2.2.14) at 131 \u00b0C to 135 \u00b0C.<\/p>\n D. Solution S (see Tests) gives reaction (a) of sulfates (2.3.1).<\/p>\n Dissolve 2.0 g in carbon dioxide-free water R and dilute to 100 mL with the same solvent.<\/p>\n Solution S is clear (2.2.1) and colourless (2.2.2, Method II).<\/p>\n -0.04\u00b0 to + 0.04\u00b0 (measured in a 2 dm tube), determined on solution S.<\/p>\n To 25 mL of solution S add 0.1 mL of methyl red solution R. Not more than 0.1 mL of 0.01 M hydrochloric acid or 0.01 M sodium hydroxide is required to change the colour of the indicator.<\/p>\n Liquid chromatography (2.2.29). Prepare the solutions immediately before use.<\/p>\n Solvent mixture: Mix 5 mL of trifluoroacetic acid R and 900 mL of water for chromatography R, adjust to pH 2.2 with concentrated ammonia R and dilute to 1000 mL with acetonitrile R. Reference solution (a): Dilute 1.0 mL of the test solution to 100.0 mL with the solvent mixture. Dilute 1.0 mL of this solution to 10.0 mL with the solvent mixture.<\/p>\n Reference solution (b): Dissolve 5 mg of 1-phenylpropan-2-ol R (impurity A) and 5 mg of benzaldehyde R (impurity D) in the solvent mixture and dilute to 10 mL with the solvent mixture. Dilute 1 mL of the solution to 100 mL with the solvent mixture.<\/p>\n Column:<\/p>\n \u2014 size: l = 0.15 m, \u00d8 = 4.6 mm;<\/p>\n \u2014 stationary phase: base-deactivated end-capped octadecylsilyl silica gel for chromatography R (5 \u03bcm);<\/p>\n \u2014 temperature: 40 \u00b0C.<\/p>\n Mobile phase:<\/p>\n \u2014 mobile phase A: solvent mixture;<\/p>\n \u2014 mobile phase B: acetonitrile R;<\/p>\n Flow rate: 1.5 mL\/min.<\/p>\n Detection: Spectrophotometer at 257 nm.<\/p>\n Injection: 20 \u03bcL.<\/p>\n Identification of impurities: Use the chromatogram obtained with reference solution (b) to identify the peaks due to impurities A and D.<\/p>\n Relative retention: With reference to amfetamine (retention time = about 8 min): impurity D = about 1.6; System suitability: Reference solution (b):<\/p>\n \u2014 resolution: minimum 4.0 between the peaks due to impurities D and A.<\/p>\n Calculation of percentage contents:<\/p>\n \u2014 for each impurity, use the concentration of amfetamine sulfate in reference solution (a).<\/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.<\/p>\n Maximum 1.0 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 0.300 g in 30 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 36.85 mg of C18<\/sub>H28<\/sub>N2<\/sub>O4<\/sub>S.<\/p>\n Protected from light.<\/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. (2RS)-1-phenylpropan-2-ol,<\/p>\n B. 1-phenylpropan-2-one,<\/p>\n C. (2S)-2-amino-1-phenylpropan-1-one (cathinone),<\/p>\n D. benzaldehyde.<\/p>\n","protected":false},"excerpt":{"rendered":" (Ph. Eur. monograph 0368) C18H28N2O4S\u00a0 \u00a0 368.5\u00a0 \u00a0 60-13-9 Action and use Releases dopamine; central nervous system stimulant. DEFINITION Bis[(2RS)-1-phenylpropan-2-amine] sulfate. Content 99.0 per cent to 101.0 per cent (dried substance). CHARACTERS Appearance White or almost white powder. Solubility Freely soluble in water, very slightly soluble in ethanol (96 per cent), practically insoluble in methylene…<\/p>\n","protected":false},"author":2,"featured_media":2079,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[174],"tags":[],"class_list":["post-2071","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\/2071","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=2071"}],"version-history":[{"count":4,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/2071\/revisions"}],"predecessor-version":[{"id":6989,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/2071\/revisions\/6989"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/2079"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=2071"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=2071"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=2071"}],"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
Solution S<\/h3>\n
Appearance of solution<\/h3>\n
Optical rotation (2.2.7)<\/h4>\n
Acidity or alkalinity<\/h3>\n
Related substances<\/h3>\n
\nTest solution Dissolve 20.0 mg of the substance to be examined in the solvent mixture and dilute to 10.0 mL with the solvent mixture.<\/p>\n\n\n
\n Time
\n(min)<\/td>\nMobile phase A
\n(per cent V\/V)<\/td>\nMobile phase B
\n(per cent V\/V)<\/td>\n<\/tr>\n\n 0 – 1<\/td>\n 100<\/td>\n 0<\/td>\n<\/tr>\n \n 1 – 16<\/td>\n 100 \u2192 65<\/td>\n 0 \u2192 35<\/td>\n<\/tr>\n \n 16 – 21<\/td>\n \u00a065 \u2192 0<\/td>\n 35 \u2192 100<\/td>\n<\/tr>\n \n 21 – 23<\/td>\n 0<\/td>\n 100<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n
\nimpurity A = about 1.7.<\/p>\nLoss on drying (2.2.32)<\/h4>\n
Sulfated ash (2.4.14)<\/h4>\n
ASSAY<\/h2>\n
STORAGE<\/h2>\n
IMPURITIES<\/h2>\n
![\"Amfetamine](\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/09\/Amfetamine-Sulfate-A-1-300x163.jpg\")
<\/p>\n![\"Amfetamine](\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/09\/Amfetamine-Sulfate-B-1-300x163.jpg\")
<\/p>\n![\"Amfetamine](\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/09\/Amfetamine-Sulfate-C-1-300x163.jpg\")
<\/p>\n![\"Amfetamine](\"https:\/\/nhathuocngocanh.com\/bp\/wp-content\/uploads\/2025\/09\/Amfetamine-Sulfate-D-1-300x163.jpg\")
<\/p>\n