The Complete Guide to Stability Testing For OTC and Prescription Drugs

There are several stability tests that virtually all Over-the-Counter and Prescription (Rx) drug products must undergo in accordance with current FDA and ICH Guidelines and cGMP requirements.

These guidelines can be complex and confusing, but they are required in order to distribute Over-the-Counter (OTC) and Prescription (Rx) drug products within the USA.

Our guide covers everything you need to know about stability testing, including:

• What Products Must Undergo Stability Testing?
• What Types of Stability Studies are Commonly Conducted for Drug Products?
• How to Determine Expiration Dating for the Launch of a New OTC Drug Product
• How to Interpret Accelerated Stability Studies
• How to Support a 3-Year Expiration Date
• General CGMP Requirements for Conducting Stability Studies
• …and more!

About Consumer Product Testing℠ Company

CPT℠, the original Consumer Product Testing℠ Company, has been providing the industry with accurate and compliant data for 45 years.

With an unrivaled, world-renowned reputation for excellence, quality results, the best talent and state-of-the-art technology, only one name is synonymous with quality: CPT℠.