{"id":13832,"date":"2025-10-14T11:23:05","date_gmt":"2025-10-14T04:23:05","guid":{"rendered":"https:\/\/nhathuocngocanh.com\/bp\/?p=13832"},"modified":"2025-10-14T11:23:05","modified_gmt":"2025-10-14T04:23:05","slug":"erythritol","status":"publish","type":"post","link":"https:\/\/nhathuocngocanh.com\/bp\/erythritol\/","title":{"rendered":"Erythritol"},"content":{"rendered":"

(Ph. Eur. monograph 1803)<\/em><\/p>\n

C4<\/sub>H10<\/sub>O4<\/sub> 122.1 149-32-6<\/p>\n

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

Excipient.<\/p>\n

DEFINITION<\/h2>\n

(2R,3S)-Butane-1,2,3,4-tetrol (meso-erythritol).<\/p>\n

Content<\/h3>\n

96.0 per cent to 102.0 per cent (anhydrous substance).<\/p>\n

CHARACTERS<\/h2>\n

Appearance<\/h3>\n

White or almost white, crystalline powder or free-flowing granules.<\/p>\n

Solubility<\/h3>\n

Freely soluble in water, very slightly soluble in ethanol (96 per cent).<\/p>\n

IDENTIFICATION<\/h2>\n

A. Melting point (2.2.14): 119 \u00b0C to 122 \u00b0C.<\/p>\n

B. Infrared absorption spectrophotometry (2.2.24).<\/p>\n

Comparison: erythritol CRS.<\/p>\n

TESTS<\/h2>\n

Appearance of solution<\/h3>\n

The solution is clear (2.2.1) and colourless (2.2.2, Method II).<\/p>\n

Dissolve 5.0 g in water R and dilute to 50 mL with the same solvent.<\/p>\n

Conductivity (2.2.38)<\/h3>\n

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

Dissolve 20.0 g in carbon dioxide-free water R prepared from distilled water R 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

Related substances<\/h3>\n

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

Test solution: Dissolve 0.50 g of the substance to be examined in water R and dilute to 10.0 mL with the same solvent.<\/p>\n

Reference solution (a): Dissolve 0.50 g of erythritol CRS in water R and dilute to 10.0 mL with the same solvent.<\/p>\n

Reference solution (b): Dilute 2.0 mL of the test solution to 100.0 mL with water R.<\/p>\n

Reference solution (c): Dilute 5.0 mL of reference solution (b) to 100.0 mL with water R.Reference solution (d) Dissolve 1.0 g of erythritol R and 1.0 g of glycerol R in water R and dilute to 20 mL with the same solvent.<\/p>\n

Column:<\/p>\n

\u2014 size: l = 0.3 m, \u00d8 = 8.0 mm;<\/p>\n

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

\u2014 temperature: 70 \u00b0C.<\/p>\n

Mobile phase 0.01 per cent V\/V solution of sulfuric acid R.<\/p>\n

Flow rate: 0.8 mL\/min.<\/p>\n

Detection: Differential refractometer maintained at a constant temperature (e.g. 35 \u00b0C).<\/p>\n

Injection: 20 \u03bcL of the test solution and reference solutions (b), (c) and (d).<\/p>\n

Run time: 3 times the retention time of erythritol.<\/p>\n

Relative retention: With reference to erythritol (retention time = about 11 min): impurity A = about 0.77; impurity B = about 0.90; impurity C = about 0.94; impurity D = about 1.10.<\/p>\n

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

\u2014 resolution: minimum 2.0 between the peaks due to erythritol and impurity D.<\/p>\n

Limits:<\/p>\n

\u2014 any impurity: not more than the area of the principal peak in the chromatogram obtained with reference solution (b) (2.0 per cent);<\/p>\n

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

\u2014 disregard limit: area of the principal peak in the chromatogram obtained with reference solution (c) (0.1 per cent).<\/p>\n

Water (2.5.12)<\/h3>\n

Maximum 0.5 per cent, determined on 1.00 g.<\/p>\n

Microbial contamination<\/h3>\n

If intended for use in the manufacture of parenteral preparations:<\/p>\n

\u2014 TAMC: acceptance criterion 10 CFU\/g (2.6.12).<\/p>\n

If not intended for use in the manufacture of parenteral preparations:<\/p>\n

\u2014 TAMC: acceptance criterion 10 CFU\/g (2.6.12);<\/p>\n

\u2014 TYMC: acceptance criterion 10 CFU\/g (2.6.12);<\/p>\n

\u2014 absence of Escherichia coli (2.6.13);<\/p>\n

\u2014 absence of Salmonella (2.6.13).<\/p>\n

Bacterial endotoxins (2.6.14)<\/h3>\n

If intended for use in the manufacture of parenteral preparations without a further appropriate procedure for the removal of bacterial endotoxins:<\/p>\n

\u2014 less than 4 IU\/g for parenteral preparations having a concentration of 100 g\/L or less of erythritol;<\/p>\n

\u2014 less than 2.5 IU\/g for parenteral preparations having a concentration of more than 100 g\/L of erythritol.<\/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 C4H10O4 taking into account the assigned content of erythritol CRS.<\/p>\n

LABELLING<\/h2>\n

The label states where applicable, that the substance is suitable for use in the manufacture of parenteral preparations.<\/p>\n

IMPURITIES<\/h2>\n

\"Erythritol<\/p>\n

A. 4-O-\u03b1-D-glucopyranosyl-D-glucitol (D-maltitol),<\/p>\n

\"Erythritol<\/p>\n

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

\"Erythritol<\/p>\n

C. (2R,3s,4S)-pentane-1,2,3,4,5-pentol (meso-ribitol),<\/p>\n

\"Erythritol<\/p>\n

D. propane-1,2,3-triol (glycerol).<\/p>\n","protected":false},"excerpt":{"rendered":"

(Ph. Eur. monograph 1803) C4H10O4 122.1 149-32-6 Action and use Excipient. DEFINITION (2R,3S)-Butane-1,2,3,4-tetrol (meso-erythritol). Content 96.0 per cent to 102.0 per cent (anhydrous substance). CHARACTERS Appearance White or almost white, crystalline powder or free-flowing granules. Solubility Freely soluble in water, very slightly soluble in ethanol (96 per cent). IDENTIFICATION A. Melting point (2.2.14): 119 \u00b0C…<\/p>\n","protected":false},"author":4,"featured_media":13834,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[174],"tags":[],"class_list":["post-13832","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\/13832","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=13832"}],"version-history":[{"count":3,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/13832\/revisions"}],"predecessor-version":[{"id":13850,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/13832\/revisions\/13850"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/13834"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=13832"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=13832"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=13832"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}