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astm-d7896-analysis-of-leachables-in-water-by-lc-msms
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 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 <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

ASTM D7896 Analysis of Leachables in Water by LC-MS/MS: A Comprehensive Guide to Laboratory Testing Services

The analysis of leachables in water by Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS) is a critical testing service for ensuring the safety and quality of various products, including pharmaceuticals, medical devices, and consumer goods. The American Society for Testing and Materials (ASTM) Standard D7896 provides guidelines for this testing method.

Legal and Regulatory Framework

The testing of leachables in water by LC-MS/MS is governed by various international and national standards, including ASTM D7896, ISO 16570, EN 16638, TSE 1323, and others. These standards ensure that products meet specific regulatory requirements for safety, quality, and environmental protection.

Standard Development Organizations

The development of standards for leachable testing is carried out by organizations such as the International Organization for Standardization (ISO), ASTM, and the European Committee for Standardization (CEN). These organizations work collaboratively to establish common practices and methods for ensuring product safety and quality.

Evolution of Standards

Standards evolve over time as new technologies, methods, and regulations emerge. Regular updates ensure that testing services remain compliant with changing regulatory requirements.

Standard Numbers and Scope

  • ASTM D7896: Standard Practice for Analysis of Leachables in Water by Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS)

  • ISO 16570: Pharmaceuticals -- Determination of leachable substances from plastic packaging materials

  • EN 16638: Packaging - Requirements for the determination of volatile organic compounds (VOCs) and semi-volatile organic compounds (SVOCs) in plastics

    • Compliance Requirements

    Regulatory compliance is essential for various industries, including pharmaceuticals, medical devices, cosmetics, and consumer goods. Compliance with standards such as ASTM D7896 ensures that products meet safety, quality, and environmental protection requirements.

    Standard-Related Information Table

    Standard Title Scope

    --- --- ---

    ASTM D7896 Analysis of Leachables in Water by LC-MS/MS Testing method for leachable substances in water using LC-MS/MS

    ISO 16570 Pharmaceuticals -- Determination of leachable substances from plastic packaging materials Testing method for leachable substances in pharmaceutical packaging materials

    EN 16638 Packaging - Requirements for the determination of volatile organic compounds (VOCs) and semi-volatile organic compounds (SVOCs) in plastics Testing requirements for VOCs and SVOCs in plastic packaging materials

    The analysis of leachables in water by LC-MS/MS is a critical testing service that ensures product safety, quality, and regulatory compliance. This section explains the business and technical reasons for conducting this test.

    Consequences of Not Performing the Test

    Failure to conduct ASTM D7896 Analysis of Leachables in Water by LC-MS/MS testing can lead to:

  • Product recalls and reputational damage

  • Regulatory non-compliance and fines

  • Safety risks for consumers and users

  • Loss of market share and revenue

    • Industries Requiring This Testing

    The following industries require ASTM D7896 Analysis of Leachables in Water by LC-MS/MS testing:

  • Pharmaceuticals and biopharmaceuticals

  • Medical devices and equipment

  • Cosmetics and personal care products

  • Consumer goods (e.g., food packaging, baby care products)

  • Chemical and materials manufacturers

    • Risk Factors and Safety Implications

    The analysis of leachables in water by LC-MS/MS identifies potential risks to human health and safety. These include:

  • Exposure to toxic substances through leachable chemicals

  • Contamination of products with hazardous materials

  • Inadequate labeling or warnings regarding potential hazards

    • Quality Assurance and Quality Control Aspects

    Eurolabs testing services adhere to rigorous quality assurance and quality control measures, ensuring the accuracy, reliability, and compliance of test results.

    Contribution to Product Safety and Reliability

    The analysis of leachables in water by LC-MS/MS contributes significantly to product safety and reliability by:

  • Identifying potential hazards and risks

  • Ensuring regulatory compliance

  • Enhancing consumer confidence and trust

    • Competitive Advantages and Cost-Benefit Analysis

    Conducting ASTM D7896 Analysis of Leachables in Water by LC-MS/MS testing provides significant competitive advantages, including:

  • Compliance with regulations and industry standards

  • Enhanced product safety and reliability

  • Improved customer confidence and loyalty

  • Reduced risk of product recalls and reputational damage

    • This section outlines the test conditions and methodology for ASTM D7896 Analysis of Leachables in Water by LC-MS/MS.

    Test Equipment and Materials

    The following equipment and materials are required for the analysis of leachables in water by LC-MS/MS:

  • Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS) instrument

  • Sample preparation equipment (e.g., centrifuge, pipette)

  • Standards and calibration solutions

    • Sample Preparation

    The following steps are involved in preparing samples for analysis:

    1. Collection of water samples from product packaging materials or manufacturing processes.

    2. Centrifugation to separate particles from the aqueous phase.

    3. Filtration to remove contaminants.

    4. Preparation of standards and calibration solutions.

    Instrument Methodology

    The LC-MS/MS instrument operates according to the following methodology:

    1. Injection of sample onto a liquid chromatography column.

    2. Separation of leachable substances based on their chemical properties.

    3. Detection of leachable substances using tandem mass spectrometry (MS/MS).

    4. Quantification of leachable substances using calibration solutions and standards.

    Data Analysis and Reporting

    Eurolabs testing services include comprehensive data analysis and reporting, ensuring that test results are accurate, reliable, and compliant with regulatory requirements.

    Test Conditions Table

    Test Condition Description

    --- ---

    Sample preparation Centrifugation, filtration, standard preparation

    Instrument methodology LC-MS/MS instrument operation, calibration solutions

    Data analysis Statistical analysis, reporting

    This comprehensive guide provides a thorough understanding of ASTM D7896 Analysis of Leachables in Water by LC-MS/MS testing services. By following this guide, product manufacturers and regulatory bodies can ensure compliance with industry standards and regulations.

    Conclusion

    The analysis of leachables in water by LC-MS/MS is a critical testing service that ensures product safety, quality, and regulatory compliance. This comprehensive guide provides a thorough understanding of the standard requirements, test conditions, and methodology for ASTM D7896 Analysis of Leachables in Water by LC-MS/MS.

    References

  • ASTM D7896: Standard Practice for Analysis of Leachables in Water by Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS)

  • ISO 16570: Pharmaceuticals -- Determination of leachable substances from plastic packaging materials

  • EN 16638: Packaging - Requirements for the determination of volatile organic compounds (VOCs) and semi-volatile organic compounds (SVOCs) in plastics

    • Appendices

    The following appendices provide additional information on testing services, regulatory requirements, and industry standards:

  • Appendix A: Testing Services

  • Appendix B: Regulatory Requirements

  • Appendix C: Industry Standards

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