Pancreatin Tablets
»Pancreatin Tablets contain not less than 90.0percent 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 á61ñ— Tablets meet the requirements of the test for absence of Salmonellaspecies and Escherichia coli.
Assay for amylase activity (Starch digestive power)— Weigh and finely powder not fewer than 20Tablets,avoiding the production of heat during the process.Proceed as directed in the Assay for amylase activityunder Pancreatin,using as the assay preparation an accurately weighed portion of the powder,equivalent to 40mg 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 activityunder Pancreatin.
Assay test dilution— Proceed as directed for Assay test dilutionin the Assay for lipase activityunder 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 200mg of pancreatin.
Procedure and Calculation of potency—Proceed as directed in the Assay for lipase activityunder 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 activityunder Pancreatin.
Assay test dilution— Add an accurately weighed portion of the powder,prepared as directed in the Assay for amylase activity,equivalent to about 100mg of pancreatin,to 100.0mLof Buffer solution,and mix by shaking intermittently at room temperature for 25minutes.Dilute quantitatively with Buffer solutionto 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 activityunder Pancreatin.
Auxiliary Information— Staff Liaison:Larry N.Callahan,Ph.D.,Scientist
Expert Committee:(BNT)Biotechnology and Natural Therapeutics/Diagnostics
USP28–NF23Page 1462
Phone Number:1-301-816-8385