{"id":26496,"date":"2025-11-05T17:09:03","date_gmt":"2025-11-05T10:09:03","guid":{"rendered":"https:\/\/nhathuocngocanh.com\/bp\/?p=26496"},"modified":"2025-11-06T17:12:21","modified_gmt":"2025-11-06T10:12:21","slug":"omega-3-marine-triglycerides","status":"publish","type":"post","link":"https:\/\/nhathuocngocanh.com\/bp\/omega-3-marine-triglycerides\/","title":{"rendered":"Omega-3-Marine Triglycerides"},"content":{"rendered":"

Edition: BP 2025 (Ph. Eur. 11.6 update)<\/p>\n

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

Lipid-regulating drug.<\/p>\n

\n
Ph Eur<\/p>\n
DEFINITION<\/h2>\n
Mixture of mono-, di- and triesters of omega-3 acids with glycerol, containing mainly triesters and obtained either by esterification of concentrated and purified (e.g. by molecular distillation) omega-3 acids with glycerol or by transesterification of the concentrated and purified (e.g. by molecular distillation) omega-3 acid ethyl esters with glycerol. The origin of the omega-3 acids is the body oil obtained from fish of families such as Engraulidae, Carangidae, Clupeidae, Osmeridae, Salmonidae and Scombridae or from animals of the class Cephalopoda. The omega-3 acids are identified as the following acids: alpha-linolenic acid (C18:3 n- 3), moroctic acid (C18:4 n-3), eicosatetraenoic acid (C20:4 n-3), timnodonic (eicosapentaenoic) acid (C20:5 n-3; EPA), heneicosapentaenoic acid (C21:5 n-3), clupanodonic acid (C22:5 n-3) and cervonic (docosahexaenoic) acid (C22:6 n-3; DHA).<\/p>\n
Content<\/p>\n
\u2014 sum of the contents of the omega-3 acids EPA and DHA, expressed as triglycerides: minimum 45 per cent;<\/p>\n
\u2014 total omega-3 acids, expressed as triglycerides: minimum 60 per cent.<\/p>\n
A suitable antioxidant may be added.<\/p>\n
PRODUCTION<\/h2>\n
The content of dioxins and dioxin-like PCBs (polychlorinated biphenyls) is controlled using methods and limits in accordance with the requirements set in the European Union or other applicable regulations.<\/p>\n
CHARACTERS<\/h2>\n
Appearance<\/h3>\n
Pale yellow liquid.<\/p>\n
Solubility<\/h3>\n
Practically insoluble in water, very soluble in acetone and in heptane, slightly soluble in anhydrous ethanol.<\/p>\n
IDENTIFICATION<\/h2>\n
Examine the chromatograms obtained in the assay for EPA and DHA.<\/p>\n
Results\u00a0 The peaks due to eicosapentaenoic acid methyl ester and docosahexaenoic acid methyl ester in the chromatogram obtained with test solution (b) are similar in retention time to the corresponding peaks in the chromatograms obtained with reference solutions (a1) and (a2).<\/p>\n
TESTS<\/h2>\n
Absorbance (2.2.25)<\/strong><\/p>\n
Maximum 0.70 at 233 nm.<\/p>\n
Dilute 0.300 g to 50.0 mL with trimethy lpentane R. Dilute 2.0 mL of the solution to 50.0 mL with trimethy lpentane R.<\/p>\n
Acid value (2.5.1)<\/strong><\/p>\n
Maximum 3.0, determined on 10.0 g in 50 mL of the prescribed mixture of solvents.<\/p>\n
Anisidine value (2.5.36)<\/strong><\/p>\n
Maximum 20.0.<\/p>\n
Peroxide value (2.5.5, Method A) Maximum 5.0.<\/p>\n
Oligomers, triglycerides, ethyl esters and free fatty acids<\/h3>\n
Size-exclusion chromatography (2.2.30).<\/p>\n
Test solution\u00a0 Dilute 50.0 mg of the substance to be examined to 10.0 mL with tetrahydrofuran R.<\/p>\n
Reference solution\u00a0 Dissolve 50 mg of monodocosahexaenoin R, 30 mg of didocosahexaenoin R and 20 mg of tridocosahexaenoin R in tetrahydrofuran R and dilute to 100.0 mL with the same solvent.<\/p>\n
Column\u00a0 3 columns to be connected in series:<\/p>\n
\u2014 size: l = 0.3 m, \u00d8 = 7.8 mm;<\/p>\n
\u2014 stationary phase: styrene-divinylbenzene copolymer R (5 \u00b5m) with the following pore sizes:<\/p>\n
\u2014 column 1: 50 nm;<\/p>\n
\u2014 column 2: 10 nm;<\/p>\n
\u2014 column 3: 5 nm;<\/p>\n
\u2014 connection sequence: injector – column 1 – column 2 – column 3 – detector.<\/p>\n
Mobile phase tetrahydrofuran R. Flow rate 0.8 mL\/min.<\/p>\n
Detection\u00a0 Differential refractometer.<\/p>\n
Injection\u00a0 40 \u00b5L.<\/p>\n
System suitability\u00a0 Reference solution:<\/p>\n
\u2014 elution order: tridocosahexaenoin, didocosahexaenoin, monodocosahexaenoin;<\/p>\n
\u2014 resolution: minimum 2.0 between the peaks due to didocosahexaenoin and monodocosahexaenoin; minimum 1.0 between the peaks due to tridocosahexaenoin and didocosahexaenoin.<\/p>\n
Identify the peaks using the chromatogram shown in Figure 1352.-1. Calculate the percentage content of oligomers using the following expression:<\/p>\n
B\/A \u00d7 100<\/p>\n
A = sum of the areas of all the peaks in the chromatogram;<\/p>\n
B = area of the peak with a retention time less than the retention time of the peak due to the triglycerides.<\/p>\n
Calculate the percentage content of triglycerides using the following expression:<\/p>\n
C\/A\u00d7 100<\/p>\n
A = sum of the areas of all the peaks in the chromatogram;<\/p>\n
C = (sum of the) area(s) of the peak(s) due to triglycerides.<\/p>\n
Calculate the percentage content of ethyl esters and free fatty acids using the following expression:<\/p>\n
D\/A \u00d7 100<\/p>\n
A = sum of the areas of all the peaks in the chromatogram;<\/p>\n
D = (sum of the) area(s) of the peak(s) due to ethyl esters and free fatty acids.<\/p>\n
$\"Omega-3-Marine$ <\/p>\n
1. oligomers 2. triglycerides 3. diglycerides 4. monoglycerides 5. ethyl esters and free fatty acids<\/p>\n
Figure 1352.-1. \u2013 Chromatogram for the test for oligomers, triglycerides, ethyl esters and free fatty acids in omega-3 acids triglycerides<\/p>\n
Limits:<\/p>\n
\u2014 oligomers: maximum 3.0 per cent;<\/p>\n
\u2014 triglycerides: minimum 50.0 per cent;<\/p>\n
\u2014 ethyl esters and free fatty acids: maximum 5.0 per cent.<\/p>\n
ASSAY<\/h2>\n
EPA and DHA (2.4.29)<\/p>\n
For identification of the peaks, see Figure 1352.-2.<\/p>\n
$\"Omega-3-Marine$ <\/p>\n\n\n\n\n\n
1. C14:0<\/td>\n 4. C16:4n-1<\/td>\n 7. C18:1n-7<\/td>\n 10. C18:4n-3<\/td>\n 13. C20:1n-9<\/td>\n 16. C20:4n-6<\/td>\n 19. C22:0<\/td>\n 22. C21:5n-3<\/td>\n 25. DHA<\/td>\n<\/tr>\n
2. C16:0<\/td>\n 5. C18:0<\/td>\n 8. C18:2n-6<\/td>\n 11. C20:0<\/td>\n 14. C20:1n-7<\/td>\n 17. C20:4n-3<\/td>\n 20. C22:1n-11<\/td>\n 23. C22:5n-6<\/td>\n 26. C24:1n-9<\/td>\n<\/tr>\n
3. C16:1n-7<\/td>\n 6. C18:1n-9<\/td>\n 9. C18:3n-3<\/td>\n 12. C20:1n-11<\/td>\n 15. C20:2n-6<\/td>\n 18. EPA<\/td>\n 21. C22:1n-9<\/td>\n 24. C22:5n-3<\/td>\n <\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n
Figure 1352.-2. \u2013 Chromatogram for the assays of omega-3 acids in omega-3 acids triglycerides<\/p>\n
Total omega-3 acids (2.4.29) See Figure 1352.-2.<\/p>\n
STORAGE<\/h2>\n
Under an inert gas, in a well-filled, airtight container, protected from light. Ph Eur<\/p>\n","protected":false},"excerpt":{"rendered":"
Edition: BP 2025 (Ph. Eur. 11.6 update) Action and use Lipid-regulating drug. Ph Eur DEFINITION Mixture of mono-, di- and triesters of omega-3 acids with glycerol, containing mainly triesters and obtained either by esterification of concentrated and purified (e.g. by molecular distillation) omega-3 acids with glycerol or by transesterification of the concentrated and purified (e.g….<\/p>\n","protected":false},"author":5,"featured_media":26497,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[174],"tags":[],"class_list":["post-26496","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\/26496","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\/5"}],"replies":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/comments?post=26496"}],"version-history":[{"count":5,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/26496\/revisions"}],"predecessor-version":[{"id":27266,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/26496\/revisions\/27266"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/26497"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=26496"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=26496"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=26496"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}

PRODUCTION<\/h2>\nThe content of dioxins and dioxin-like PCBs (polychlorinated biphenyls) is controlled using methods and limits in accordance with the requirements set in the European Union or other applicable regulations.<\/p>\n

CHARACTERS<\/h2>\n

Appearance<\/h3>\nPale yellow liquid.<\/p>\n

Solubility<\/h3>\nPractically insoluble in water, very soluble in acetone and in heptane, slightly soluble in anhydrous ethanol.<\/p>\n

PRODUCTION<\/h2>\n
The content of dioxins and dioxin-like PCBs (polychlorinated biphenyls) is controlled using methods and limits in accordance with the requirements set in the European Union or other applicable regulations.<\/p>\n

Appearance<\/h3>\n
Pale yellow liquid.<\/p>\n

Solubility<\/h3>\n
Practically insoluble in water, very soluble in acetone and in heptane, slightly soluble in anhydrous ethanol.<\/p>\n