» 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.
USP Reference standards 11
USP Bile Salts RS.
USP Pancreatin Amylase and Protease RS.
USP Pancreatin Lipase RS.
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.
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USP32NF27 Page 3198