Pancrelipase Delayed-Release Capsules
»Pancrelipase Delayed-Release Capsules contain an amount of Pancrelipase equivalent to not less than 90.0percent and not more than 165.0percent of the labeled lipase.It contains not less than 90.0percent of the labeled activities of amylase and protease expressed in the respective USP Units.
Packaging and storage— Preserve in tight containers at controlled room temperature.
Labeling— Label the Capsules to indicate lipase,amylase,and protease activities in USP Units.The label also indicates that the Capsule contents are enteric-coated.
Microbial limits á61ñ— Capsules meet the requirements of the tests for absence of Salmonellaspecies and Escherichia coli.
Dissolution á711ñ—
PART1 —
Medium: simulated gastric fluid TS,without enzyme;800mL.
Apparatus 1: 100rpm.
Time: 60minutes.
PART2 —
pH6.0phosphate buffer— Dissolve 8g of sodium chloride and 36.8g of monobasic potassium phosphate in 4000mLof water.Adjust with 2Nsodium hydroxide to a pHof 6.0±0.1.
Medium: pH6.0phosphate buffer;800mL.
Apparatus 2: 100rpm.
Time: 30minutes.
Standard solution— Proceed as directed under Standard test dilutionin the Assay for lipase activityunder Pancrelipase,except to use the Dissolution Mediumin place of cold water.
Test solution— Empty the contents of 10Capsules,and transfer an accurately weighed portion of the contents,equivalent to the concentration of USP Units of lipase activity per mLin the Standard solution(between 8and 16Units per mL),to Apparatus 1.
Procedure— Proceed according to the conditions for Part 1.After 1hour,remove the baskets,and allow the excess Dissolution Mediumto drain.Transfer the contents of each basket to the dissolution vessels in Part 2with the aid of a few mLof Dissolution Medium.Proceed according to the conditions for Part 2.After 30minutes,remove a 10-mLportion of the solution under test,transfer to a test tube,and cool to 4.Proceed as directed in the Assay for lipase activityunder Pancrelipase.
Tolerances— Not less than 75%(Q)of the labeled USP Units of lipase activity per Capsule is dissolved.
Loss on drying á731ñ— Dry the contents of 10Capsules in vacuum at 60for 4hours:the test specimen loses not more than 5.0%of its weight.
Assay— Weigh the contents of not less than 10Capsules,and determine the average weight per Capsule.Grind the contents,mix the combined contents,and proceed as directed in the Assay for lipase activity,the Assay for amylase activity,and the Assay for protease activityunder Pancrelipase.
Auxiliary Information— Staff Liaison:Larry N.Callahan,Ph.D.,Scientist
Expert Committee:(BNT)Biotechnology and Natural Therapeutics/Diagnostics
USP28–NF23Page 1464
Phone Number:1-301-816-8385