Unit 4: Solid-State Characterization
Solid-state characterization evaluates particle size, morphology, crystallinity, and thermal behavior to ensure stability and performance of drug substances. Techniques include XRPD, DSC, FTIR, Raman, SEM, TEM, and particle size analysis using Malvern instruments.
Definition
Solid-state characterization involves analyzing the physical and chemical properties of drug substances and excipients in solid form to ensure stability, compatibility, and performance.
These techniques help identify polymorphism, crystallinity, particle size, and thermal behavior, which influence solubility, dissolution, and bioavailability.
Key Points
Critical for predicting stability and formulation performance
Includes particle size, morphology, thermal and structural analysis
USP references apply for particle size and polymorphism studies
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