U.S. PHARMACOPEIA

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Pancreatin Tablets
» Pancreatin Tablets contain not less than 90.0 percent of the labeled amount of pancreatin.
Packaging and storage— Preserve in tight containers, preferably at a temperature not exceeding 30.
Labeling— Label the Tablets to indicate minimum pancreatin fat digestive power; i.e., single strength, double strength, triple strength.
Microbial limits 61— Tablets meet the requirements of the test for absence of Salmonella species and Escherichia coli.
Disintegration 701: 60 minutes.
Assay for amylase activity (Starch digestive power)— Weigh and finely powder not fewer than 20 Tablets, avoiding the production of heat during the process. Proceed as directed in the Assay for amylase activity under Pancreatin, using as the assay preparation an accurately weighed portion of the powder, equivalent to 40 mg of pancreatin. (Use an inversely proportionate amount of the powder if the Tablets are labeled to contain a whole-number multiple of the minimum requirement for pancreatin digestive activity.)
Assay for lipase activity (Fat digestive power)—
Acacia solution, Olive oil substrate, Buffer solution, Bile salts solution, and Standard test dilution— Prepare as directed in the Assay for lipase activity under Pancreatin.
Assay test dilution— Proceed as directed for Assay test dilution in the Assay for lipase activity under Pancreatin, using as the assay preparation an accurately weighed portion of the powder, prepared as directed in the Assay for amylase activity, equivalent to about 200 mg of pancreatin.
Procedure and Calculation of potency—Proceed as directed in the Assay for lipase activity under Pancreatin.
Assay for protease activity (Casein digestive power)—
Casein substrate , Buffer solution, Trichloroacetic acid solution, Filter paper, and Standard test dilution—Prepare as directed in the Assay for protease activity under Pancreatin.
Assay test dilution— Add an accurately weighed portion of the powder, prepared as directed in the Assay for amylase activity, equivalent to about 100 mg of pancreatin, to 100.0 mL of Buffer solution, and mix by shaking intermittently at room temperature for 25 minutes. Dilute quantitatively with Buffer solution to obtain a dilution that corresponds in activity to the Standard test dilution.
Procedure and Calculation of potency—Proceed as directed in the Assay for protease activity under Pancreatin.
Auxiliary Information— Staff Liaison : Larry N. Callahan, Ph.D., Scientist
Expert Committee : (BBPP05) Biologics and Biotechnology - Proteins and Polysaccharides
USP29–NF24 Page 1631
Phone Number : 1-301-816-8385