By Aryo A. Nikopour, Nitto Avecia Pharma Services
There is no shortage of guidance for conducting extractables and leachables studies.
For instance, U.S. Pharmacopeia and the Product Quality Research Institute (PQRI) offer separate and useful recommendations.
However, an ideal approach is to combine guidance from both organizations, says Aryo A. Nikopour, Senior Vice President of Scientific and Technical Services at Nitto Avecia Pharma Services.
Despite differences in nomenclature, both organizations seek similar outcomes, Mr. Nikopour says.
They instruct developers to first identify extractables as tentative leachables, then as probable leachables using model extraction (also known as simulation), and finally as confirmed leachables in support of shelf-life studies for the final container closure system, he adds.
The trick is aligning standards that overlap.