The Means to Monitor Chemical Migration - Pharmaceutical Technology

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The Means to Monitor Chemical Migration
Industry associations will soon provide new recommendations about extractables and leachables.

Pharmaceutical Technology
Volume 35, Issue 6, pp. 40-42

Understanding disposable components
The new publication will present the safety thresholds and analytical-evaluation thresholds for leachables. The leachable's analytical-evaluation threshold is derived from the scientifically justified safety-concern threshold and defines the level above which scientists should begin to identify and assess leachables. The document also will offer advice about applying the thresholds, taking into consideration factors such as dose duration, patient population, and product-specific characteristics.

As part of its preparation for drafting the document, PQRI performed extraction and analytical testing on various example materials. The group's results will form the basis for its recommendations for the best approaches for performing controlled extractions, including rationales for selecting various types of solvents and recommendations for appropriate analytical methodology in extractables and leachables testing. The document will offer examples to illustrate how PQRI applied its methods to materials commonly used in parenteral and ophthalmic drug products.

Drugmakers will also find advice about thresholds for known leachables in the final document. The document's authors will establish categories for known leachables based on safety concern levels, says Paskiet. Additional topics will consider the best demonstrated practices for studying secondary packages, such as labeling. The document will also help scientists determine whether simulation studies are appropriate after a material has been fully characterized, says Paskiet. The group currently is acquiring data about these subjects.

In some respects, parenteral and ophthalmic therapies call for an approach different from that for inhaled drugs, partly because more of the former products are aqueous-based, and partly because parenteral and ophthalmic drugs can be potent or used for short durations.


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