Storage Stability

Storage stability trials determine the shelf-life of products. This information is a crucial step within the registration process of biocidal products. A longer shelf-life is often preferred along with accelerated studies to assess potential degradation process in a shorter period.

Eurofins BioPharma Product Testing Italy provides GLP compliant stability studies in accordance with all current guidelines in relation to biocides, chemicals and other products such as biostimulants and plant protection products. 

• We can design storage stability studies, with or without GLP accreditation, under the Biocides, Plant Protection, ICH guidelines or Croplife (formerly GIFAP) Monograph N. 17, FDA guidance, ASTM or pharmacopeia to support the registration of your products worldwide. Where published methods are not available standard in-house procedures are followed which are (or can be) fully validated.
• 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, including low temperature stability.
• We offer custom-made testing solutions to fulfil the requirements of your particular product.
• Our testing offer apply suitable methods of analysis such as CIPAC/OECD/EEC to comply with the appropriate regulatory authority guidelines. 
• Our expert team can also design studies specific to your project needs, and our experienced Method Development and Validation team is available for any additional services you may require.
• In addition, our team regularly develops and validates methods for the Active Ingredient(s) and any relevant impurities required.

Our facility can meet the specific storage requirements of any project with the ability to provide alternate temperature and humidity conditions.

• Cold storage stability
• Freeze / thaw stability (FAO/WHO)
• 20°C(+/- 2°C)/Ambient RH
• 25°C (+/- 2°C)/Ambient RH
• 30°C (+/- 2C)/Ambient RH
• 35°C (+/- 2C)/Ambient RH
• 40°C (+/- 2C)/Ambient RH
• 5°C (+/- 3°C)/ Ambient RH
• 54°C (+/- 2C)/Ambient RH
• Light
• Customized
• 25°C ± 2°C/ 60% HR ± 5%
• 40°C ± 2°C / 75% HR ± 5%
• 30°C ± 2°C/ 65% HR ± 5%
• 30°C ± 2°C/ 75% HR ± 5%
• 25°C ± 2°C/ 40% HR± 5%
• 25°C ± 2°C/ 40% HR± 5%
• 55±2°C
• 30°C ± 2°C/ 35% HR ± 5%
• 2-8°C
• -20°C ± 5°C
• - 70°C
• -80°C
• -40°C ± 5°C

• Cold storage stability (CRD and FAO/WHO)
• Freeze / thaw stability (CRD and FAO/WHO)
• Accelerated storage stability for 2 weeks at 54°C or other temperatures (CRD and FAO/WHO)