Method development and validation for multiple products

A supplements manufacturer asked RSSL to develop and validate two analytical methods suitable for the quantification of three vitamins across its extensive portfolio - all within a limited timeframe.

Background

A supplements manufacturer asked RSSL to develop and validate two analytical methods suitable for the quantification of three vitamins across its extensive portfolio - all within a limited timeframe.

Approach

The extensive product range presented many variables in terms of ingredient formulations, the vitamin forms used and different application formats which included powders, bars, tablets and syrups. This meant it was not possible to validate all the products within the given deadline; a single validation approach simply wasn’t possible.

As a result, the RSSL team and client arrived at a bespoke solution designed to reduce the number of validations required. This translated to a risk-based approach; where a number of “worst case scenario” models were formulated for each ingredient based on highest concentration levels and strongest impact.  

This complex situation was broken down into four stages:

  • Model preparation and selection of representative products: This involved collaborating with the client to collate a full ingredient listing and recipe breakdown for all products.  Analysis of this data enabled the development of approved models and the identification of key products which could be used to represent a range.  A blank (containing all the ingredients except the actives) was also prepared for each model to help with validation later on.
  • Method feasibility: In-house methods were used to analyse all the models and blanks, while also providing some feasibility. Each was then assessed in terms of its suitability for validation.
  • Method optimisation / development: In some instances, low level optimisation of the RSSL in-house method was required, which involved making adaptations to ensure suitability for validation. Remedial actions included optimising the extraction technique, for example, or modifying the chromatography conditions.
  • Method validation: The final stage involved specificity, linearity, accuracy, method precision (repeatability), robustness, as well as limit of detection and limit of quantification.

Results

By taking a pragmatic approach to a challenging situation, the RSSL team successfully developed analytical methods that were demonstrated to be fit for purpose across a wide range of vitamins and product types.

This tailored solution to method development cut back the number of individual products requiring validation by 75% - delivering significant time and cost savings to the client.  A positive outcome which successfully balanced commercial demands with scientific accuracy.

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