Stability Study for Drugs, Personal Care Products and Cosmetics

What is Shelf life of Drugs, Personal Care/Cosmetic Products?

Shelf-life is the extent to which a product retains, within specified limits, and throughout its period of storage and use the same physical, chemical and antimicrobial specifications and characteristics that it possessed at the time of its manufacture and packaging. The product must retain 90% of the labeled claim at the end of shelf-life.

As per USP there are five types of stability studies:

Personal Care and Cosmetics testing usually covers chemical, physical and microbiological parameters. Therapeutic and toxicological are included in nutraceuticals, drugs and other health care products.

Parameter For Physical types studies:

Parameters for Chemical Analysis:

Parameters for Microbial Analysis:

Factors affecting Stability

When do we need stability testing and how they are conducted?

General Recommendations to Follow for a Shelf Life Study: