Action and use
Enzyme; treatment of pancreatic exocrine deficiency.
DEFINITION
Pancreatin Granules contain Pancreatin and may also contain suitable gastro-resistant substances.
The granules comply with the requirements stated under Granules and with the following requirements.
Content of pancreatin
Not less than 90.0% of the stated minimum number of Units of free protease activity, of lipase activity and of amylase activity.
IDENTIFICATION
A. The granules demonstrate free protease activity in the Assay for Free protease activity.
B. Triturate a quantity of powdered granules containing 2.5 g of Pancreatin with 100 mL of water and filter. Adjust 10 mL of the liquid to pH 8.0 by the addition of 1M sodium hydroxide using cresol red solution as indicator. Divide the resulting solution into two equal portions. Boil one portion [solution (1)] and leave the other untreated [solution (2)]. Dissolve 0.1 g of soluble starch in 100 mL of boiling water, boil for 2 minutes, cool and dilute to 150 mL with water. Add solution (1) to half the starch mucilage and solution (2) to the remainder and maintain the mixtures at 38° to 40° for 5 minutes. To 1 mL of each mixture add 10 mL of iodinated potassium iodide solution. The liquid containing solution (2) retains the colour of the solution of iodine and the liquid containing solution (1) acquires an intense blue colour.
ASSAY
Carry out the Assay of pancreatin, Appendix XIV I, using in the determination of each activity a quantity of the powdered granules estimated to contain the number of Units specified in the method.
STORAGE
Pancreatin Granules should be stored at a temperature not exceeding 15°, unless otherwise justified and authorised.
LABELLING
The label states (1) the minimum number of Units of free protease activity, of lipase activity and of amylase activity per g; (2) where applicable, that the granules contain gastro-resistant substances.
