Fish Oil Containing Omega-3 Acids Capsules
» Fish Oil Containing Omega-3 Acids Capsules contain not less than 95.0 percent and not more than 105.0 percent of the labeled amount of Fish Oil Containing Omega-3 Acids. The oil contained in Fish Oil Containing Omega-3 Acids Capsules conforms to the definition for Fish Oil Containing Omega-3 Acids.
Packaging and storage Preserve in tight containers, and store at room temperature. Protect from light.
Labeling The label states the amount of docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA) in mg per Capsule.
USP Reference standards 11
USP Docosahexaenoic Acid Ethyl Ester RS.
USP Eicosapentaenoic Acid Ethyl Ester RS.
USP Fish Oil RS.
USP Methyl Tricosanoate RS.
Identification Proceed as directed for Identification under Fish Oil Containing Omega-3 Acids. The oil contained in the Capsules meets the requirements.
Weight variation 2091: meet the requirements.
Disintegration and dissolution 2040 Proceed as directed in the chapter under Rupture Test for Soft Gelatin Capsules: meet the requirements.
Content of fish oil Accurately weigh not fewer than 10 Capsules in a tared weighing bottle. With a sharp blade, or by other appropriate means, carefully open the Capsules, without loss of shell material, and transfer the combined Capsule contents to a 100-mL beaker. Remove any adhering substance from the emptied Capsules by washing with several small portions of 2,2,4-trimethylpentane. Discard the washings, and allow the empty Capsules to dry in a current of dry air until the 2,2,4-trimethylpentane is completely evaporated. Weigh the empty Capsules in the original tared weighing bottle, and calculate the average net weight per Capsule.
Content of EPA and DHA and Content of total omega-3 acids Proceed as directed for in the Content of EPA and DHA and Content of total omega-3 acids under Fish Oil Containing Omega-3 Acids.
Other requirements The contents of the Capsules meet the requirements of the tests for Acid value, Anisidine value, Peroxide value, Total oxidation value, Unsaponifiable matter, Stearin, Absorbance, Limit of arsenic, Limit of lead, Limit of cadmium, Limit of mercury, and Limit of dioxins, furans, and polychlorinated biphenyls under Fish Oil Containing Omega-3 Acids.
Auxiliary Information Please check for your question in the FAQs before contacting USP.Chromatographic Column
USP32NF27 Page 1009Pharmacopeial Forum: Volume No. 33(3) Page 477
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.