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Impurity Analysis & Identification in Biopharmaceuticals

GMP Isolation & Characterization of Impurities

Drug development timelines can be extended and marketed drugs may need to be recalled due to the presence of impurities in biopharmaceutical products. Impurity analysis is crucial, since impurities can impact the safety and efficacy of biopharmaceuticals, and these unwanted chemicals remain with the drug formulation or active pharmaceutical ingredient (API). Impurities can result from the manufacturing process and/or storage and can be introduced from a variety of sources, such as unintended by-products of API and/or excipients degradation. Additionally, process impurities from API and excipients manufacturing may be present, and impurities can be introduced into the drug product from container-closure contact. According to International Council for Harmonisation (ICH) Q3A – Q3E guidance, there are five primary categories for impurities associated with pharmaceuticals: impurities in new drug substances, impurities in new drug products, residual solvents, elemental impurities, and extractables/leachables. Examples of impurity sources include starting materials, intermediates, degradation products, unintended by-products, interaction products, reagents, catalysts, ligands, heavy metals, residual metals, residual solvents, or process aids used during production.

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Impurity analysis and characterization includes impurity identification, structure elucidation, and quantitative determination of impurities and degradation products in bulk materials and biopharmaceutical formulations. Acceptable limits for impurities as well as recommendations for impurity testing are detailed in both ICH and FDA guidance, including USP <1086> Impurities in Drug Substances and Drug Products. Avomeen’s Ph.D.-led teams of scientists can isolate and characterize impurities in accordance with FDA and ICH guidelines and are adept at developing and validating methods for monitoring impurities in biopharmaceutical drugs and raw materials.

Avomeen offers:

A comprehensive approach to impurity analysis and characterization, with wrap-around services including reference standard characterization and management, E&L, stability programs, and analytical investigational services Consultative teams of scientists well-versed in FDA and ICH regulatory guidance with decades of practical experience with impurity identification in biopharmaceuticals and excipients Flexible and customized solutions that range from impurity characterization to identification of its source with a variety of analytical techniques, including analyzing raw materials, reagents, and processing aids

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USP & ICH Impurity Profile Services

Avomeen’s full-service solution to impurity characterization ranges from identifying process-related impurities and residual solvents to extractables and leachables (E&L) and forced degradation studies. Our team of consultative, expert scientists provide support throughout the entire product development lifecycle.


Sample Matrices Experience:

  • Tablets
  • Capsules
  • Suspensions
  • Injectables
  • Suppositories
  • Powders and granules
  • Syrups
  • Inhalants
  • Oral and topical liquids
  • Creams, ointments and gels
  • Oligonucleotides and biologics
  • Combination products

Identify Impurities with Avomeen’s Comprehensive GMP Impurity Characterization Services

Our regulatory and industry experts ensure that every client receives the Avomeen standard of regulatory guidance that has helped countless organizations bring revolutionary biopharmaceutical drugs and therapeutics to market, all while meeting specifications and timelines. Get in touch with an expert to explore a partnership with Avomeen.

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