What is a Pharmaceutical Grade Fish Oil?

pharmaceutical grade fish oil

The term ‘pharmaceutical grade fish oil’ is actually not a regulated term and depending on the manufacturer, it can have a number of different meanings or definitions:

  • The fish oils may have been made under GMP (Good Manufacturing Practices) where specific procedures are followed. This means that ALL criteria during each production step (including raw materials, facilities and equipment) are documented for consistency.

  • The product may have been manufactured in a government-approved facility following strict quality control standards and may have a ‘Drug Master File’ recognized by drug or health-related governing bodies.

  • The product qualifies to be used as a medicine.

In North American, many products will contain ultra-purified fish oils that provides high concentrations of EPA and DHA.

The most popular method for making ultra-purified fish oils is called molecular-distillation.

What’s a Molecular-Distilled Fish Oil?

pharmaceutical grade fish oil

Molecular distillation is a process used on manufacture and process fish oils that are highly purified with high levels of omega 3 fatty acids.

In the first step of processing, the raw fish oil’s fatty acids are chemically altered into ethyl esters.

The esters are placed in a vacuum where virtually all contaminants are separated and removed.

The fatty acids are then concentrated and purified through a distillation process.

The purified ethyl esters are then reconstituted into a highly-purified omega 3 fatty acid concentrates.

The end results is a highly-purified and extremely potent omega 3 concentrate.

However, not all pharmaceutical-grade fish oils are made through molecular distillation.

How to Spot a Pharmaceutical-Grade Fish Oil?

pharmaceutical grade fish oil capsules

Only a Certificate of Analysis is the only way to tell if you have a pharmaceutical grade fish oil.

Most labs that analyze and certify fish oils will follow certain set of criteria or guidelines:

  • The fish oils must contain an internationally accepted minimum amount of EPA and DHA.

  • The amount of PCB, Dioxin, Furan and Mercury must be less than a specified percentage.

  • The product must be made according to ‘pharmaceutical standards’ in a facility certified in ‘Good Manufacturing Practices (cGMP) approved for manufacturing pharmaceutical goods.

Examples of Pharmaceutical-Graded Fish Oils

pharmaceutical grade fish oil capsules

Dr. Tobias NSF-Certified Omega 3 Fish Oil is purified through molecular-distillation and third-party tested to provide highly purified levels of the omega 3 concentrates EPA and DHA.

Another highly-purified product is Ascenta Health NutraSea. Each bottle comes with its own batch number on the ingredient label. You can enter this batch number on the company website and it will show you the actual test results for that batch of fish oil in your bottle.

Using a pharmaceutical grade fish oil may help you avoid some of the common side effects associated with lower-quality oils, such as upset stomach, gas and fish burps.

While some products may cost slightly more than lower-grade fish oils, you can be assured that they’ve been certified and tested to meet certain criteria for purity.

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