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Advanced E&L analytical solutions for regulatory compliance
Extractables and leachables (E&L) testing is essential for identifying potential contaminants from pharmaceutical packaging, manufacturing components, and drug delivery systems that may impact drug safety and efficacy. Thermo Fisher Scientific offers industry-leading E&L testing solutions, utilizing advanced analytical technologies and regulatory expertise to help pharmaceutical and biopharmaceutical companies ensure compliance with USP <1663>, USP <1664>, ICH, and FDA guidelines. Our comprehensive extractables and leachables analysis supports risk assessment, product safety, and patient health protection.
Solutions
Explore Thermo Fisher Scientific’s extractables and leachables testing solutions. Our comprehensive suite of analytical tools enables precise detection, identification, and quantification of potential contaminants, helping to ensure drug safety, regulatory compliance, and manufacturing efficiency.
Applications
Thermo Fisher Scientific offers extractables and leachables testing solutions for precise contaminant identification, risk assessment, and regulatory compliance. Our advanced tools help ensure drug safety, product integrity, and adherence to USP <1663>, USP <1664>, ICH, and FDA guidelines.
For Research Use Only. Not for use in diagnostic procedures.