Pancreatin Tablets

This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition

Issued and maintained by the United States Pharmacopeial Convention (USP)

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>> Pancreatin Tablets contain not less than 90.0 percent of the labeled amount of pancreatin.

1 Packaging and storage

Preserve in tight containers, preferably at a temperature not exceeding 30°.

2 Labeling

Label the Tablets to indicate minimum pancreatin fat digestive power; i.e., single strength, double strength, triple strength.

3 USP REFERENCE STANDARDS (11)

USP Bile Salts RS

USP Pancreatin Amylase and Protease RS

USP Pancreatin Lipase RS

4 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.

5 DISINTEGRATION (701)

60 minutes.

6 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.)

7 Assay for lipase activity (Fat digestive power)

7.1 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.

7.2 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.

7.3 Procedure and Calculation of potency

Proceed as directed in the Assay for lipase activity under Pancreatin.

8 Assay for protease activity (Casein digestive power)

8.1 Casein substrate, Buffer solution, Trichloroacetic acid solution, Filter paper and Standard test dilution

Prepare as directed in the Assay for protease activity under Pancreatin.

8.2 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.

8.3 Procedure and Calculation of potency

Proceed as directed in the Assay for protease activity under Pancreatin.