Storage Stability Trials

Storage Stability Trials determine the shelf life of products. This information is a necessity for registration and the process of evaluation covers both the product and the packaging of that product. 

Oxford Analytical is a highly proficient GLP compliant laboratory with extensive experience in performing stability studies in accordance with all current guidelines in relation to plant protection products, Biocides and Biostimulants.  

For example, our team are able to provide storage stability studies in support of the registration of Plant protection products as outlined in Annex III of Directive 91/414/EEC and Regulation (EC) No. 1107/2009 of the EU parliament and council on placing plant protection products on the market.

We can design these studies in accordance with guidance documents such as Croplife (formerly GIFAP) Monograph No 17. 

We have extensive experience with Biocides since the introduction of the Biocidal Products Regulation (EU) No 528/2012 of the European Parliament.

Our studies offer a range of temperatures, conditions, and lengths of storage to meet your requirements. For example, 2- and 3-years storage under ambient conditions as well as accelerated storage stability at 54°C, 35°C and 30°C. 

There are many variable test requirements dependant upon the particular formulation under test. Therefore, we will tailor your suite of tests to fulfil the requirements of your particular product.

These testing packages employ suitable methods of analysis such as CIPAC/OECD/EEC to comply with the appropriate regulatory authority guidelines. 

We are proficient in adapting and modifying published methods to suit the requirements of your product and, as such, are able to support successful registration.

Oxford Analytical also comply with FDA guidance as well as follow ASTM or pharmacopeia methodology. Where published methods are not available standard in-house procedures are followed which are (or can be) fully validated. 

We have also developed in-house procedures to conduct analyses on the effectiveness of cleaning procedures and also perform spray performance testing over time for RTU (ready to use) formulations. This is now a registration requirement, and our methodology can be adapted to cover your company’s recommended cleaning or product use procedures.

In addition, our team regularly develops and validates methods for the Active Ingredient(s) and any relevant impurities required.

Please contact us for a tailored quotation.

 

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