(Sorbitol, Liquid, Partially Dehydrated, Ph. Eur. monograph 2048)<\/p>\n
Action and use<\/strong><\/p>\n Excipient.<\/p>\n Partially dehydrated liquid sorbitol is obtained by acid-catalysed partial internal dehydration of liquid sorbitol. It contains not less than 68.0 per cent m\/m and not more than 85.0 per cent m\/m of anhydrous substances, composed of a mixture of mainly D-sorbitol and 1,4-sorbitan, with mannitol, hydrogenated oligo- and disaccharides, and sorbitans.<\/p>\n (nominal value):<\/p>\n \u2014 1,4-sorbitan (C6<\/sub>H12<\/sub>O5<\/sub>): minimum 15.0 per cent (anhydrous substance);<\/p>\n \u2014 D-sorbitol (C6<\/sub>H14<\/sub>O6<\/sub>): minimum 25.0 per cent (anhydrous substance).<\/p>\n The contents of 1,4-sorbitan and D-sorbitol are within 95.0 per cent to 105.0 per cent of the nominal values.<\/p>\n Clear, colourless, syrupy liquid.<\/p>\n Miscible with water, practically insoluble in mineral oils and vegetable oils.<\/p>\n Examine the chromatograms obtained in the assay.<\/p>\n Results The 2 principal peaks in the chromatogram obtained with the test solution are similar in retention time and size to the peaks in the chromatogram obtained with reference solution (a).<\/p>\n Dilute the substance to be examined with carbon dioxide-free water R prepared from distilled water R to obtain a solution containing 50.0 per cent m\/m of anhydrous substance.<\/p>\n Solution S is clear (2.2.1) and colourless (2.2.2, Method II).<\/p>\n Maximum 20 \u03bcS\u00b7cm-1<\/sup>. To an amount of the substance to be examined equivalent to 3.3 g of anhydrous substance, add 3 mL of water R, 20.0 mL of cupri-citric solution R and a few glass beads. Heat so that boiling begins after 4 min. Maintain boiling for 3 min. Cool rapidly and add 100 mL of a 2.4 per cent V\/V solution of glacial acetic acid R and 20.0 mL of 0.025 M iodine. With continuous shaking, add 25 mL of a mixture of 6 mL of hydrochloric acid R and 94 mL of water R. When the precipitate has dissolved, titrate the excess of iodine with 0.05 M sodium thiosulfate using 2 mL of starch solution R, added towards the end of the titration, as indicator. Not less than 12.8 mL of 0.05 M sodium thiosulfate is required.<\/p>\n 15.0 per cent to 32.0 per cent, determined on 0.100 g.<\/p>\n TAMC: acceptance criterion 103<\/sup> CFU\/g (2.6.12).<\/p>\n TYMC: acceptance criterion 102<\/sup> CFU\/g (2.6.12).<\/p>\n Absence of Escherichia coli (2.6.13).<\/p>\n Absence of Salmonella (2.6.13).<\/p>\n Liquid chromatography (2.2.29).Test solution Dissolve 0.400 g of the substance to\u00a0 be examined in water R and dilute to 20.0 mL with the same solvent.<\/p>\n Reference solution (a) Dissolve 50.0 mg of sorbitol CRS and 20.0 mg of 1,4-sorbitan CRS in water R and dilute to 5.0 mL with the same solvent.<\/p>\n Reference solution (b) Dissolve 0.100 g of mannitol R and 0.100 g of sorbitol R in water R and dilute to 10 mL with the same solvent.<\/p>\n Column: \u2014 stationary phase: strong cation-exchange resin (calcium form) R (9 \u03bcm);<\/p>\n \u2014 temperature: 55 \u00b1 5 \u00b0C.<\/p>\n Mobile phase: Degassed water for chromatography R.<\/p>\n Flow rate: 0.5 mL\/min.<\/p>\n Detection: Differential refractometer maintained at a constant temperature (e.g. 30-35 \u00b0C).<\/p>\n Injection: 20 \u03bcL.<\/p>\n Relative retention: With reference to D-sorbitol (retention time = about 30 min): 1,4-sorbitan = about 0.5; mannitol = about 0.8.<\/p>\n System suitability: Reference solution (b):<\/p>\n \u2014 resolution: minimum 2.0 between the peaks due to mannitol and D-sorbitol.<\/p>\n Calculate the percentage contents of 1,4-sorbitan (C6<\/sub>H12<\/sub>O5<\/sub>) and D-sorbitol (C6<\/sub>H14<\/sub>O6<\/sub>) taking into account the assigned contents of 1,4-sorbitan CRS and sorbitol CRS.<\/p>\n The label states the content of D-sorbitol and the content of 1,4-sorbitan (= nominal values).<\/p>\n","protected":false},"excerpt":{"rendered":" (Sorbitol, Liquid, Partially Dehydrated, Ph. Eur. monograph 2048) Action and use Excipient. DEFINITION Partially dehydrated liquid sorbitol is obtained by acid-catalysed partial internal dehydration of liquid sorbitol. It contains not less than 68.0 per cent m\/m and not more than 85.0 per cent m\/m of anhydrous substances, composed of a mixture of mainly D-sorbitol and…<\/p>\n","protected":false},"author":4,"featured_media":26158,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[174],"tags":[],"class_list":["post-26144","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\/26144","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\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/comments?post=26144"}],"version-history":[{"count":2,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/26144\/revisions"}],"predecessor-version":[{"id":26160,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/26144\/revisions\/26160"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/26158"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=26144"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=26144"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=26144"}],"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
Conductivity (2.2.38)<\/h3>\n
\nMeasure the conductivity of solution S, while gently stirring with a magnetic stirrer.
\nReducing sugars Maximum 0.3 per cent, calculated as glucose (anhydrous substance).<\/p>\nWater (2.5.12)<\/h3>\n
Microbial contamination<\/h3>\n
ASSAY<\/h2>\n
\n\u2014 size: l = 0.3 m, \u00d8 = 7.8 mm;<\/p>\nLABELLING<\/h2>\n