U.S. PHARMACOPEIA

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Pancrelipase Tablets
» 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.
Packaging and storage— Preserve in tight containers, preferably with a desiccant, at a temperature not exceeding 25.
Labeling— Label the Tablets to indicate the lipase activity in USP Units.
Microbial limits 61— Tablets meet the requirements of the test for absence of Salmonella species and Escherichia coli.
Disintegration 701: 75 minutes.
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.
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.
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