Fish Oil, EPA & DHA

Fish oil reference formula with EPA and DHA at an example 1,000 mg of oil per serving, developed as a softgel or a liquid.

Fish Oil, EPA & DHA is a reference formula for brands building a marine omega-3 product on a fish oil base, with the EPA and DHA amounts declared as parts of that oil. The example serving carries 1,000 mg of fish oil with 180 mg of EPA and 120 mg of DHA, which is 300 mg of EPA and DHA or 30% of the oil by weight, and the brand sets the final amounts for its market.

Softgel is the lead format because a one-gram oil serving fits a single softgel and the sealed shell keeps air away from the oil. A liquid oil in a bottle carries the same oil with a flavor and antioxidant system. The development work centers on the oil grade and concentration, the oxidative quality of the oil and the shell or bottle system around it.

Ingredient Composition

IngredientPer ServingRaw Material FormAlternative Form (same amount of active)
Fish Oil1000 mg (example amount)Refined marine fish oil as triglycerides, stabilized with mixed tocopherols; specification 1,000 mg oil per servingConcentrated fish oil at a smaller oil weight that keeps the same EPA and DHA content
EPA180 mg (example amount)Contained in the fish oil, declared as eicosapentaenoic acidHigher-EPA concentrate with the oil weight adjusted
DHA120 mg (example amount)Contained in the fish oil, declared as docosahexaenoic acidHigher-DHA concentrate with the oil weight adjusted

EPA and DHA are stated as mg of the fatty acids contained in the oil, not as additions to it. The weights of EPA and DHA are declared on a free fatty acid basis or a triglyceride basis, and the basis is written into the specification with the supplier. The oil input is the declared oil weight; a concentrate is calculated back to the same EPA and DHA content from its assay.

Intended Benefits & Formula Rationale

This formula is designed for products positioned around daily EPA and DHA intake and heart and circulatory nutrition. Fish oil is included as the single oil base so that the concentration, the stabilizer and the shell can be set around one ingredient.

Intended Benefit DirectionKey IngredientsFormulation Rationale
Daily EPA and DHA intakeFish Oil, EPA, DHAIncluded as long-chain omega-3 fats from oily fish, the group that a Cochrane review of 86 trials examined at doses from 0.5 g to more than 5 g a day [1]. Evidence: Referenced
Triglyceride nutritionEPA, DHAThe same review found that increasing long-chain omega-3 intake reduced serum triglycerides by about 15% in a dose-dependent way, with high-certainty evidence [1]. Evidence: Referenced
Cardiovascular outcomesEPA, DHAThe review found little or no effect on all-cause mortality and cardiovascular events, and a slight reduction in coronary heart disease mortality and events with low-certainty evidence [1]. Evidence: Mixed

The example amounts are a starting point for the brand, since the reference amounts spread across many oil weights and concentrations. Oxidation of marine oils may affect the benefit and harm reported in trials, and the oxidative state of an oil can be set from peroxide and anisidine values [2].

Available Formats

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

FormatUnitPer ServingPack SizeOther Ingredients (typical)Suitability
Softgel1 softgel1000 mg oil (EPA 180 mg, DHA 120 mg)60 or 120 softgelsGelatin or plant-based shell, glycerin, mixed tocopherols, flavorLead format; oil sealed from air
Liquid5 mL1000 mg oil (EPA 180 mg, DHA 120 mg)150 or 300 mL bottleMixed tocopherols, natural flavor, rosemary extractBottled oil with a flavor and antioxidant system

Raw Material Input & Fill (Design Estimate)

Design estimates. The oil input is the declared oil weight at an assumed 100% assay with mixed tocopherols carried inside the oil weight, so 1000 mg of oil per serving is used as the fill for a softgel.

FormatRaw Material Input per UnitDesign FillBalance for ExcipientsVerification Before Scale-Up
Softgel1000 mg oil1000 mg fill in a size 20 oblong shellShell weight is separate from the fillShell integrity, leak test, peroxide and anisidine values, content assay of EPA and DHA
Liquid1000 mg oil per 5 mL5 mL (about 4.6 g at an assumed oil density of 0.92 g/mL)Flavor and antioxidant systemTaste, peroxide and anisidine values through shelf life, content assay of EPA and DHA

Hard capsule and gummy versions are separate projects, because a liquid oil needs a sealed shell or a different delivery system.

Formulation Considerations

EPA and DHA content versus oil weight. At 300 mg of EPA and DHA in 1000 mg of oil, the oil is 30% EPA and DHA. A higher-concentration oil reaches the same EPA and DHA content with fewer or smaller softgels, and the oil grade is fixed together with the unit size.
Oxidation control. Marine oils are highly prone to oxidation, and trials seldom report the oxidative state of the oil [2]. Antioxidant level, nitrogen flushing during filling, pack barrier and peroxide and anisidine values at release and through shelf life are set in the specification.
Shell compatibility. Gelatin shells suit a standard softgel, and plant-based shells need their own seal and compatibility checks with the oil. Shell choice follows the target market and its dietary requirements.
Evidence and claims. The Cochrane review found little or no effect of increasing long-chain omega-3 intake on mortality and cardiovascular events [1], so claims on a finished product are reviewed for each sales market before a product is developed.

Customization Options

Brands adjust the oil weight, the EPA and DHA concentration, the format and the add-ons.

ParameterRangeNote
Oil per serving1000 or 2000 mgEPA and DHA content scales with the oil weight
EPA and DHA concentration18:12 or 30:20 mg per gram of oilOption for the brand; concentrate changes oil cost and stability
FormatSoftgel or liquidHard capsule and gummy are separate projects
Flavor and shellLemon or orange; gelatin or plant-basedSets the odor profile and the dietary label
Add-onsVitamin E, vitamin DFat-soluble add-ons are dissolved in the oil and change the specification

The pilot run confirms softgel seal integrity, peroxide and anisidine values of the first fills, odor and taste in the liquid, and the content assay of EPA and DHA against the labeled amounts.

Flavor Options

FormatSuggested FlavorsWhy
SoftgelLemon (in the fill)A light citrus note limits fishy aftertaste on burping
LiquidLemon, orangeCitrus profiles cover the marine odor of the oil

Technical Status & Data Sources

ItemStatusDetails
Reference formulaNIH DSLDThe ingredient and amount come from a labeled product in the NIH DSLD (Fish Oil 1000 mg + EPA 180 mg + DHA 120 mg on the label of CF001917; example DSLD labels 11993, 65628, 187565). The label names fish oil with EPA and DHA; the triglyceride form is set as the form.
SpecificationSet in formulationRefined fish oil, 1,000 mg per serving with EPA 180 mg and DHA 120 mg; fatty acid basis, peroxide value, anisidine value and contaminant limits and method are 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(3):CD003177. DOI · PubMed<br>[2] Albert BB, Cameron-Smith D, Hofman PL, et al. Oxidation of marine omega-3 supplements and human health. Biomed Res Int. 2013;2013:464921. DOI · PubMed

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