Fish Oil Concentrate, EPA & DHA

Fish oil concentrate, EPA and DHA reference formula with example amounts of 2,000 mg, 700 mg and 500 mg per serving, developed as a softgel.

Fish Oil Concentrate, EPA & DHA is a reference formula for brands building a concentrated marine omega-3 softgel, with the oil, EPA and DHA declared by weight. The example serving carries 2,000 mg of fish oil concentrate, 700 mg of EPA and 500 mg of DHA in two softgels, and the brand sets the final amounts, the EPA to DHA ratio and the oil form for its market.

A softgel is the only format on the reference labels. The reference labels also declare docosapentaenoic acid, olive polyphenols and sesame lignans next to the three core ingredients, so the development work centers on the omega-3 concentration of the oil, the oil form, and the oxidation stability of a concentrated oil in the shell.

Ingredient Composition

IngredientPer ServingRaw Material FormAlternative Form (same amount of active)
Fish Oil Concentrate2000 mg (example amount)Concentrated marine fish oil; specification 2,000 mg oil per serving, with omega-3 concentration, oil form and oxidation limits set with the supplierA higher-concentration oil at an adjusted weight, or an algal oil for the DHA share
EPA700 mg (example amount)Eicosapentaenoic acid supplied by the concentrateA separately sourced EPA oil at the same EPA weight
DHA500 mg (example amount)Docosahexaenoic acid supplied by the concentrateAlgal DHA at the same weight

The amounts are as declared on the label: the oil is the weight of the concentrate, and EPA and DHA are the fatty acids within it, so the three rows describe one oil. The reference label also declares docosapentaenoic acid at 78 mg, polyphenols from olive at 300 mg and sesame lignan extract at 10 mg. Whether the fatty acids are in triglyceride, ethyl ester or free form is set in the specification, since the form changes how the declared amount is measured.

Intended Benefits & Formula Rationale

This formula is designed for products positioned around heart and circulatory nutrition and concentrated marine omega-3 intake. The fish oil concentrate is included as the carrier of EPA and DHA so that the oil form, the concentration and the softgel can be set together.

Intended Benefit DirectionKey IngredientsFormulation Rationale
Concentrated marine omega-3 intakeFish Oil Concentrate, EPA, DHAIncluded as a source of long-chain omega-3 fatty acids at a concentration of about 600 mg of EPA and DHA per gram of oil in the example. Evidence: Product positioning
Triglycerides and heart healthFish Oil Concentrate, EPA, DHAA Cochrane review found that increasing long-chain omega-3 fats reduced serum triglycerides by about 15% in a dose-dependent way (high-certainty evidence) and slightly reduced the risk of coronary heart disease mortality and events (moderate- and low-certainty evidence) [1]. Evidence: Referenced

Development starts from these example amounts, and the brand fixes the final amounts and the format for its market.

Available Formats

The reference formula is built for a softgel version; counts per serving are design choices that the brand can adjust.

FormatUnitPer ServingPack SizeOther Ingredients (typical)Suitability
Softgel2 softgels2000 mg fish oil concentrate + 700 mg EPA + 500 mg DHA60 or 120 softgelsGelatin or plant-based shell, glycerin, antioxidantLead format; oil fill suits a concentrated omega-3

Raw Material Input & Fill (Design Estimate)

Design estimates. The oil is assumed at 100% of the declared weight and a density of 0.92 g/mL, so 1,000 mg of concentrate per softgel fills about 1.1 mL, and EPA and DHA are counted inside the concentrate.

FormatRaw Material Input per UnitDesign FillBalance for ExcipientsVerification Before Scale-Up
Softgel1000 mg concentrate per softgel (350 mg EPA, 250 mg DHA)About 1,150 mg fill in a size 20 oblong softgelAbout 150 mg antioxidant and minor componentsFill weight variation, leak test, peroxide and anisidine value, fatty acid assay

Liquid, gummy and capsule versions are separate projects, because a concentrated oil needs its own dosing and stability plan in those formats.

Formulation Considerations

Oxidation. Marine omega-3 oils are highly prone to oxidation, oxidized oils may have altered biological activity, and the peroxide value and anisidine value can show the oxidative state [2]. Both values are written into the specification with limits, and the antioxidant system is chosen for the concentrated oil.
Oil form and declaration. Triglyceride, ethyl ester and free fatty acid forms differ in how the omega-3 amount is measured. The specification states the form, and the EPA and DHA values on the label are taken from a fatty acid assay of the finished unit.
Softgel size. A 2,000 mg serving of concentrate needs two softgels of about 1,150 mg fill each. The shell size, the shell type and the swallowing size are chosen with the brand.
Evidence and claims. The cited triglyceride and heart outcomes depend on the omega-3 dose and type [1], so claims on a finished product are reviewed for each sales market before a product is developed.

Customization Options

Brands adjust the oil concentration, the EPA to DHA ratio and the extra components.

ParameterRangeNote
Fish oil concentrate per serving1000 to 3000 mg across the reference labelsThe omega-3 concentration decides the weight needed
EPA per serving180 to 990 mg across the reference labelsSet together with DHA
DHA per serving120 to 660 mg across the reference labelsSet together with EPA
FormatSoftgelLiquid, gummy and capsule are separate projects
Add-onsOlive polyphenols, sesame lignans, vitamin D, astaxanthinEach add-on changes the fill and the oxidation stability

The pilot run confirms the fill weight and leak test, the fatty acid assay, the peroxide and anisidine values after storage and the taste.

Technical Status & Data Sources

ItemStatusDetails
Reference formulaNIH DSLDThe ingredients and amounts come from a labeled product in the NIH DSLD (Fish Oil Concentrate 2000 mg + EPA 700 mg + DHA 500 mg on the label of CF008121; example DSLD labels 60408, 60670, 60673). The label names the oil with a branded concentrate name; the oil form is set in the specification.
SpecificationSet in formulationFish oil concentrate with the omega-3 concentration, EPA and DHA content, oil form, peroxide value, anisidine value, heavy metal and microbial limits and methods fixed with the supplier. Unit size, fill weight and stability are set in formulation.
Data sourceNIH DSLDDSLD v9.4.0, downloaded 2026-01-10: 50,824 reference formulas merged from on-market labels with complete ingredient amounts. Counts show how labels are distributed.
Market reviewPer marketDose limits, labeling and claims are reviewed for each sales market before a finished product is developed.
ReferencesSources[1] Abdelhamid AS, Brown TJ, Brainard JS, et al. Omega-3 fatty acids for the primary and secondary prevention of cardiovascular disease. Cochrane Database Syst Rev. 2020;3:CD003177. DOI · PubMed<br>[2] Albert BB, Cameron-Smith D, Hofman PL, Cutfield WS. Oxidation of marine omega-3 supplements and human health. Biomed Res Int. 2013;2013:464921. DOI · PubMed

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