Pancrelipase Capsules

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 Capsules 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 Capsule. They contain, in each Capsule, 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 Capsules to indicate 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)

Capsules meet the requirements of the tests for absence of Salmonella species and Escherichia coli.

5 LOSS ON DRYING (731)

Dry the contents of 10 Capsules in vacuum at 60° for 4 hours: it loses not more than 5.0% of its weight.

6 Assay

Weigh the contents of not less than 10 Capsules, and determine the average weight per capsule. Mix the combined contents, and proceed as directed for Assay for amylase activity, Assay for lipase activity, and Assay for protease activity under Pancrelipase.