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Our R&D team were asked to develop and validate a robust analytical method that could be used to confirm the stability of the client’s novel carbohydrates. Both the method and resulting data needed to meet stringent regulatory requirements for a successful novel food application.
We first needed to understand the structure of the compound and how the method would be used. After establishing that the novel carbohydrates would be analysed in the finished product, rather than as a raw material, we clarified the specific food matrix and dosage level.
By working closely with the product development team, we were also able to confirm that other ingredients within the formulation would not interfere with the novel carbohydrates during analysis. If a problem had been identified, however, alternative ingredients with similar properties could have been considered for use in the recipe for the purposes of evaluation.
Following completion of the initial scoping phase, we selected the most suitable chromatography technique from the wide range of options available at RSSL, based on compound chemistry and the level of precision required for the method.
The next step involved carrying out a series of experiments to find the optimal analytical parameters such as pH, extraction solution, mobile phase, type of chromatography column and separation conditions. In each case, it was important not to rush and ensure we achieved maximum recovery, as well as precise and accurate quantification of the novel carbohydrates.
The same conditions were then optimised and taken forward for method validation. By carrying out this final stage, we verified that the analytical process developed for the novel carbohydrates was fit for purpose and could accurately quantify the compound of interest for the intended use. Information that was crucial for the novel food submission.
Our validated method was used to perform the stability study required for the novel food application and ensured both client and regulator were confident in the data. The dossier submission was subsequently approved. Our extensive expertise in method development and validation ensured that the optimum method was available for subsequent assessments, to generate data for the actual regulatory dossier.
RSSL’s in-depth knowledge and understanding of both method development and validation made this a seamless process
When bringing new ingredients to market, we understand that constantly shifting regulatory rules are challenging. Our specialist team interprets and understands complex requirements to ensure your product is fully compliant, and has the experience and technical capabilities to deliver it.
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