Accelerated Storage Stability: EPA Guidance Brings Opportunity to Registrants
Recently, ATS Labs has received a number of inquiries from clients on how to take advantage of the new accelerated stability study conditions authorized by the EPA Office of Pesticides Program (OPP) in a November 2012 guidance. The OPP suggests that registrants may use an elevated temperature of 54°C ±2°C for 14 days as a substitute for the previous guidelines for stability (830.6317) and corrosion characteristics (830.6320).
This guidance offers a great opportunity for registrants to save both time and money, by reducing both the time necessary for product submission and the number of testing time points.
While this change has provided an excellent opportunity, it should be noted that the guidance places a significant amount of responsibility, in determining the how appropriate these protocol changes would be, in registrant’s discretion.
“However, the Agency does not consider all products/materials appropriate for this protocol. Registrants must make the determination based on THEIR KNOWELDEGE of the physical and chemical properties of their products (such as thermal properties, volatility, packaging, and whether any incidents related to product instability are known), whether or not their product are suitable for this study or whether the one-year study is more appropriate.”
In many cases, the identity of the active ingredient will be the determining factor in selecting which protocol is appropriate for your product. Some insight may be gleaned from the raw data included with the guidance as to the classes of compounds that have been found suitable for the protocol in the past. This information, coupled with real stability data generated for other similar products can offer valuable insight into whether or not you can take advantage of the 14 day stability study.
Is the Accelerated Storage Stability Study Right for Your Product?
To ensure successful product submission, you must determine which stability study conditions are right for your product and fulfill the testing requirements. ATS Labs has the expertise to determine the appropriate study conditions and the testing capability to perform product storage stability testing. Learn more about our chemistry services or contact us to discuss whether 14-day accelerated storage stability is a viable option for your product.