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.

USP Reference standards

—

USP Bile Salts RS

USP Pancreatin Amylase and Protease RS

USP Pancreatin Lipase RS

Microbial enumeration tests

and Tests for specified microorganisms

— 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— Please check for your question in the FAQs before contacting USP.

Topic/Question	Contact	Expert Committee
Monograph	Fouad Atouf, Ph.D. Senior Scientific Liaison 1-301-816-8365	(BIO12010) Monographs - Biologics and Biotechnology 1
Reference Standards	RS Technical Services 1-301-816-8129 rstech@usp.org
61	Radhakrishna S Tirumalai, Ph.D. Principal Scientific Liaison 1-301-816-8339	(GCM2010) General Chapters - Microbiology
62	Radhakrishna S Tirumalai, Ph.D. Principal Scientific Liaison 1-301-816-8339	(GCM2010) General Chapters - Microbiology
701	Margareth R.C. Marques, Ph.D. Senior Scientific Liaison 1-301-816-8106	(GCDF2010) General Chapters - Dosage Forms

USP35–NF30 Page 4204