{"id":14276,"date":"2025-10-15T09:45:19","date_gmt":"2025-10-15T02:45:19","guid":{"rendered":"https:\/\/nhathuocngocanh.com\/bp\/?p=14276"},"modified":"2025-10-15T09:45:19","modified_gmt":"2025-10-15T02:45:19","slug":"glycerol-distearate","status":"publish","type":"post","link":"https:\/\/nhathuocngocanh.com\/bp\/glycerol-distearate\/","title":{"rendered":"Glycerol Distearate"},"content":{"rendered":"

(Ph. Eur. monograph 1428)<\/p>\n

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

Excipient.<\/p>\n

DEFINITION<\/h2>\n
Mixture of diacylglycerols, mainly distearoylglycerol, together with variable quantities of mono- and triacylglycerols. It is obtained by partial glycerolysis of vegetable oils containing triacylglycerols of palmitic (hexadecanoic) and stearic (octadecanoic) acids or by esterification of glycerol with stearic acid. The fatty acids may be of vegetable or animal origin.<\/p>\n
Content<\/h3>\n
\u2014 monoacylglycerols: 8.0 per cent to 22.0 per cent;<\/p>\n
\u2014 diacylglycerols: 40.0 per cent to 60.0 per cent;<\/p>\n
\u2014 triacylglycerols: 25.0 per cent to 35.0 per cent.<\/p>\n
CHARACTERS<\/h2>\n
Appearance<\/h3>\n
Hard, waxy mass or powder, or white or almost white, unctuous flakes.<\/p>\n
Solubility<\/h3>\n
Practically insoluble in water, soluble in methylene chloride, partly soluble in hot ethanol (96 per cent).<\/p>\n
IDENTIFICATION<\/h2>\n
A. Melting point (2.2.14): 50 \u00b0C to 60 \u00b0C (types I and II), 50 \u00b0C to 70 \u00b0C (type III).<\/p>\n
B. Composition of fatty acids (see Tests) according to the type stated on the label.<\/p>\n
C. It complies with the limits of the assay (diacylglycerol content).<\/p>\n
TESTS<\/h2>\n
Acid value (2.5.1)<\/h4>\n
Maximum 6.0, determined on 1.0 g.<\/p>\n
Use a mixture of equal volumes of ethanol (96 per cent) R and toluene R as solvent and heat gently.<\/p>\n
Iodine value (2.5.4, Method A)<\/h4>\n
Maximum 3.0.<\/p>\n
Saponification value (2.5.6)<\/h4>\n
165 to 195, determined on 2.0 g. Carry out the titration with heating.<\/p>\n
Free glycerol<\/h3>\n
Maximum 1.0 per cent, determined as described under Assay.<\/p>\n
Composition of fatty acids (2.4.22, Method C)<\/h4>\n
Use the mixture of calibrating substances in Table 2.4.22.-1.<\/p>\n
Composition of the fatty-acid fraction of the substance:<\/p>\n\n\n\n\n\n\n
Glycerol distearate<\/td>\n Composition of fatty acids<\/td>\n<\/tr>\n
Type I<\/td>\n Stearic acid: 40.0 per cent to 60.0 per cent<\/p>\n
Sum of the contents of palmitic and stearic acids: minimum 90.0 per cent<\/td>\n<\/tr>\n
Type II<\/td>\n Stearic acid: 60.0 per cent to 80.0 per cent<\/p>\n
Sum of the contents of palmitic and stearic acids: minimum 90.0 per cent<\/td>\n<\/tr>\n
Type III<\/td>\n Stearic acid: 80.0 per cent to 99.0 per cent<\/p>\n
Sum of the contents of palmitic and stearic acids: minimum 96.0 per cent<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n
Water (2.5.12)<\/h4>\n
Maximum 1.0 per cent, determined on 1.00 g. Use pyridine R as the solvent.<\/p>\n
Total ash (2.4.16)<\/h4>\n
Maximum 0.1 per cent.<\/p>\n
ASSAY<\/h2>\n
Size-exclusion chromatography (2.2.30).<\/p>\n
Test solution: Into a 15 mL flask, weigh 0.200 g (m) of the substance to be examined. Add 5.0 mL of tetrahydrofuran R and shake to dissolve. Reweigh the flask and calculate the total mass of solvent and substance (M).<\/p>\n
Reference solutions: Into three 15 mL flasks, respectively weigh 2.0 mg, 5.0 mg and 10.0 mg of glycerol R and add 5.0 mL of tetrahydrofuran R to each flask. Into a 4 flask, weigh 2.0 mg of glycerol R and add 10.0 mL of tetrahydrofuran R. Weigh the flasks again and calculate the concentration of glycerol in milligrams per gram for each reference solution.<\/p>\n
Column:<\/p>\n
\u2014 size: l = 0.6 m, \u00d8 = 7 mm;<\/p>\n
\u2014 stationary phase: styrene-divinylbenzene copolymer R (5 \u03bcm) with a pore size of 10 nm.<\/p>\n
Mobile phase: tetrahydrofuran R.<\/p>\n
Flow rate: 1 mL\/min.<\/p>\n
Detection: Differential refractometer.<\/p>\n
Injection: 40 \u03bcL.<\/p>\n
Relative retention: With reference to glycerol (retention time = about 15 min): triacylglycerols = about 0.75; diacylglycerols = about 0.80; monoacylglycerols and free fatty acids = about 0.85.<\/p>\n
Calculations:<\/p>\n
\u2014 free glycerol: from the calibration curve obtained with the reference solutions, determine the concentration (C) in milligrams per gram in the test solution and calculate the percentage content (A) in the substance to be examined using the following expression:<\/p>\n
C x M\/m x 10<\/p>\n
\u2014 free fatty acids: calculate the percentage content of free fatty acids (D) using the following expression:<\/p>\n
I_{A\u00a0<\/sub>x 270\/561.1<\/p>\n}
I_{A<\/sub> = acid value;<\/p>\n}
\u2014 monoacylglycerols: calculate the percentage content of monoacylglycerols using the following expression:<\/p>\n
$\"Glycerol$ <\/p>\n
B = percentage content of water (see Tests);<\/p>\n
X = area of the peak due to monoacylglycerols and free fatty acids;<\/p>\n
Y = area of the peak due to diacylglycerols;<\/p>\n
Z = area of the peak due to triacylglycerols;<\/p>\n
\u2014 diacylglycerols: calculate the percentage content of diacylglycerols using the following expression:<\/p>\n
$\"Glycerol$ <\/p>\n
\u2014 triacylglycerols: calculate the percentage content of triacylglycerols using the following expression:<\/p>\n
$\"Glycerol$ <\/p>\n
LABELLING<\/p>\n
The label states the type of glycerol distearate.<\/p>\n","protected":false},"excerpt":{"rendered":"
(Ph. Eur. monograph 1428) Action and use Excipient. DEFINITION Mixture of diacylglycerols, mainly distearoylglycerol, together with variable quantities of mono- and triacylglycerols. It is obtained by partial glycerolysis of vegetable oils containing triacylglycerols of palmitic (hexadecanoic) and stearic (octadecanoic) acids or by esterification of glycerol with stearic acid. The fatty acids may be of vegetable…<\/p>\n","protected":false},"author":2,"featured_media":14299,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[174],"tags":[],"class_list":["post-14276","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\/14276","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=14276"}],"version-history":[{"count":2,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/14276\/revisions"}],"predecessor-version":[{"id":14303,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/14276\/revisions\/14303"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/14299"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=14276"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=14276"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=14276"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}

Glycerol distearate<\/td>\n	Composition of fatty acids<\/td>\n<\/tr>\n
Type I<\/td>\n	Stearic acid: 40.0 per cent to 60.0 per cent<\/p>\n Sum of the contents of palmitic and stearic acids: minimum 90.0 per cent<\/td>\n<\/tr>\n
Type II<\/td>\n	Stearic acid: 60.0 per cent to 80.0 per cent<\/p>\n Sum of the contents of palmitic and stearic acids: minimum 90.0 per cent<\/td>\n<\/tr>\n
Type III<\/td>\n	Stearic acid: 80.0 per cent to 99.0 per cent<\/p>\n Sum of the contents of palmitic and stearic acids: minimum 96.0 per cent<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n Water (2.5.12)<\/h4>\n Maximum 1.0 per cent, determined on 1.00 g. Use pyridine R as the solvent.<\/p>\n Total ash (2.4.16)<\/h4>\n Maximum 0.1 per cent.<\/p>\n ASSAY<\/h2>\n Size-exclusion chromatography (2.2.30).<\/p>\n Test solution: Into a 15 mL flask, weigh 0.200 g (m) of the substance to be examined. Add 5.0 mL of tetrahydrofuran R and shake to dissolve. Reweigh the flask and calculate the total mass of solvent and substance (M).<\/p>\n Reference solutions: Into three 15 mL flasks, respectively weigh 2.0 mg, 5.0 mg and 10.0 mg of glycerol R and add 5.0 mL of tetrahydrofuran R to each flask. Into a 4 flask, weigh 2.0 mg of glycerol R and add 10.0 mL of tetrahydrofuran R. Weigh the flasks again and calculate the concentration of glycerol in milligrams per gram for each reference solution.<\/p>\n Column:<\/p>\n \u2014 size: l = 0.6 m, \u00d8 = 7 mm;<\/p>\n \u2014 stationary phase: styrene-divinylbenzene copolymer R (5 \u03bcm) with a pore size of 10 nm.<\/p>\n Mobile phase: tetrahydrofuran R.<\/p>\n Flow rate: 1 mL\/min.<\/p>\n Detection: Differential refractometer.<\/p>\n Injection: 40 \u03bcL.<\/p>\n Relative retention: With reference to glycerol (retention time = about 15 min): triacylglycerols = about 0.75; diacylglycerols = about 0.80; monoacylglycerols and free fatty acids = about 0.85.<\/p>\n Calculations:<\/p>\n \u2014 free glycerol: from the calibration curve obtained with the reference solutions, determine the concentration (C) in milligrams per gram in the test solution and calculate the percentage content (A) in the substance to be examined using the following expression:<\/p>\n C x M\/m x 10<\/p>\n \u2014 free fatty acids: calculate the percentage content of free fatty acids (D) using the following expression:<\/p>\n I_{A\u00a0<\/sub>x 270\/561.1<\/p>\n} I_{A<\/sub> = acid value;<\/p>\n} \u2014 monoacylglycerols: calculate the percentage content of monoacylglycerols using the following expression:<\/p>\n $\"Glycerol$ <\/p>\n B = percentage content of water (see Tests);<\/p>\n X = area of the peak due to monoacylglycerols and free fatty acids;<\/p>\n Y = area of the peak due to diacylglycerols;<\/p>\n Z = area of the peak due to triacylglycerols;<\/p>\n \u2014 diacylglycerols: calculate the percentage content of diacylglycerols using the following expression:<\/p>\n $\"Glycerol$ <\/p>\n \u2014 triacylglycerols: calculate the percentage content of triacylglycerols using the following expression:<\/p>\n $\"Glycerol$ <\/p>\n LABELLING<\/p>\n The label states the type of glycerol distearate.<\/p>\n","protected":false},"excerpt":{"rendered":" (Ph. Eur. monograph 1428) Action and use Excipient. DEFINITION Mixture of diacylglycerols, mainly distearoylglycerol, together with variable quantities of mono- and triacylglycerols. It is obtained by partial glycerolysis of vegetable oils containing triacylglycerols of palmitic (hexadecanoic) and stearic (octadecanoic) acids or by esterification of glycerol with stearic acid. The fatty acids may be of vegetable…<\/p>\n","protected":false},"author":2,"featured_media":14299,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[174],"tags":[],"class_list":["post-14276","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\/14276","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=14276"}],"version-history":[{"count":2,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/14276\/revisions"}],"predecessor-version":[{"id":14303,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/14276\/revisions\/14303"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/14299"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=14276"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=14276"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=14276"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}

Content<\/h3>\n\u2014 monoacylglycerols: 8.0 per cent to 22.0 per cent;<\/p>\n\u2014 diacylglycerols: 40.0 per cent to 60.0 per cent;<\/p>\n\u2014 triacylglycerols: 25.0 per cent to 35.0 per cent.<\/p>\n

CHARACTERS<\/h2>\n

Appearance<\/h3>\nHard, waxy mass or powder, or white or almost white, unctuous flakes.<\/p>\n

Solubility<\/h3>\nPractically insoluble in water, soluble in methylene chloride, partly soluble in hot ethanol (96 per cent).<\/p>\n

TESTS<\/h2>\n

Acid value (2.5.1)<\/h4>\nMaximum 6.0, determined on 1.0 g.<\/p>\nUse a mixture of equal volumes of ethanol (96 per cent) R and toluene R as solvent and heat gently.<\/p>\n

Iodine value (2.5.4, Method A)<\/h4>\nMaximum 3.0.<\/p>\n

Saponification value (2.5.6)<\/h4>\n165 to 195, determined on 2.0 g. Carry out the titration with heating.<\/p>\n

Free glycerol<\/h3>\nMaximum 1.0 per cent, determined as described under Assay.<\/p>\n

Water (2.5.12)<\/h4>\nMaximum 1.0 per cent, determined on 1.00 g. Use pyridine R as the solvent.<\/p>\n

Total ash (2.4.16)<\/h4>\nMaximum 0.1 per cent.<\/p>\n

Content<\/h3>\n
\u2014 monoacylglycerols: 8.0 per cent to 22.0 per cent;<\/p>\n
\u2014 diacylglycerols: 40.0 per cent to 60.0 per cent;<\/p>\n
\u2014 triacylglycerols: 25.0 per cent to 35.0 per cent.<\/p>\n

Appearance<\/h3>\n
Hard, waxy mass or powder, or white or almost white, unctuous flakes.<\/p>\n

Solubility<\/h3>\n
Practically insoluble in water, soluble in methylene chloride, partly soluble in hot ethanol (96 per cent).<\/p>\n

Acid value (2.5.1)<\/h4>\n
Maximum 6.0, determined on 1.0 g.<\/p>\n
Use a mixture of equal volumes of ethanol (96 per cent) R and toluene R as solvent and heat gently.<\/p>\n

Iodine value (2.5.4, Method A)<\/h4>\n
Maximum 3.0.<\/p>\n

Saponification value (2.5.6)<\/h4>\n
165 to 195, determined on 2.0 g. Carry out the titration with heating.<\/p>\n

Free glycerol<\/h3>\n
Maximum 1.0 per cent, determined as described under Assay.<\/p>\n

Water (2.5.12)<\/h4>\n
Maximum 1.0 per cent, determined on 1.00 g. Use pyridine R as the solvent.<\/p>\n

Total ash (2.4.16)<\/h4>\n
Maximum 0.1 per cent.<\/p>\n