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Validating a faster assay for residual solvent screening

Residual solvent screening is a routine part of many testing programs, and the method the lab has used for it has been reliable for a long time — reliable, but not fast. A revised version of the assay is now working through validation, with the goal of cutting runtime without giving up anything on sensitivity or specificity.

The revised method changes the chromatographic run conditions to shorten the time each sample spends on the instrument, while keeping the same detection technology. On paper that's a small change; in practice it's the kind of adjustment that has to be re-proven from scratch before it can touch a client's result.

Validation for a change like this follows the same structure as validating any new method: accuracy, precision, linearity and limit of detection are all re-established against reference standards, and specificity is confirmed against the same set of solvents the original method covers. Nothing about the process is skipped just because the underlying chemistry is familiar.

The method has cleared its validation runs and is now going through internal review and sign-off before it's released for general use. That review step is deliberately separate from the bench work — a second set of eyes on the data before anything becomes a standard offering.

Once approved, the faster method will replace the current one as the default for residual solvent screening, and results will be reported the same way clients already see them — nothing changes about how a certificate reads, only how quickly it can be issued.

This is one of several methods currently working through the lab's validation pipeline. Updates on the others will follow as they clear their own review.

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