So, you have this fantastic new addition to your agricultural chemical product range and are rearing to get it to market. Waiting for the regulatory process to run its course can be frustrating experience. The process can be further delayed if your stability trials are not conducted properly, or if your overseas suppliers are not familiar with the Australian and New Zealand data requirements.
To avoid these unnecessary delays and missed sales opportunities, it is crucial to conduct stability trials meticulously and ensure that your suppliers are familiar with the specific regulations of your target market. This will help you to avoid rejection of data and ensure a smoother regulatory process. Taking the time to do this will pay off in the long run and help you bring your fantastic new product to market more efficiently.
Waiting for new product approvals can be a frustrating time.
Below, we have outlined seven common pitfalls and how to avoid them:
1. The formulation tested isn’t the one to be commercialised
Ensure that the supplied data relates to the declared formula to be registered. State it as a fact and cross-reference any formulation batch codes where available.
2. Trial batch size too small
The lab batch size should be large enough to be representative of commercial processes. The Australian Pesticides and Veterinary Medicines Authority (APVMA) requires a batch size of 5 litres (or kilograms).
3. Trial not conducted in commercial packaging
If the product is to be sold in 25L HDPE jerricans, then demonstrating its stability in a 20ml glass vial is not particularly helpful. Ideally, the smallest commercial pack should be used for stability trials. A scaled-down pack size, constructed of the same polymer, is also acceptable.
4. Trial conducted at inappropriate temperature or duration
If the product failed after 14 days at 54°C, then other conditions are also admissible. The next appropriate equivalent is 8 weeks at 40°C. Demonstrated stability at either of these conditions normally supports a 2-year ambient shelf-life. Other equivalent conditions must be technically justified.
5. Analytical test methods used for the active were inappropriate
To effectively monitor any degradation of the active, the test method should be capable of separating out any breakdown products. high-performance liquid chromatography (HPLC) and gas chromatography (GC) are particularly useful for this. Other methods, commonly used for routine product quality control (QC) testing, may not indicate stability (e.g., UV/Vis).
6. Analytical test methods used for the active not validated correctly
The data assessor wants to have confidence that the stability data supplied can be trusted. The APVMA guideline covers criteria to verify whether the analytical method can provide accurate and precise results. The requirements are prescriptive, and the method validation report should be clear and uncluttered so the assessor can tick all those boxes.
7. The product stability report is too brief or long
Supply exactly what’s required. Make it easy for assessors to review the report and avoid including unnecessary information.
Why Labtec for Stability Testing
Avoid the common pitfalls when conducting stability trials to ensure timely approval and the successful market launch of new agricultural chemical products to market. Labtec is an independent research and testing laboratory that specialises in providing customised solutions that meet the unique needs of our clients, including agricultural chemical companies.
AgChem Services
We understand the importance of avoiding common pitfalls when conducting stability trials, which is why we offer a broad range of analytical methods and expertise that can be tailored to support your specific needs. With Labtec, you can be confident in achieving reliable, accurate results that will support regulatory approval and market success. Contact us today to learn more about our stability testing services.
Reference and credit:
We would like to extend a special thanks to Ray Simms for compiling the original fact sheet in 2012 that provided valuable tips for conducting stability trials and which continues to be relevant. An updated version of the fact sheet is available for download and we encourage anyone in the agricultural chemical industry to take advantage of this valuable resource.