Extractable and
Leachable
Studies

Mitigating patient safety risk through identification and quantification of harmful leachable impurities

At GVK BIO, we offer expert testing and consulting services to assess the safety and integrity of extractables and leachables in pharmaceutical products, container closure systems, and medical devices in accordance with US-FDA/ EMA and PQRI regulations.

E&L Studies are carried out for:

  • Semi/ non-volatile screening compounds using LC-MS, LC-MS/MS
  • Semi volatile compounds screening using GC-MS
  • Volatile compounds screening by HS-GC-MS
  • Screening of all metals by ICP-MS
  • We design protocols to drive method development, method validation and product samples which includes stressed/stability sample testing suitable for regulatory filing requirements across the globe.

Solutions we offer

  • Quick turnaround time with comprehensive report
  • Dedicated project management team
  • Analytical validations in accordance with applicable GMP/PQRI/USP regulations
  • Study of product contact material and safety risk assessment which includes metal testing
  • Extractable and leachable toxicological evaluation (in-silico) by VEGA software including risk assessment and validation
  • Quantitative and qualitative analysis of extractables and leachables

Brochure

Formulation & Analytical Solutions

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Whitepaper

Developability Assessment of Small Molecules

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