Unknown Component

Characterization and Tracing of Unknown Components and Impurities

In many applications, the presence of an unknown component or impurity—even at trace levels—can compromise product quality, cause failures, or render a product unusable. Such contaminants can originate from multiple sources and, once present, are often difficult to eliminate.

With over 30 years of experience and a comprehensive range of analytical capabilities, CA Analytical Testing Services specializes in solving these challenges. Our proven methodologies, tailored to specific material types, allow us to efficiently isolate and identify unknown substances, then determine their origin.

Potential sources of unknown or impure materials include:

• Process-related contaminants
• Degradation of active pharmaceutical ingredients (API) or other formulation components
• Oxidized polymer additives
• Unreacted monomers or oligomers
• Extractable and leachable substances from packaging or processing equipment

CA Analytical Testing Services has the expertise partner with our clients to pinpoint the identity of unknowns or impurities and also trace them back to their source, helping our clients prevent recurrence and maintain product integrity.