Pancrelipase Tablets

This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition

Issued and maintained by the United States Pharmacopeial Convention (USP)

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>> Pancrelipase Tablets contain an amount of Pancrelipase equivalent to not less than 90.0 percent and not more than 150.0 percent of the labeled lipase activity expressed in USP Units, the labeled activity being not less than 8000 USP Units per Tablet. They contain, in each Tablet, the pancrelipase equivalent of not less than 30,000 USP Units of Amylase activity, and not less than 30,000 USP Units of protease activity.

1 Packaging and storage

Preserve in tight containers, preferably with a desiccant, at a temperature not exceeding 25°.

2 Labeling

Label the Tablets to indicate the lipase activity in USP Units.

3 USP REFERENCE STANDARDS (11)

USP Bile Salts RS

USP Pancreatin Amylase and Protease RS

USP Pancreatin Lipase RS

4 MICROBIAL ENUMERATION TESTS (61) and TESTS FOR SPECIFIED MICROORGANISMS (62)

Tablets meet the requirements of the test for absence of Salmonella species and Escherichia coli.

5 DISINTEGRATION (701)

75 minutes.

6 LOSS ON DRYING (731)

Dry about 5 g, accurately weighed, of finely ground Tablets in vacuum at 60° for 4 hours: it loses not more than 5.0% of its weight.

7 Assay

Weigh and finely powder not less than 20 Tablets, avoiding the production of heat during the process, and proceed as directed for Assay for amylase activity, Assay for lipase activity, and Assay for protease activity under Pancrelipase.