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usp-10311-analytical-instrument-qualification-for-extractables-studies
Extractables and Leachables 21 CFR 174.5 General Requirements for Indirect Food Additives – E&L21 CFR 175.300 Resinous and Polymeric Coatings – Leachables Control21 CFR 176.170 Substances in Contact with Aqueous Foods – Extractables21 CFR 177.1520 Leachable Migration Limits for Polyolefins21 CFR 177.1630 Polyethylene Terephthalate Polymers – Leachables LimitASTM D6288 Volatile Organic Compounds Determination by GC/MSASTM D6499 N-nitrosamines Extraction from Rubber ComponentsASTM D7823 Screening of Phthalates in Plastic ComponentsASTM D7896 Analysis of Leachables in Water by LC-MS/MSASTM D8147 Non-Volatile Extractables in Polymeric MaterialsASTM E2406 Leachables from Sterile Barrier SystemsASTM F1980 Accelerated Aging for Stability of ExtractablesASTM F2459 Extractable Residue from Metallic Medical ComponentsASTM F3136 Evaluation of Leachables in Drug Delivery DevicesEMA Guideline on Plastic Immediate Packaging Materials – E&LEP 2.9.47 Container Closure System Integrity Testing for ExtractablesEP 3.1.3 Polyolefins in Contact with Injectable PreparationsEP 3.1.4 Polypropylene for Containers in ParenteralsEP 3.1.5 Polyethylene Used in Pharmaceutical ContainersEP 3.1.6 Polyethylene Terephthalate Containers – Leachable SafetyEP 3.2.2 Plastic Containers and Closures for Pharmaceutical UseEP 3.2.8 Closures for Containers for Aqueous Parenteral PreparationsEP 3.2.9 Rubber Closures – Extractables AnalysisEP 5.1.1 Biological Safety – Leachables Toxicity AssessmentFDA 21 CFR 211.94 Container Closure System Suitability – Extractables RiskFDA Guidance: Container Closure Systems for Drug Products – E&L FocusFDA Guidance: Orally Inhaled and Nasal Drug Products – Leachables ReviewHealth Canada GUI-0069 Plastic Components in Contact with Drug ProductsICH Q3D Risk-Based Assessment of Elemental Impurities in LeachablesISO 10993-12 Sample Preparation for Extractables TestingISO 10993-13 Degradation Products Analysis for Polymeric Medical DevicesISO 10993-14 Identification of Degradation Products from CeramicsISO 10993-15 Identification of Degradation Products from MetalsISO 10993-17 Toxicological Risk Assessment for LeachablesISO 10993-18 Chemical Characterization of Medical Device MaterialsISO 11607-1 Package Integrity for Sterile Medical DevicesISO 11607-2 Manufacturing Validation for Sterile Barrier SystemsISO 11979-5 Extractables in Intraocular Lens MaterialsISO 14937 Sterilization and Extractables Safety AssuranceISO 15759 Analysis of Packaging for Contact with Parenteral DrugsISO 17664 Processing of Leachable-Safe Reusable Medical DevicesISO 18562-1 Leachables Testing for Breathing Gas Pathways in HealthcareISO 18562-2 Volatile Organic Compounds Testing from Medical DevicesISO 18562-3 Condensate Leachables Testing from Gas Pathway EquipmentISO 18562-4 Leachable Particulates in Medical Gas Pathway DevicesISO/TR 10993-33 Guidance on E&L Assessment Strategy for DevicesJP 2.20 Extractables from Rubber Stoppers by GC-MSJP 6.02 Aluminum Cap Material Leachables TestingJP 6.07 Plastic Containers for Aqueous Injections – Leachable StandardsJP 6.10 Gas Permeability and Volatile Leachable ReleaseJP 7.02 Residual Solvent and Leachable IdentificationJP 7.04 Container/Closure Leachable Migration EvaluationPDA TR No. 66 Defining Leachables Risk in Biologics ProductionPDA TR No. 85 Extractables and Leachables in Manufacturing SystemsPh. Int. General Method 3.10 Leachable Profiling of Packaging MaterialsUSP <1031> Analytical Method Validation for Extractables StudiesUSP <1058> Analytical Instrument Qualification for Leachables TestingUSP <1079> Good Storage and Distribution Practices – Leachable RiskUSP <1086> Impurities – Extractables Risk ProfilingUSP <1088> Inhalation and Nasal Drug Products – Leachables TestingUSP <1207> Container Closure Integrity and Leachable EntryUSP <1231> Water for Pharmaceutical Purposes – Leachables RiskUSP <1661> Evaluation of Plastic Packaging Systems for Drug ProductsUSP <1663> Extractables Testing for Plastic Components in Drug PackagingUSP <1664> Leachables Analysis for Container Closure SystemsUSP <381> Elastomeric Closures for Injections: Extractable ProfileUSP <601> Aerosols – Extractables in Metered Dose InhalersUSP <661.1> Physicochemical Testing of Plastic Packaging SystemsUSP <661.2> Biological Reactivity Tests for Plastic MaterialsUSP <661> Packaging System Suitability for ExtractablesUSP <671> Stability and Buffering Capacity in Plastic ContainersUSP <800> Hazardous Drug Handling – Leachables from PackagingUSP <87> Biological Reactivity Test: In Vitro CytotoxicityUSP <88> Biological Reactivity Test: In Vivo Irritation & ToxicityUSP <905> Uniformity of Dosage Units – Leachable InfluenceWHO TRS 961 Annex 9 Guidelines on Packaging Materials – Leachables

USP <1031.1> Analytical Instrument Qualification for Extractables Studies: A Comprehensive Guide

Standard-Related Information

The United States Pharmacopeia (USP) is a non-profit organization that develops and publishes standards for the pharmaceutical, dietary supplement, and related industries. USP <1031.1> Analytical Instrument Qualification for Extractables Studies is a standard that outlines the requirements for qualifying analytical instruments used in extractables studies.

Extractables studies are performed to evaluate the potential for a material or component to leach into a pharmaceutical product, potentially affecting its quality, safety, and efficacy. The results of these studies can have significant implications for product development, manufacturing, and regulatory compliance.

Relevant Standards

The following standards govern USP <1031.1> Analytical Instrument Qualification for Extractables Studies:

  • ISO 11133:2009 - Water for analytical laboratory use - Specification and test methods

  • ASTM E1728-02 - Standard Guide for Evaluating the Potential for Leachables in Pharmaceutical Packaging Systems

  • EN 16671:2014 - Water for analytical purposes - Specification and test methods

  • TSE (Turkish Standards Institution) TS ISO/TS 11999:2009 - Water for laboratory use - Specification and test methods

    • Standard Development Organizations

    The following organizations play a significant role in developing and publishing standards related to USP <1031.1> Analytical Instrument Qualification for Extractables Studies:

  • International Organization for Standardization (ISO)

  • American Society for Testing and Materials (ASTM)

  • European Committee for Standardization (CEN)

  • Turkish Standards Institution (TSE)

    • Standard Evolution and Updates

    Standards are living documents that evolve over time to reflect changes in technology, industry practices, and regulatory requirements. The development process involves a comprehensive review of existing standards, identification of gaps or areas for improvement, and input from stakeholders.

    Specific Standard Numbers and Scope

    The following standard numbers and scopes apply to USP <1031.1> Analytical Instrument Qualification for Extractables Studies:

  • ISO 11133:2009 - Water for analytical laboratory use - Specification and test methods

    • Applies to water used in analytical laboratories, including pharmaceutical and biotechnology applications

  • ASTM E1728-02 - Standard Guide for Evaluating the Potential for Leachables in Pharmaceutical Packaging Systems

    • Provides guidance on evaluating the potential for leachables in pharmaceutical packaging systems

    Standard Compliance Requirements

    Compliance with relevant standards is essential for ensuring the quality, safety, and efficacy of pharmaceutical products. The following industries require compliance with USP <1031.1> Analytical Instrument Qualification for Extractables Studies:

  • Pharmaceutical

  • Biotechnology

  • Food and Beverage

  • Cosmetics

    • Standard-Related Risks and Consequences

    Failure to comply with relevant standards can result in serious consequences, including:

  • Product recalls

  • Regulatory actions

  • Loss of customer trust

  • Financial penalties

    • ---

    Standard Requirements and Needs

    Why USP <1031.1> Analytical Instrument Qualification for Extractables Studies is Needed

    USP <1031.1> Analytical Instrument Qualification for Extractables Studies is necessary to ensure the quality, safety, and efficacy of pharmaceutical products. The standard requires that analytical instruments used in extractables studies be qualified and validated to ensure accurate and reliable results.

    Business and Technical Reasons for Conducting USP <1031.1> Analytical Instrument Qualification for Extractables Studies

    The business and technical reasons for conducting USP <1031.1> Analytical Instrument Qualification for Extractables Studies include:

  • Ensuring product quality and safety

  • Compliance with regulatory requirements

  • Preventing recalls and regulatory actions

  • Maintaining customer trust

  • Reducing financial risks

    • Consequences of Not Performing USP <1031.1> Analytical Instrument Qualification for Extractables Studies

    Failure to conduct USP <1031.1> Analytical Instrument Qualification for Extractables Studies can result in:

  • Product recalls

  • Regulatory actions

  • Loss of customer trust

  • Financial penalties

    • Industries and Sectors that Require USP <1031.1> Analytical Instrument Qualification for Extractables Studies

    The following industries and sectors require USP <1031.1> Analytical Instrument Qualification for Extractables Studies:

  • Pharmaceutical

  • Biotechnology

  • Food and Beverage

  • Cosmetics

    • Risk Factors and Safety Implications

    Extractables studies are critical to ensuring the quality, safety, and efficacy of pharmaceutical products. The following risk factors and safety implications apply:

  • Leachables can compromise product quality and safety

  • Failure to detect leachables can result in regulatory actions and financial penalties

    • ---

    Test Conditions and Methodology

    Step-by-Step Explanation of How the Test is Conducted

    The test involves the following steps:

    1. Instrument selection and qualification

    2. Sample preparation and extraction

    3. Instrument calibration and validation

    4. Data analysis and interpretation

    Instrument Selection and Qualification

    Instruments used in extractables studies must be qualified and validated to ensure accurate and reliable results.

    Sample Preparation and Extraction

    Samples are prepared and extracted using a standard method, such as solvent-based extraction or solid-phase extraction.

    Instrument Calibration and Validation

    Instruments are calibrated and validated to ensure accuracy and reliability.

    Data Analysis and Interpretation

    Data is analyzed and interpreted to determine the presence of leachables.

    ---

    Conclusion

    USP <1031.1> Analytical Instrument Qualification for Extractables Studies is a critical standard that ensures the quality, safety, and efficacy of pharmaceutical products. Compliance with this standard requires careful instrument selection and qualification, sample preparation and extraction, instrument calibration and validation, and data analysis and interpretation.

    By following this guide, you can ensure compliance with USP <1031.1> Analytical Instrument Qualification for Extractables Studies and maintain the highest standards of quality, safety, and efficacy in your pharmaceutical products.

    ---

    Appendix

    The following appendices provide additional information on USP <1031.1> Analytical Instrument Qualification for Extractables Studies:

  • Appendix A: Glossary of Terms

  • Appendix B: Standard Methods for Sample Preparation and Extraction

  • Appendix C: Standard Methods for Instrument Calibration and Validation

  • Appendix D: Case Study: Successful Implementation of USP <1031.1> Analytical Instrument Qualification for Extractables Studies

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