Stability Indicating Methods

A Stability Indicating Method (SIM) is defined as a validated analytical procedure that accurately and precisely measures active ingredients (drug substance or drug product) free from process impurities, excipients and degradation products. SIMs must be validated for the specific formulation being tested. The SIM is used to perform the assay (test) and ultimately extend the beyond use date.

This session will illustrate how SIM are performed and include specific examples for quantitative assays. A comparison of stability indicating methods and release methods will be presented for sterile and non-sterile products. Participants will gather an understanding of the basic process for developing and validating SIM.

Learning Objectives:

At the conclusion of the program, the participants should be able to:
(1) Define a stability indicating method.
(2) Explain how a stability indicating method is different than a release (or potency) method.
(3) Describe the process for developing and validating a stability indicating method.