Selection of key extractables for leachables study

Client

A pharmaceutical product manufacturer

Background

Analytical headspace studies, extractables studies (using solvents) and a stressed leachables study had been carried out on a single dose, prefilled syringe system used to store and deliver (by subcutaneous injection) a drug to stimulate neutrophil production in patients undergoing cancer chemotherapy. The client asked bibra to propose, with a justification, a list of the extractables that were likely to be health-critical, for monitoring in subsequent leachables studies.

Project goals

To generate a report selecting the extractables likely to be health-critical, for follow-up in a leachable study, together with a justification for the selection.

Approach

Selection was based on a professionally-registered toxicologist’s knowledge of the relationships between toxicity potential and structure. At this stage, no appraisal of the toxicological literature was undertaken. The selection was based on a combination of anticipated inherent toxicity potential and the analytical laboratory’s estimated exposure values. Bibra noted that much of the literature toxicity data have been generated by the oral route, and that a subsequent formal health risk assessment, based on the analytical results of a leachables study, would take account of the potential impact of differences in exposure route.

Bibra project leader

Pete Watts

Extractables & Leachables studies

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