What is the Origin of Drug Substance Characterization?

This process is a fundamental requirement rooted in pharmaceutical chemistry and global regulatory guidelines, such as those established by the FDA and other pharmacopeias, to guarantee the quality of medicinal products. The concept is central to Good Manufacturing Practice (GMP).

What is the Mechanism of Drug Substance Characterization?

Characterization employs an array of advanced analytical techniques, including high-performance liquid chromatography (HPLC) to determine purity, mass spectrometry to confirm molecular structure, and nuclear magnetic resonance (NMR) spectroscopy for complete structural elucidation. These tests collectively establish a precise chemical fingerprint, confirming that the drug substance meets the stringent specifications required for clinical application and formulation stability.

Drug Substance Characterization ∞ Area

Drug Substance Characterization

Meaning

Drug Substance Characterization is the rigorous, multi-faceted analytical process of determining the physical, chemical, and biological properties of the pure, active pharmaceutical ingredient (API) intended for use in a compounded or manufactured hormonal preparation. This comprehensive analysis ensures the identity, purity, potency, and stability of the API, such as a bioidentical hormone or peptide, which is non-negotiable for patient safety and therapeutic efficacy.