U.S. PHARMACOPEIA

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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.
Microbial limits 61— 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— Staff Liaison : Larry N. Callahan, Ph.D., Scientist
Expert Committee : (BBPP05) Biologics and Biotechnology - Proteins and Polysaccharides
USP29–NF24 Page 1633
Phone Number : 1-301-816-8385