The purpose of stability testing is to deliver indication of how the quality of an Active pharmaceutical ingredient fluctuates with time under the effect of a multiple environmental factors such as temperature, humidity and light
The stability program also contains the study of product-related factors that effects its quality, such as interaction of Active pharmaceutical ingredient with excipients, container closure systems and packaging materials
Various stability testing procedures:
- Stress testing of the Active pharmaceutical ingredient can assist to recognize the probable breakdown of products, that consequently aids in establishing the degradation pathways and the fundamental stability of compounds and prove the power of the analytical procedures used for indicating stability.
- Container closure system :The steadiness studies has to be done on the Active pharmaceutical ingredient packaged in a container closing system that triggers the packaging proposed for storage and distribution
- Specification: The study of stability has to contain testing of those characteristics of the Active pharmaceutical ingredient that are vulnerable to transformation during storage and possibly effect the quality, safety and efficacy. The testing should cover, physical, chemical, biological and microbiological attributes
- Testing frequency: The frequency of testing should be adequate to establish the stability attribute of the Active pharmaceutical ingredient. For Active pharmaceutical ingredient with an expected repeated test stage or shelf life of at least 12 months, the regularity of trying long-term storage state must usually be once in 3 months in the first year, and then every 6 months in the second year and then once a year for the remaining life term
- Storage conditions: Conventionally an Active pharmaceutical ingredient should be examined under storage conditions that test its heat stability and moisture sensitivity as well. The length of study and the condition in which storage is done is generally enough to cover shipment and storage.