Product quality
Testing & Product Quality
What COAs, identity testing, purity assays, sterility testing and product traceability can and cannot establish.
Identity, purity and sterility are different questions
Analytical identity, chromatographic purity, active content, sterility and endotoxin testing answer different questions. One number cannot stand in for all of them.
COA checklist
Review traceability, test methods and missing fields.
Open checklist →Identity registry
Keep molecule, salt, fragment, formulation and market nickname separate.
Identity →Storage & handling
Understand why formulation state changes stability assumptions.
Storage →Safety unknowns
Product-quality uncertainty adds to, rather than replaces, biological safety uncertainty.
Safety →