Method to quantify and measure excess colipase in a pancreatin active pharmaceutical ingredient

1. A method of measuring an amount of colipase in a pancreatin active pharmaceutical ingredient (API) sample comprising:

i) incubating a pancreatin API sample for a time sufficient to prepare a sample free of lipase activity and containing an unknown amount of colipase;

ii) adding the incubated pancreatin API sample to a substrate comprising glycerol tributyrin (GTB) and sodium taurodeoxycholate hydrate (TDC) to afford a sample solution;

iii) titrating the sample solution with a solution of sodium hydroxide at a constant temperature to maintain a certain pH for a period of time;

iv) generating a titration value from step iii) in ml/minute;

v) repeat steps ii)-iii) for a standard lipase sample containing a known amount of lipase;

vi) generating a titration value from step v) in ml/minute; and

vii) calculating colipase content of the pancreatin API sample as a difference between the titration value from step vi) and the titration value from step iv).

2. A method according to claim 1 wherein the pancreatin API sample is incubated for 30 minutes.

3. A method according to claim 1 wherein each adding and titrating step, collectively, is performed for five minutes.

4. A method according to claim 3 wherein the temperature is maintained at 37° C.

5. A method according to claim 3 wherein the pH is maintained at 7.5.