Nutraceutical Dietary Supplement

Identification

Country of Origin

Norway

Ingredient Name

Omega-3 Triglyceride Fish oil

Raw Material Origin

Marine Origin,

Natural Origin

Blend

false

Ingredient Composition

Omega-3 Triglyceride Fish oil, Tocopherols

Single Ingredient

true

Categories

Technologies → Pharmaceuticals & Nutraceuticals → Product Families → Nutraceuticals & Supplements → Fatty Acids & Specialty Lipids

Markets → Healthcare & Pharma → Applications → Drug Delivery & Care Solutions → Oral

Applications

Dosage Form

Capsules,

Soft Gels

Applications & Uses

Recommended Applications

Dietary supplements: Nutraceutical Dietary Supplement is intended for use in dietary supplements such as in soft gel capsules.

Benefits & Claims

Labeling Claims

Natural,

Naturally Derived,

Sustainable

Functions

Pharma & Nutraceuticals Functions

Supplement

Function

Supplement

Identification & Functionality

Composition

• Ingredients in descending order of weight: Fish oil concentrate, tocopherol-rich extract* (E 306).
• Note : * mainly derived from soybean (from identity preserved, not genetically modified origin)

Structural Formula

Eicosapentaenoic Acid EPA

Docosahexaenoic Acid DHA

Packaging & Availability

Packaging Type

Drums

Packaging Information

190 kg steel drum

Properties

Physical Form

Liquid

Solubility

Practically insoluble in water, very soluble in acetone and heptane, slightly soluble in anhydrous ethanol.

Regulatory & Compliance

Certifications & Compliance

European Pharmacopeia (Ph. Eur.),

Hazard Analysis Critical Control Point (HACCP),

United States Pharmacopeia (USP),

cGMP,

FSSC 22000

Regulatory Information

Produced under cGMP and HACCP principles.

Monographs and Regulations 

Nutraceutical Dietary Supplement meets the require- ments for an omega-3 fatty acid source in most  countries. The product complies with the USP monograph for Omega-3 acid triglycerides and  the Ph. Eur. monograph on Omega-3-acid tri- glycerides (1352). Further, the product conforms  to the voluntary GOED monograph in the current version. Fish oil concentrates are accepted for use in dietary supplements in most countries. However, specific regulations on the product and its ingredients in the respective countries and for its intended use have to be observed.

Storage & Handling

Storage Information

• Stored in its unopened original packaging at ambient conditions (0 – 25 °C), the product is stable for at least 36 months.
• The product is sensitive to oxygen, light and heat. It should therefore be stored in the tightly sealed, lightproof packaging in a cool place. Once opened, it is recommended to use the remaining contents as quickly as possible.