4. Extractable & Leachable - EFRAC | Drug, Food, Gas, Proficiency Testing Laboratory
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    EXTRACTABLES AND LEACHABLES

    Extractables and Leachables are a Group of Compounds that can be of Potent Risk and may infuse a Serious threat to Pharmaceutical Manufacturers producing API, Generics, and Formulation End Products for both Domestic & Export Market. When Elements and Compounds leach into Products, from Packaging or Manufacturing Conditions they can render them unfit and even dangerous for use.

    Leachables analysis identifies Substances that migrate from Polymeric, Metallic or Glass Material into the patient and are typically a subset of those identified in the Extractables Analysis. This type of Analysis is required when there is a risk that harmful Substances may have leached into a Liquid Product, such as Eye Drops, from its Container or Packaging.

    The Assessment of Extractables and Leachables in Bio-Pharmaceutical Products is an important step in Drug Product Development. Processing Equipment, as well as, Primary and Secondary Container Closures are Potential Vectors for Chemical Contaminants.

    Extractables Analysis identifies the Categorization and Quantification of Substances that could potentially migrate from Polymeric, Metallic, or Glass Material under Storage Conditions into the Consumer’s body with any of the Medicines consumed by them during the process of treatment. It includes Monomers and Polymer Additives such as Antioxidants, Plasticisers, Stabilizers, Dyes, Metal Catalysts & other Harmful Chemicals.

    EFRAC’s facilities include different branches of Research and Analysis like Drug and Pharmaceutical Services, Microbiology, Trace and Ultra-trace, Analytical Services for Food and Water, Leachable and Extractable Studies, Stability Studies, Environmental Services, and Training. EFRAC’s Scientists have a thorough knowledge of Analyzing Unknown Chemical Compounds and Skilled Expertise in Separation Techniques..

    Efrac- Extract

    Pharma Specialized Services ………........ Extractable & Leachable

    Services

    INSTRUMENT

    • HPLC-UV, DAD • HS-GC, HS-GC-MS • GC (FID, ECD, FID-NP), GC-MS • GC-TEA (Nitrosamines) • ICP-OES, ICP-MS, AAS, FTIR • TGA, DSC • Particle Size Analyzer

    METHODS

    USP <1663>, USP <1664>, EMA – CPMP / QWP/ 4359/03, ICH – Q3A (R2), PQR5 (Mar 07, Sept 06), USFDA Guidance for Industry (1992, 2002)