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Cod Liver Oil Capsules
» Cod Liver Oil Capsules contain not less than 95.0 percent and not more than 105.0 percent of the labeled amount of Cod Liver Oil. The oil contained in Cod Liver Oil Capsules conforms to the Definition for Cod Liver Oil.
Packaging and storage— Preserve in tight containers at room temperature. Protect from light.
Labeling— Vitamin A potency and vitamin D potency, when designated on the label, may be expressed in USP Units per g of oil. The potency may also be expressed in metric units, on the basis that 1 USP Vitamin A Unit = 0.3 µg of all-trans retinol and 40 USP Vitamin D Units = 1 µg. Label them to emphasize the need to avoid freezing or exposure to excessive humidity or to a temperature above 40. Where the content of docosahexaenoic acid and eicosapentaenoic acid is claimed, state the amount in mg per capsule on the label.
Identification—
Vitamin A— The oil contained in the Capsule responds to the test for Identification for vitamin A under Cod Liver Oil.
Fatty acid profile— Proceed as directed in Identification, Fatty acid profile under Cod Liver Oil. The oil contained in the Capsules meets the requirements.
Weight variation 2091: meets the requirements.
Disintegration and dissolution 2040—
RUPTURE TEST—
Medium: water; 500 mL.
Apparatus: Use Apparatus 2 as described under Dissolution 711 operating at 50 rpm.
Times: 15 minutes; 30 minutes.
Procedure— Place 1 Capsule in each vessel, and allow the Capsule to sink to the bottom of the vessel before starting rotation of the blade. Observe the Capsules, and record the time taken for each capsule shell to rupture.
Tolerances— The requirements are met if all of the Capsules tested rupture in not more than 15 minutes. If 1 or 2 of the Capsules rupture in more than 15 minutes, but not more than 30 minutes, repeat the test on 12 additional Capsules. Not more than 2 of the total of 18 Capsules tested rupture in more than 15, but not more than 30 minutes.
Content of cod liver 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 isooctane. Discard the washings, and allow the empty capsules to dry in a current of dry air until the isooctane is completely evaporated. Weigh the empty capsules in the original tared weighing bottle, and calculate the average net weight per capsule.
Residual solvents 467: meet the requirements.
(Official January 1, 2007)
Other requirements— The contents of the Capsules meet the requirements of the tests for Specific gravity, Nondestearinated cod liver oil, Unsaponifiable matter, Acid value, Iodine value, Saponifiable value, Assay for vitamin A, and Assay for vitamin D under Cod Liver Oil.
Auxiliary Information— Staff Liaison : Lawrence Evans, III, Ph.D., Scientist
Expert Committee : (DSN05) Dietary Supplements - Non-Botanicals
USP29–NF24 Page 2312
Pharmacopeial Forum : Volume No. 29(3) Page 623
Phone Number : 1-301-816-8389