Printed on: Fri Jan 05 2024, 09:53:01 PM(EST) Status: Currently Official on 06-Jan-2024 DocId: GUID-48B1FA91-F951-46AB-9E83-D05E2C22F8A9_1_en-US
Printed by: USP NF Official Date: Official Prior to 2013 Document Type: USP @2024 USPC
Do Not Distribute DOI Ref: v7qw6 DOI: https://doi.org/10.31003/USPNF_M60290_01_01
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Assay for lipase activity (Fat digestive power)—
Pancreatin Tablets Acacia solution, Olive oil substrate, Buffer solution, Bile salts
solution,and Standard test dilution—Prepare as directed in the
» Pancreatin Tablets contain not less than 90.0 Assay for lipase activity under Pancreatin.
Assay test dilution—Proceed as directed for Assay test
percent of the labeled amount of pancreatin. dilution in the Assay for lipase activity under Pancreatin, using
as the assay preparation an accurately weighed portion of the
Packaging and storage—Preserve in tight containers, powder, prepared as directed in the Assay for amylase activity,
preferably at a temperature not exceeding 30°. equivalent to about 200 mg of pancreatin.
Labeling—Label the Tablets to indicate minimum pancreatin Procedure and Calculation of potency—Proceed as directed
fat digestive power; i.e., single strength, double strength, in the Assay for lipase activity under Pancreatin.
triple strength.
USP Reference standards á11ñ— Assay for protease activity (Casein digestive power)—
USP Bile Salts RS Casein substrate, Buffer solution, Trichloroacetic acid solution,
USP Pancreatin Amylase and Protease RS Filter paper and Standard test dilution—Prepare as directed in
USP Pancreatin Lipase RS the Assay for protease activity under Pancreatin.
Microbial enumeration tests á61ñ and Tests for specified Assay test dilution—Add an accurately weighed portion of
microorganisms á62ñ—Tablets meet the requirements of the the powder, prepared as directed in the Assay for amylase
test for absence of Salmonella species and Escherichia coli. activity, equivalent to about 100 mg of pancreatin, to
Disintegration á701ñ: 60 minutes. 100.0 mL of Buffer solution, and mix by shaking intermittently
Assay for amylase activity (Starch digestive power)— at room temperature for 25 minutes. Dilute quantitatively with
Weigh and finely powder not fewer than 20 Tablets, avoiding Buffer solution to obtain a dilution that corresponds in activity
the production of heat during the process. Proceed as directed to the Standard test dilution.
al
in the Assay for amylase activity under Pancreatin, using as the Procedure and Calculation of potency—Proceed as directed
assay preparation an accurately weighed portion of the in the Assay for protease activity under Pancreatin.
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 ci
requirement for pancreatin digestive activity.)
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