DSTC Working Groups (WGs) deal with regulatory and scientific issues in the area of drug substance.
The Impurities WG is determining appropriate methods and extent of characterization for impurities as a function of the stage of product development.
The Physical Attributes/ Particle Size WG is discussing test methods and specification-setting for particles of active pharmaceutical ingredients in oral dosage forms.
The Specifications/ BACPAC WG is considering a core set of specifications (test, analytical methods, and acceptance criteria) that would assure the identity, strength, quality, purity and potency of a drug substance following a manufacturing change after the final intermediate.
