The Importance of Radiochemical Purity
Over the years, the requirements to support registration or re-registration of an agrochemical have become increasingly rigorous and the data requirements more complex. Regulatory guidelines for obtaining the required data are published by Government agencies and in many cases, the use of a radio-labeled compound is considered mandatory so the fate of an agrochemical can be qualified and quantified in the system to which it is applied.
Before studies using radiolabeled compounds can be dosed, a radiochemical purity check must be conducted. This ensures the stock radiochemical meets the required standard for application on the study which is typically > 95-98% radiopurity, contingent on the study type. If the analytical results indicate insufficient purity to dose, that can result in costly delays to programs of work whilst a new batch of radiochemical is synthesized or is shipped with sufficient radiochemical purity.
Webinar: Reducing Risk in Agrochemical Development
Bringing novel solutions to market in the agrochemical industry is a high-risk journey filled with obstacles. Learn how to minimize risk.
Watch the Webinar
Improving the Radiochemical Purity of your Radiolabeled Compound
To mitigate delays, Charles River offers a rapid turnaround repurification service for 14C and 3H labeled radiochemicals. Impure material is repurified using flash chromatographic techniques and radio-high resolution LC-MS used to determine radiopurity and chemical authenticity. A new Certificate of Analysis is then issued making use of precious existing material and avoiding costly re-synthesis and protracted delays.
For the most sensitive radiochemicals, the repurified material can be provided to coincide with dosing the follow-up studies or shipped wherever needed.
Where required, high resolution LC-MS can be used to provide an early insight into the nature of degradants and specific activity determined where multiple batches are combined. Offering experienced insight and seamless execution, our laboratory science team delivers the material that will keep your program of work on schedule.
Speak to us to find out more, simply provide us with any known information on your radiochemical and requirements to see how we can help ensure radiochemical purity.