Part 1 —

Medium: simulated gastric fluid TS, without enzyme; 800 mL.

Apparatus 1: 100 rpm.

Time: 60 minutes.

Part 2 —

pH 6.0 phosphate buffer— Dissolve 8 g of sodium chloride and 36.8 g of monobasic potassium phosphate in 4000 mL of water. Adjust with 2 N sodium hydroxide to a pH of 6.0 ± 0.1.

Medium: pH 6.0 phosphate buffer; 800 mL.

Apparatus 2: 100 rpm.

Time: 30 minutes.

Standard solution— Proceed as directed under Standard test dilution in the Assay for lipase activity under Pancrelipase, except to use the Dissolution Medium in place of cold water.

Test solution— Empty the contents of 10 Capsules, and transfer an accurately weighed portion of the contents, equivalent to the concentration of USP Units of lipase activity per mL in the Standard solution (between 8 and 16 Units per mL), to Apparatus 1.

Procedure— Proceed according to the conditions for Part 1. After 1 hour, remove the baskets, and allow the excess Dissolution Medium to drain. Transfer the contents of each basket to the dissolution vessels in Part 2 with the aid of a few mL of Dissolution Medium. Proceed according to the conditions for Part 2. After 30 minutes, remove a 10-mL portion of the solution under test, transfer to a test tube, and cool to 4. Proceed as directed in the Assay for lipase activity under Pancrelipase.

Tolerances— Not less than 75% (Q) of the labeled USP Units of lipase activity per Capsule is dissolved.