Custom Synthesis
Over the last 17 years EPP Ltd have accumulated vast experience in the custom synthesis of the various types of certified analytical reference standards described, on a scale ranging from milligrams [for initial identification purposes] to kilograms [for toxicity, process validation and environmental fate studies], and at a purity ranging from 95 – 100%.
Described below is the full range of analytical reference standards that EPP Ltd can provide
• Synthesis of manufacturing impurities present in active substances
Manufacturing impurities are often close in chemical structure to the parent pesticide. To obtain product approval, those manufacturing impurities present at greater than 0.1% in 5 typical production batches of the technical grade active ingredient (TGAI) or active substance require to be identified and quantified as part of registrations conducted to GLP standards by accredited laboratories.
• Synthesis of metabolites
Metabolites are chemical compounds related in structure to the parent pesticide. The pesticide has undergone biochemical modification in vivo (eg within a plant).
These metabolites often require to be identified and quantified, and toxicity studies undertaken on the pure metabolites, as part of GLP regulatory submissions for approval of pesticide products.
• Synthesis of internal reference standards
Internal reference standards are chemical compounds which are required for the accurate quantification of the levels of a pesticide, related impurity or metabolite. They are used for method validation and Quality Control purposes including GLP studies.
• Synthesis of stable isotopically labelled reference standards
Stable isotopically labelled reference standards are a type of analytical reference standard used for fast and accurate quantification of low levels of compounds, typically metabolites, using analytical techniques such as Liquid Chromatography-Mass Spectrometry (LC-MS) or Gas Chromatography-Mass Spectrometry (GC-MS). EPP Ltd has the capability to synthesise 13C, 2H, 18O & 15N labelled compounds
• Synthesis of degradation impurities
Degradation impurities are chemical compounds related in structure to the parent pesticide. They arise during storage (or forced degradation studies), and often require to be identified and quantified as part of GLP regulatory submissions.