Analytical chemistry is a critical component of any safety study, ensuring that test conditions are accurately characterised and scientifically robust

By precisely measuring the concentration, stability and fate of test substances throughout the study, our rigorous analytical support provides confidence in data integrity, strengthens the interpretation, and supports reliable risk assessments.

We provide:

  • Analytical Method Development and Validation
  • HPLC analysis
  • Quantitative LC-MS analysis
  • GC and GC-MS analysis
  • Certificate of Analysis
  • Identification of unknown metabolites

 

services-es-36

Analytical support for human safety, environmental safety and metabolism studies

The analytical chemistry teams play a supportive role to all our services area and sites.

Expand_img

Analytical chemistry plays a critical role in supporting ecotoxicology, residue, human exposure, metabolism and environmental fate studies. These studies rely on accurate and reliable data, which begins with precise analysis of the test item. However, this process can be challenging due to factors such as complex matrices, low detection limits, and the need for method development. To overcome these hurdles, a strong team of analytical chemists is essential.

Why analytical expertise matters:

  • Foundation for regulatory studies: Accurate analysis ensures the validity of ecotoxicology and environmental fate results;
  • Complex challenges: Test items often require specialised methods due to unique chemical properties or environmental conditions;
  • Advanced techniques: High-sensitivity instrumentation and tailored approaches are needed to meet strict detection and quantification requirements;
  • Expert problem-solving: Skilled chemists can adapt methods and troubleshoot issues to maintain data integrity and compliance.
storage-stability

Storage stability

Storage stability data is a key step in demonstrating evidence of product’s efficacy and safety over time.

Expand_img

It is important to determine shelf-life, along with accelerated studies to assess potential degradation process in a shorter period, highlighting potential issues early on. We can provide:

  • 2 year shelf-life specification at ambient (CRD and FAO/WHO)
  • 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)
product-chemistry-lab-copy

Five batch analysis

Each amount of active ingredient is tested and any impurities above a set level are identified and quantified.

Expand_img

Our 5-batch specialists are based at key laboratory locations around the world, ready to support you with your preliminary analysis, in accordance with the various global regulatory directives. Studies are conducted as follows:

  • Pre-screening of 5-batches for impurities including 3D screening
  • Impurity identification and structure elucidation in consultation with the sponsor
  • Isolation/synthesis of impurities required for 5-batch analysis
  • GLP analysis of 5-batches using validated analytical methods for active ingredient content and impurities
  • Characterisation of 5 commercial batches along with reference standards by UV, IR, NMR, LC-MS/MS and/or GC-MS as applicable