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Characterization & identification of impurities in pharmaceuticals products by LCMSMS

LC-MS/MS Impurity Characterization & Identification
High-Resolution Structural Elucidation for Pharma Safety​​

Overview Service

Capzer Pharmaceuticals provides advanced characterization and identification of impurities in pharmaceutical products using LC-MS/MS technology. This service supports ICH-compliant impurity profiling for drug substances, finished products, and degradation studies, ensuring regulatory compliance and patient safety.

Our Approach

Our FDA-registered lab employs UPLC-MS/MS, HPLC-MS/MS, and high-resolution mass spectrometry with ESI/APCI ionization for precise molecular weight determination, fragmentation patterns, and structural confirmation. We conduct forced degradation studies, extractables/leachables analysis, and nitrosamine detection per USP/EP requirements, delivering detailed reports with proposed structures.​​

Key Capabilities

  • Trace-level organic impurities, process-related byproducts, and degradation products.
  • Genotoxic impurity (GTI) screening and elemental impurities integration with ICP-MS.
  • Method development for complex matrices across tablets, APIs, and formulations.​​

Benefits for Partners

Partners receive actionable impurity data to resolve OOS investigations, support ANDA filings, and optimize manufacturing processes. Integrated with our 20,000 sq. ft. GMP facility, this accelerates generic development for chronic therapies while minimizing regulatory risks.

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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