Pancrelipase Capsules

» 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.

Packaging and storage— Preserve in tight containers, preferably with a desiccant, at a temperature not exceeding 25

Labeling— Label the Capsules to indicate lipase activity in USP Units.

USP Reference standards

—

USP Bile Salts RS

USP Pancreatin Amylase and Protease RS

USP Pancreatin Lipase RS

Microbial enumeration tests

and Tests for specified microorganisms

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

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.

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.

Auxiliary Information— Please check for your question in the FAQs before contacting USP.

Topic/Question	Contact	Expert Committee
Monograph	Fouad Atouf, Ph.D. Senior Scientific Liaison 1-301-816-8365	(BIO12010) Monographs - Biologics and Biotechnology 1
Reference Standards	RS Technical Services 1-301-816-8129 rstech@usp.org
61	Radhakrishna S Tirumalai, Ph.D. Principal Scientific Liaison 1-301-816-8339	(GCM2010) General Chapters - Microbiology
62	Radhakrishna S Tirumalai, Ph.D. Principal Scientific Liaison 1-301-816-8339	(GCM2010) General Chapters - Microbiology

USP35–NF30 Page 4206