Virtually all Over-the-Counter OTC and Prescription Rx medication Products distributed within the USA have to include an expiration date in their labelling. Expiration dates must be supported by stability testing that has been conducted in compliance with present FDA and ICH Guidelines and cGMP requirements.A stability study is a program of testing that is designed to Provide evidence on how the quality of a drug substance or drug product varies with time under the influence of many different environmental factors.These variables include temperature, light and humidity. Stability Testing enables the recommended storage conditions, retest intervals and shelf life to be established. Refer to FDA Guidance for Industry Q1AR2 Stability Testing of New Drug Substances and Products
What Sorts of Stability Studies Are Generally Conducted for Drug Products?
The Stability Testing are required to be conducted on drug products Under the conditions of storage appearing on the product label, including any other conditions that the drug product may be exposed to during production, storage and transport activities.Consequently, there are a number of equilibrium conditions which are Commonly employed to ascertain the stability of a drug product in its advertised bundle s. Examples of the most common types of stability studies are as follows. A stability study conducted under controlled temperature and Humidity approximating conditions of storage.For drug products distributed within the USA, long-term Stability storage requirements are 25 +/- 2oC with 60 +/- 5% RH.A stability study conducted under exaggerated conditions in an effort to accelerate the aging process, i.e., the rate of chemical degradation and/or bodily change.
For drug products distributed within the USA, virtually all Accelerated stability studies have been conducted under storage requirements of 40 +/- 2o C with 75 +/- 5% RH.A stability study that is conducted under conditions which are Involving long-term and accelerated storage requirements.For drug products sold within the USA, intermediate Problems are 30 +/-2oC with 65 +/- 5% RH.Samples stored under intermediate states are generally just tested if a failure is encountered during the testing of samples stored under accelerated storage conditions.A study that is conducted in 5oC without humidity control to Determine the impact that freezing and subsequent thawing depends upon the stability of a product.Such studies could be conducted with multiple or single Freeze/thaw cycles, with three 3 cycles being the most commonly employed.