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 enumeration tests 61 and Tests for specified microorganisms 62— 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— Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Monograph Larry N. Callahan, Ph.D.
Senior Scientist
1-301-816-8385		 (BBPP05) Biologics and Biotechnology - Proteins and Polysaccharides
Reference Standards Lili Wang, Technical Services Scientist
1-301-816-8129
RSTech@usp.org
61 Radhakrishna S Tirumalai, Ph.D.
Senior Scientist
1-301-816-8339		 (MSA05) Microbiology and Sterility Assurance
62 Radhakrishna S Tirumalai, Ph.D.
Senior Scientist
1-301-816-8339		 (MSA05) Microbiology and Sterility Assurance
701 Margareth R.C. Marques, Ph.D.
Senior Scientist
1-301-816-8106		 (BPC05) Biopharmaceutics05
USP32–NF27 Page 3198