{"id":16861,"date":"2025-10-21T13:43:34","date_gmt":"2025-10-21T06:43:34","guid":{"rendered":"https:\/\/nhathuocngocanh.com\/bp\/?p=16861"},"modified":"2025-11-15T16:08:06","modified_gmt":"2025-11-15T09:08:06","slug":"isomalt","status":"publish","type":"post","link":"https:\/\/nhathuocngocanh.com\/bp\/isomalt\/","title":{"rendered":"Isomalt"},"content":{"rendered":"

Isomalt1<\/sup><\/p>\n

(Ph. Eur. monograph 1531)<\/em><\/p>\n

C12<\/sub>H24<\/sub>O11<\/sub> 344.3<\/p>\n

C12<\/sub>H24<\/sub>O11<\/sub>,2H2<\/sub>O 380.3<\/p>\n

Anhydrous isomalt 64519-82-0<\/p>\n

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

Sweetening agent.<\/p>\n

DEFINITION<\/h2>\n

Mixture of 6-O-\u03b1-D-glucopyranosyl-D-glucitol (6-O-\u03b1-D-glucopyranosyl-D-sorbitol; 1,6-GPS) and 1-O-\u03b1-D-glucopyranosyl-D- mannitol (1,1-GPM).<\/p>\n

Content<\/h3>\n

98.0 per cent to 102.0 per cent for the mixture of 1,6-GPS and 1,1-GPM and neither of the 2 components is less than 3.0 per cent (anhydrous substance).<\/p>\n

CHARACTERS<\/h2>\n

Appearance<\/h3>\n

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

Solubility<\/h3>\n

Freely soluble in water, practically insoluble in anhydrous ethanol.\u2666<\/p>\n

IDENTIFICATION<\/h2>\n

First identification: A.<\/p>\n

Second identification: B, C.\u2662<\/p>\n

A. 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 to the 2 principal peaks in the chromatogram obtained with reference solution (a).<\/p>\n

B. Thin-layer chromatography (2.2.27).<\/p>\n

Test solution: Dissolve 50 mg of the substance to be examined in water R and dilute to 10 mL with the same solvent.<\/p>\n

Reference solution: Dissolve 50 mg of isomalt CRS in water R and dilute to 10 mL with the same solvent.<\/p>\n

Plate: TLC silica gel F254 plate R.<\/p>\n

Mobile phase: acetic acid R, propionic acid R, water R, ethyl acetate R, pyridine R (5:5:10:50:50 V\/V\/V\/V\/V).<\/p>\n

Application: 1 \u03bcL; thoroughly dry the points of application in warm air.<\/p>\n

Development: Over 1\/2 of the plate.<\/p>\n

Drying: In a current of warm air.<\/p>\n

Detection: Dip for 3 s in a 1 g\/L solution of sodium periodate R and dry in a current of hot air; dip for 3 s in a mixture of volume of acetic acid R, 1 volume of anisaldehyde R, 5 volumes of sulfuric acid R and 90 volumes of anhydrous ethanol R; dry in a current of hot air until coloured spots become visible; the background colour may be brightened in
\nwarm steam; examine in daylight.<\/p>\n

Results: The chromatogram obtained with the reference solution shows 2 blue-grey spots with RF values of about 0.13 (1,6-GPS) and 0.16 (1,1-GPM). The chromatogram obtained with the test solution shows principal spots similar in position and colour to the principal spots in the chromatogram obtained with the reference solution.<\/p>\n

C. To 3 mL of a freshly prepared 100 g\/L solution of pyrocatechol R add 6 mL of sulfuric acid R while cooling in iced water. To 3 mL of the cooled mixture add 0.3 mL of a 100 g\/L solution of the substance to be examined. Heat gently over a naked flame for about 30 s. A pink colour develops.\u2662<\/p>\n

TESTS<\/h2>\n

Conductivity (2.2.38)<\/h3>\n

Maximum 20 \u03bcS\u00b7cm .<\/p>\n

Dissolve 20.0 g in carbon dioxide-free water R with gentle heating (40-50 \u00b0C) and dilute to 100.0 mL with the same solvent. Measure the conductivity of the solution while gently stirring with a magnetic stirrer.<\/p>\n

Reducing sugars<\/h3>\n

Maximum 0.3 per cent, expressed as glucose equivalent.<\/p>\n

Dissolve 3.3 g in 10 mL of water R with gentle heating. Cool and add 20 mL of cupri-citric solution R and a few glass beads. Heat so that boiling begins after 4 min and 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 volumes of hydrochloric acid R and 94 volumes of water R. When the precipitate has dissolved, titrate the excess of iodine with 0.05 M sodium thiosulfate using 1 mL of starch solution R as indicator, added towards the end of the titration.<\/p>\n

Not less than 12.8 mL of 0.05 M sodium thiosulfate is required.<\/p>\n

Related substances<\/h3>\n

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

Test solution: Dissolve 0.200 g of the substance to be examined in 4 mL of water R and dilute to 10.0 mL with the same solvent.<\/p>\n

Reference solution (a): Dissolve 0.200 g of isomalt CRS in 4 mL of water R and dilute to 10.0 mL with the same solvent.<\/p>\n

Reference solution (b): Dissolve 10.0 mg of sorbitol CRS (impurity C) and 10.0 mg of mannitol CRS (impurity B) in 20 mL of water R and dilute to 100.0 mL with the same solvent.<\/p>\n

Precolumn:<\/p>\n

\u2014 size: l = 30 mm, \u00d8 = 4.6 mm;<\/p>\n

\u2014 stationary phase: strong cation-exchange resin (calcium form) R (9 \u03bcm);<\/p>\n

\u2014 temperature: 80 \u00b1 3 \u00b0C.<\/p>\n

Column:<\/p>\n

\u2014 size: l = 0.3 m, \u00d8 = 7.8 mm;<\/p>\n

\u2014 stationary phase: strong cation-exchange resin (calcium form) R (9 \u03bcm);<\/p>\n

\u2014 temperature: 80 \u00b1 3 \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. 40 \u00b0C).<\/p>\n

Injection: 20 \u03bcL.<\/p>\n

Run time: 2.5 times the retention time of 1,1-GPM.<\/p>\n

Relative retention: With reference to 1,1-GPM (retention time = about 14 min): 1,6-GPS = about 1.2; impurity B = about 1.6; impurity C = about 2.0.<\/p>\n

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

\u2014 resolution: minimum 2.0 between the peaks due to 1,1-GPM and 1,6-GPS.<\/p>\n

Limits:<\/p>\n

\u2014 impurities B, C: for each impurity, not more than the area of the corresponding peak in the chromatogram obtained with reference solution (b) (0.5 per cent);<\/p>\n

\u2014 unspecified impurities: for each impurity, not more than the area of the peak due to impurity C in the chromatogram obtained with reference solution (b) (0.5 per cent);<\/p>\n

\u2014 total: not more than 4 times the area of the peak due to impurity C in the chromatogram obtained with reference solution (b) (2.0 per cent);<\/p>\n

\u2014 disregard limit: 0.2 times the area of the peak due to impurity C in the chromatogram obtained with reference solution (b) (0.1 per cent).<\/p>\n

Water (2.5.12)<\/h3>\n

Maximum 7.0 per cent, determined on 0.300 g. As solvent, use a mixture of 20 mL of anhydrous methanol R and 20 mL of formamide R1 at 50 \u00b1 5 \u00b0C.<\/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: Test solution and reference solution (a).<\/p>\n

Calculate the percentage content of isomalt (1,1-GPM and 1,6-GPS) taking into account the assigned contents of 1,1-GPM and 1,6-GPS in isomalt CRS.<\/p>\n

LABELLING<\/h2>\n

The label states the percentage contents of 1,1-GPM and 1,6-GPS.<\/p>\n

IMPURITIES<\/h2>\n

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

\"Isomalt<\/p>\n

A. 6-O-\u03b1-D-glucopyranosyl-\u03b2-D-arabino-hex-2-ulofuranose (isomaltulose),<\/p>\n

\"Isomalt<\/p>\n

B. D-mannitol,<\/p>\n

\"Isomalt<\/p>\n

C. D-glucitol (D-sorbitol),<\/p>\n

\"Isomalt<\/p>\n

D. 1-O-\u03b1-D-glucopyranosyl-D-arabino-hex-2-ulofuranose (trehalulose).<\/p>\n

1 <\/sup>This monograph has undergone pharmacopoeial harmonisation. See chapter 5.8 Pharmacopoeial harmonisation.<\/p>\n","protected":false},"excerpt":{"rendered":"

Isomalt1 (Ph. Eur. monograph 1531) C12H24O11 344.3 C12H24O11,2H2O 380.3 Anhydrous isomalt 64519-82-0 Action and use Sweetening agent. DEFINITION Mixture of 6-O-\u03b1-D-glucopyranosyl-D-glucitol (6-O-\u03b1-D-glucopyranosyl-D-sorbitol; 1,6-GPS) and 1-O-\u03b1-D-glucopyranosyl-D- mannitol (1,1-GPM). Content 98.0 per cent to 102.0 per cent for the mixture of 1,6-GPS and 1,1-GPM and neither of the 2 components is less than 3.0 per cent (anhydrous…<\/p>\n","protected":false},"author":4,"featured_media":16898,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[174],"tags":[],"class_list":["post-16861","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\/16861","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=16861"}],"version-history":[{"count":4,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/16861\/revisions"}],"predecessor-version":[{"id":16908,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/16861\/revisions\/16908"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/16898"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=16861"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=16861"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=16861"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}