USP’s New Krill Oil Monograph. How it Will Help the Industry

USP-Pharmacopeia-copyUSP Publishes Krill Oil Monograph

The Food Chemicals Codex of the U.S. Pharmacopeia has released a standard for krill oil. While GOED members involved in the krill business are still analyzing the individual parameters set forth in the new standard, some specifics of the monograph include:

  • DHA and EPA Acceptance criteria: EPA not less than 10.0%, DHA not less than 5.0%.
  • Inorganic Impurities: arsenic, lead, mercury
  • Specific Tests: astaxanthin esterification, content of astaxanthin, peroxide value, phospholipids
  • Other Requirements include one for labeling:“Label to indicate the content of both Eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) in mg/g (%). Indicate the presence of any other oil(s) used to standardize the EPA and DHA content. Indicate the type and level of solvents present from extraction.”

Summarized Acceptance Criteria:
(NLT = not less than; NMT = not more than):
EPA: NLT 10.0%
DHA: NLT 5.0%
Arsenic: NMT 0.1 mg/kg, as inorganic arsenic
Lead: NMT 0.1 mg/kg
Mercury: NMT 0.1 mg/kg

Content of Astaxanthin: NLT 100 mcg/g
Peroxide Value: Less than 5 mEq/kg
Total phospholipids: 28%–52% (w/w)
Phosphatidylcholine content: 60%–90% of the Total phospholipids content, by weight, is phosphatidylcholine.

The monograph is only available on a subscription basis and is published in the FCC Eighth Edition, Third Supplement.

The Canadian made some progress on this few years ago.  Their monograph was intended to serve as a guide to industry for the preparation of Product License Applications (PLAs) and labels for natural health product market authorization. It was not intended to be a comprehensive review of the medicinal ingredient. More on this seen at – Canada-Mono_Krill-Oil

See more at –

See more at –’s-new-krill-oil-monograph-help-industry-5-18967

Dimitri Sclabos
Dimitri Sclabos

Founder and Co-owner