This book is intended to serve as a resource for analysts in developing and troubleshooting
sample preparation methods. These are critical activities in providing accurate and reliable
data throughout the lifecycle of a drug product. This book is divided into four parts: - Part
One covers dosage form and diluent properties that impact sample preparation of pharmaceutical
dosage forms and the importance of sampling considerations in generating data representative of
the drug product batch. - Part Two reviews specific sample preparation techniques typically
used with pharmaceutical dosage forms. - Part Three discusses sample preparation method
development for different types of dosage forms including addressing drug excipient
interactions and post extraction considerations as well as method validation and applying
Quality by Design (QbD) principles to sample preparation methods. - Part Four examines
additional topics in sample preparation including automation investigating aberrant potency
results green chemistry considerations for sample preparation and the ideal case where no
sample preparation is required for sample analysis.
