DEFINITION

Pancreatin is a substance containing enzymes, principally amylase, lipase, and protease, obtained from the pancreas of the hog, Sus scrofa Linné var. domesticus Gray (Fam. Suidae) or of the ox, Bos taurus Linné (Fam. Bovidae). Pancreatin contains, in each mg, NLT 25 USP Units of amylase activity, NLT 2.0 USP Units of lipase activity, and NLT 25 USP Units of protease activity. Pancreatin of a higher digestive power may be labeled as a whole-number multiple of the three minimum activities or may be diluted by admixture with lactose, or with sucrose containing NMT 3.25% of starch, or with pancreatin of lower digestive power. One USP Unit of lipase activity is contained in the amount of pancreatin that liberates 1.0 µEq of acid/min at a pH of 9.0 and 37° under the conditions of the Assay for Lipase Activity. One USP Unit of protease activity is contained in the amount of pancreatin that, under the conditions of the Assay for Protease Activity, hydrolyzes casein at an initial rate such that there is liberated per minute an amount of peptides not precipitated by trichloroacetic acid that gives the same absorbance at 280 nm as 15 nmol of tyrosine.