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Isolation of Low Level Impurities for products slanted for regulatory approval (e.g. registration of novel agrochemical agents).

When bringing a product to market, regulatory approval requires the isolation and characterization of structures for all impurities exceeding 0.1% concentration in the technical material. Very often, the impurities belong to the same family of substances as the main component. The close structural similarity of the impurities and their low natural concentration add up to the difficulty of such projects.

Service Outline

  • Isolation of low level impurities in quantities sufficient for structural elucidation and for the required study
  • Ability to resolve and isolate components that co-elute in HPLC
  • Specialization in isolation of closely related synthetic products
  • Structural elucidation, component identification and documentation of impurities

Regulatory Approval?

To be able to sell, use, or biologically test your product the regulations set forth by various agencies such as the FDA, USDA must be met. The regulatory approval process requires the isolation and characterization of structures for all impurities exceeding 0.1% concentration in the technical material. To ensure accurate structural elucidation we work with cutting-edge laboratories to acquire high resolution NMR data, accurate mass spectroscopy and UV-VIS spectrum.

Impurity Isolation vs. Small Molecule Isolation

Although impurity isolation generally falls into small molecule isolation, it has its own distinctive character. Before the impurities can be purified by preparative chromatography their relative concentration must be brought up at least into a minimum range of 10 – 30% by the enrichment techniques, which comprise chromatographic as well as non-chromatographic methods. This usually constitutes the most difficult and time consuming stage requiring experience and skill. The final step is often done by preparative HPLC and often looks like a formality. Moreso, when dealing with bacterially derived products such as agrochemicals, the product comprises a single major component and several impurities that are structurally very similar. The structural similarity as well as the large disparity in concentration between main component and impurities requires non-conventional approaches.

Specialization in Wide Range of Agrochemicals

We have developed an extensive expertise in impurity isolation for some of those most challenging agrochemical products including abamectins, emamectins, pyrethrins, azadirachtins and others.

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