Stability Studies

MCS can assist your company in the design and management of your stability programs.

Current Good Manufacturing Practices require that stability data be available for regulated products. The purpose of stability studies is to generate evidence on how environmental factors affect the quality of a regulated product. This permits the assignment of re-test dates or shelf life for the purposes of expiration dating.

Shelf Life Data

Shelf Life Data is required at the time of submission of a product license. Appropriate analytical studies need to be designed for two primary batches of regulated product. These studies may or may not include stress studies to elucidate degradation pathways of product components. Stress parameters may include temperature, humidity, light, oxidation and/or chemical insult. Analytical test methodologies need to be developed to account for degradation products.

On-Going Stability Studies

On-Going studies are designed to provide a continuous check on the manufacturing process of regulated products. Typically, one lot of a regulated product is selected to be placed on a stability program each year. Various parameters are analyzed and studied over the course of the product’s shelf life.

Under the GMP guidelines shelf life data and ongoing stability studies form the basis of a Stability Program. Prior to introduction of products onto the market, accelerated or other suitable models to predict shelf life must be completed.

MCS Associates designs and executes stability programs on behalf of many manufacturers, packagers and importers of regulated products.

Under the GMP guidelines shelf life data and ongoing stability studies form the basis of a Stability Program. Prior to introduction of products onto the market, accelerated or other suitable models to predict shelf life must be completed.

MCS Associates designs and executes stability programs on behalf of many manufacturers, packagers and importers of regulated products.



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MCS offers the following
services :
  • Stability Protocol Design
  • Shelf Life Stability
  • Accelerated and Intermediate Studies
  • Stability testing for IND, NDA, ANDA
  • Formulation Evaluation Stability Testing
  • Forced Degradation Studies
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