Introduction FDA expectations for Extractables and Leachables in CMC require pharmaceutical sponsors to demonstrate chemical compatibility through risk-based material characterization, […]
Introduction Evaluating COC and COP containers as glass alternatives highlights an advanced primary packaging strategy for sensitive biologics, parenteral formulations,
COC and COP Containers as Glass Alternatives: What Their Extractables Profiles Reveal Read More »
Introduction Uncontrolled migration of non-bonded plasticizers and the sorption of therapeutic drugs remain two major material-compatibility challenges associated with polyvinyl
Introduction: Sterilization changes an extractables and leachables profile because heat, radiation, or reactive gas alters the polymers, additives, and residues
Introduction Antioxidant extractables in pharmaceutical polymers comprise low-molecular-weight parent stabilizers, such as Irganox 1010 and Irgafos 168, along with their
Introduction Raw Material Characterization Before Extractable & Leachable Testing is essential for establishing an accurate chemical baseline, identifying thermal transition
Introduction Integrating Ion Chromatography and TOC in Extractables Studies is essential for addressing the significant analytical blind spots associated with
Introduction: GMP Extractables and Leachables Testing is a systematic approach to identifying, characterizing, and evaluating chemical substances that may migrate
Extractables vs. Leachables: When GMP-Grade Testing Becomes Mandatory Read More »
Introduction Headspace GC-MS for Volatile Extractables is a primary analytical technique used to isolate, identify, and quantify low-boiling organic chemical
Headspace GC-MS for Volatile Extractables: Residual Solvents, Monomers, and Degradants Read More »
Introduction Moving beyond NIST and Wiley commercial spectral databases is essential for effective extractables and leachables (E&L) screening because publicly
