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Extractables & leachables

Extractables & Leachables Studies
Container Closure Systems & Medical Devices per USP/ICH​

Overview Service

Capzer Pharmaceuticals conducts comprehensive extractables and leachables (E&L) studies for container closure systems, packaging materials, and medical devices that contact pharmaceuticals. Our cGMP laboratory identifies organic/inorganic compounds extracted under exaggerated conditions and monitors leachables during normal use.​

Our Approach

Materials undergo solvent/time/temperature extractions per USP <1663>/<1664>, analyzed by UPLC-PDA-QQQ-MS (non-volatiles), DI/HS-GC-MS (volatiles/semi-volatiles), and ICP-MS (elementals). We characterize extractables profiles, identify toxicological concerns, and validate targeted leachables methods for stability programs.​​

Key Capabilities

  • Multi-polarity extractions (water, organic solvents, acidic/basic) with NVR analysis.
  • Full identification/quantitation supporting OINDP, injectables, and chronic therapies.
  • Regulatory reports bridging extractables to leachables for NDA/ANDA submissions.​​

Benefits for Partners

Partners secure patient safety data for Gabapentin capsules and Empagliflozin tablets from our FDA/DEA-registered facility, avoiding delays in commercialization while meeting FDA/EMA extractables-leachables expectations.

Other Service

Need for help?

Our expert team is here to support you with reliable pharmaceutical testing, analytical solutions, and regulatory guidance. Whether you have a query or need a customized service, we’re ready to assist you at every step.

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