Pancrelipase Tablets
»Pancrelipase Tablets contain an amount of Pancrelipase equivalent to not less than 90.0percent and not more than 150.0percent of the labeled lipase activity expressed in USP Units,the labeled activity being not less than 8000USP Units per Tablet.They contain,in each Tablet,the pancrelipase equivalent of not less than 30,000USP Units of amylase activity,and not less than 30,000USP 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 á61ñ— Tablets meet the requirements of the test for absence of Salmonellaspecies and Escherichia coli.
Loss on drying á731ñ— Dry about 5g,accurately weighed,of finely ground Tablets in vacuum at 60for 4hours:it loses not more than 5.0%of its weight.
Assay— Weigh and finely powder not less than 20Tablets,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 activityunder Pancrelipase.
Auxiliary Information— Staff Liaison:Larry N.Callahan,Ph.D.,Scientist
Expert Committee:(BNT)Biotechnology and Natural Therapeutics/Diagnostics
USP28–NF23Page 1464
Phone Number:1-301-816-8385