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usp-1031-analytical-method-validation-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 <1031.1> Analytical Instrument Qualification 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> Analytical Method Validation for Extractables Studies: Eurolabs Laboratory Testing Service

Standard-Related Information

The United States Pharmacopeia (USP) is a non-profit organization that develops and publishes standards for pharmaceuticals, dietary supplements, and other healthcare products. USP <1031> Analytical Method Validation for Extractables Studies is a standard that outlines the requirements for validating analytical methods used to detect extractables in medical devices and equipment.

International Standards

  • ISO 14644-7:2013 (Cleanrooms and associated controlled environments Part 7: Separative measures)

  • ASTM E2187-08 (Standard Guide for Evaluating Extractables Associated with Pharmaceutical Packaging Materials)

  • EN 16602-5 (Medical devices Quality management systems Requirements for regulatory purposes)

    • Regulatory Framework

    The regulatory framework surrounding USP <1031> Analytical Method Validation for Extractables Studies testing is governed by national and international regulations, including:

  • FDA guidelines for medical device manufacturers

  • ISO 13485:2016 (Quality Management Systems Medical Devices Requirements for Regulatory Purposes)

  • EU MDR 2017/745 (Medical Device Regulation)

    • Standard Development Organizations

    The International Organization for Standardization (ISO), the American Society for Testing and Materials (ASTM), and the European Committee for Standardization (CEN) are responsible for developing and maintaining international standards related to USP <1031> Analytical Method Validation for Extractables Studies testing.

    Evolution of Standards

    Standards evolve through a continuous process of review, revision, and update. This ensures that they remain relevant and effective in protecting public health and safety.

    Standard Numbers and Scope

    Some relevant standard numbers and their scope include:

  • USP <1031> Analytical Method Validation for Extractables Studies

  • ISO 14644-7:2013 (Cleanrooms and associated controlled environments Part 7: Separative measures)

  • ASTM E2187-08 (Standard Guide for Evaluating Extractables Associated with Pharmaceutical Packaging Materials)

    • Industry-Specific Requirements

    Different industries have varying requirements for USP <1031> Analytical Method Validation for Extractables Studies testing. For example:

  • Medical device manufacturers must comply with FDA guidelines and ISO 13485:2016

  • Pharmaceutical companies must comply with USP <1031> and ASTM E2187-08

    • Consequences of Non-Compliance

    Failure to perform USP <1031> Analytical Method Validation for Extractables Studies testing can result in:

  • Product recalls and market withdrawals

  • Regulatory fines and penalties

  • Loss of customer trust and confidence

    • Test Conditions and Methodology

    USP <1031> Analytical Method Validation for Extractables Studies testing involves a series of steps, including:

    1. Sample preparation

    2. Testing equipment and instruments calibration

    3. Testing environment setup (temperature, humidity, pressure)

    4. Measurement and analysis methods selection

    5. Data collection and recording

    Test Reporting and Documentation

    Test results are documented and reported in accordance with USP <1031> and ISO 14644-7:2013. This includes:

  • Test report format and structure

  • Interpretation of test results

  • Certification and accreditation details

  • Traceability and documentation requirements

    • Why this Test Should be Performed

    Performing USP <1031> Analytical Method Validation for Extractables Studies testing offers numerous benefits, including:

  • Risk assessment and mitigation through testing

  • Quality assurance and compliance benefits

  • Competitive advantages and market positioning

  • Cost savings and efficiency improvements

    • Why Eurolab Should Provide this Service

    Eurolabs expertise and experience in USP <1031> Analytical Method Validation for Extractables Studies testing make them an ideal choice for laboratories. Their state-of-the-art equipment, qualified personnel, and accreditation details ensure that clients receive high-quality results.

    Additional Requirements

    To maintain confidentiality and professionalism, the following requirements must be met:

  • Company name is always Eurolab

  • No phone numbers, addresses, or contact details are included

  • No specific pricing information is mentioned

    • Target Audience

    This comprehensive guide is intended for:

  • Quality managers and engineers

  • Regulatory compliance officers

  • Business owners and decision makers

  • Technical professionals

  • Industry consultants

  • Government officials and regulators

    • Need help or have a question?
    Contact us for prompt assistance and solutions.

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