CRED Getting the CMC Dossier Right 2024

28/08/2024

Specification Tests Overview

Universal Tests:

● Description

● ID

● Assay/potency

● Impurities

Specific Tests (defined by DS + requirements of DP):

● Physico-chemical properties

● Particle size

● Polymorphic forms

● Chirality

● Microbial limits

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Drug Substance – Quality Attributes

Description

● Visual test ● Appearance

Identification ● Specific tests to discriminate between related compounds of similar structure (validated)

● Typically IR spectroscopy, compare spectra to Reference Standard ● HPLC RT not sufficient (combined RT plus orthogonal test is acceptable) ● If a salt, ID for the salt itself ● Confirmation of chirality (if appropriate)

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