{"id":12106,"date":"2025-10-10T16:00:00","date_gmt":"2025-10-10T09:00:00","guid":{"rendered":"https:\/\/nhathuocngocanh.com\/bp\/?p=12106"},"modified":"2025-10-10T16:00:00","modified_gmt":"2025-10-10T09:00:00","slug":"dextran-70-for-injection","status":"publish","type":"post","link":"https:\/\/nhathuocngocanh.com\/bp\/dextran-70-for-injection\/","title":{"rendered":"Dextran 70 for Injection"},"content":{"rendered":"

(Ph. Eur. monograph 1001)<\/em><\/p>\n

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

Plasma substitute.<\/p>\n

Preparation<\/strong><\/p>\n

Dextran 70 Infusion<\/p>\n

DEFINITION<\/h2>\n

Mixture of polysaccharides, principally of the \u03b1-1,6-glucan type.<\/p>\n

Average relative molecular mass About 70 000.<\/p>\n

PRODUCTION<\/h2>\n

It is obtained by hydrolysis and fractionation of dextrans produced by fermentation of sucrose using Leuconostoc mesenteroides strain NRRL B-512 = CIP 78.59 or substrains thereof (for example L. mesenteroides B-512F = NCTC 10817).<\/p>\n

It is prepared in conditions designed to minimise the risk of microbial contamination.<\/p>\n

CHARACTERS<\/h2>\n

Appearance<\/h3>\n

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

Solubility<\/h3>\n

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

IDENTIFICATION<\/h2>\n

A. Specific optical rotation (2.2.7): + 195 to + 201 (dried substance).<\/p>\n

Dissolve 1.0 g in water R, heating on a water-bath, and dilute to 50.0 mL with the same solvent.<\/p>\n

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

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

C. Molecular-mass distribution (see Tests).<\/p>\n

TESTS<\/h2>\n

Solution S<\/h3>\n

Dissolve 5.0 g in distilled water R, heating on a water-bath, and dilute to 50 mL with the same solvent.<\/p>\n

Appearance of solution<\/h3>\n

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

Acidity or alkalinity<\/h3>\n

To 10 mL of solution S add 0.1 mL of phenolphthalein solution R. The solution remains colourless. Add 0.2 mL of 0.01 M sodium hydroxide. The solution is red. Add 0.4 mL of 0.01 M hydrochloric acid. The solution is colourless. Add 0.1 mL of methyl red solution R. The solution is red or orange.<\/p>\n

Nitrogen-containing substances<\/h3>\n

Maximum 110 ppm of N.<\/p>\n

Carry out the determination of nitrogen by sulfuric acid digestion (2.5.9), using 0.200 g and heating for 2 h. Collect the distillate in a mixture of 0.5 mL of bromocresol green solution R, 0.5 mL of methyl red solution R and 20 mL of water R.<\/p>\n

Titrate with 0.01 M hydrochloric acid. Not more than 0.15 mL of 0.01 M hydrochloric acid is required to change the colour of the indicator.<\/p>\n

Residual solvents<\/h3>\n

Gas chromatography (2.2.28).<\/p>\n

Internal standard propanol R.<\/p>\n

Test solution: Dissolve 5 g of the substance to be examined in 100 mL of water R and distil. Collect the first 45 mL of the distillate, add 1 mL of a 25 g\/L solution of propanol R and dilute to 50 mL with water R.<\/p>\n

Reference solution: Mix 0.5 mL of a 25 g\/L solution of anhydrous ethanol R, 0.5 mL of a 25 g\/L solution of propanol R and<\/p>\n

0.5 mL of a 2.5 g\/L solution of methanol R and dilute to 25.0 mL with water R.<\/p>\n

Column:<\/p>\n

\u2014 material: stainless steel;<\/p>\n

\u2014 size: l = 1.8 m, \u00d8 = 2 mm;<\/p>\n

\u2014 stationary phase: ethylvinylbenzene-divinylbenzene copolymer R (125-150 \u03bcm).<\/p>\n

Carrier gas nitrogen for chromatography R.<\/p>\n

Flow rate: 25 mL\/min.<\/p>\n

Temperature:<\/p>\n

\u2014 column: 190 \u00b0C;<\/p>\n

\u2014 injection port: 240 \u00b0C;<\/p>\n

\u2014 detector: 210 \u00b0C.<\/p>\n

Detection: Flame ionisation.<\/p>\n

Injection: The chosen volume of each solution.<\/p>\n

Limits:<\/p>\n

\u2014 ethanol: not more than the area of the corresponding peak in the chromatogram obtained with the reference solution (0.5 per cent);<\/p>\n

\u2014 methanol: not more than the area of the corresponding peak in the chromatogram obtained with the reference solution (0.05 per cent);<\/p>\n

\u2014 sum of solvents other than ethanol, methanol and propanol: not more than the area of the peak due to the internal standard (0.5 per cent, calculated as propanol).<\/p>\n

Molecular-mass distribution (2.2.39)<\/h3>\n

The average molecular mass (Mw<\/sub>) is 64 000 to 76 000. The average molecular mass of the 10 per cent high fraction is not greater than 185 000. The average molecular mass of the 10 per cent low fraction is not less than 15 000.<\/p>\n

Loss on drying (2.2.32)<\/h3>\n

Maximum 7.0 per cent, determined on 0.200 g by heating in an oven at 105 \u00b1 2 \u00b0C for 5 h.<\/p>\n

Sulfated ash (2.4.14)<\/h3>\n

Maximum 0.3 per cent, determined on 0.50 g.<\/p>\n

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

Less than 16 IU\/g.<\/p>\n

Microbial contamination<\/h3>\n

TAMC: acceptance criterion 10 CFU\/g (2.6.12).<\/p>\n","protected":false},"excerpt":{"rendered":"

(Ph. Eur. monograph 1001) Action and use Plasma substitute. Preparation Dextran 70 Infusion DEFINITION Mixture of polysaccharides, principally of the \u03b1-1,6-glucan type. Average relative molecular mass About 70 000. PRODUCTION It is obtained by hydrolysis and fractionation of dextrans produced by fermentation of sucrose using Leuconostoc mesenteroides strain NRRL B-512 = CIP 78.59 or substrains…<\/p>\n","protected":false},"author":4,"featured_media":12131,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[174],"tags":[],"class_list":["post-12106","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\/12106","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=12106"}],"version-history":[{"count":2,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/12106\/revisions"}],"predecessor-version":[{"id":12133,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/12106\/revisions\/12133"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/12131"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=12106"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=12106"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=12106"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}