Analytical Services

We offer GLP storage stability testing for plant protection products (PPP) and biocidal products (BP).

Our highly experienced team will analyse the product’s physical, chemical, and functional attributes over set periods, under controlled temperature conditions. The conditions are dependent upon the product type, recommended storage temperature and the markets into which the product is to be sold.

This testing is a necessary part of product registration to establish if the product is unchanged when stored for a period of time following production.

Purpose

During storage, PPPs may undergo chemical and physical changes at a rate which depends on the nature of its active ingredient(s), co-formulants, formulation type, packaging material and storage conditions. The product remains fit for use if changes have no negative impact on its applicability, biological performance and operator-consumer, or environmental safety

Types of Stability Studies

We can offer the following:

Long-term Stability Studies:  Storage is usually performed at ambient temperature for at least 2 years or longer.

Accelerated Stability Studies:  Study is conducted under more extreme conditions (higher temperatures) to mimic the degradation process at a faster rate.  Different storage regimes as defined in CIPAC MT 46.4 and referred to in the FAO/WHO manual can be used to perform accelerated storage tests. The listed alternative conditions (2 weeks / 54°C, 4 weeks / 50°C, 6 weeks / 45°C, 8 weeks / 40°C, 12 weeks / 35°C, 18 weeks / 30°C) are accepted as equivalent.

Testing

Regulatory requirements provide limits for the content of active ingredient(s) and/or toxicologically relevant impurities as well as for key physical properties of the product.

For analysis of the content of active ingredients and/or relevant impurities, validated company internal methods or published methods, e.g. by CIPAC when available, can be used.

Analytical Techniques Used:

• High-Performance Liquid Chromatography (HPLC)
• Gas Chromatography (GC)
• Ion Chromatography (IC)
• Mass Spectrometry (MS)

For most key formulation types, the FAO/WHO manual provides guidance on the physical parameters required to be tested before and after storage.

Regulations

Storage Stability Studies align with the following key regulations, ensuring your products meet all legal and safety standards:

Plant Protection Products Regulation – Regulation (EC) No 1107/2009

REACH – Registration, Evaluation, Authorisation and Restriction of Chemicals