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usp-1231-water-for-pharmaceutical-purposes-leachables-risk
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 <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 <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 <1231> Water for Pharmaceutical Purposes Leachables Risk Laboratory Testing Service

Provided by Eurolab: A Comprehensive Guide

Table of Contents

1. Standard-Related Information(standard-related-information)

1.1 Overview of Standards Governing USP <1231>

1.2 Legal and Regulatory Framework

1.3 International and National Standards

1.4 Standard Development Organizations and Their Role

1.5 Evolution of Standards and Updates

2. Standard Requirements and Needs(standard-requirements-and-needs)

2.1 Business and Technical Reasons for Conducting USP <1231>

2.2 Consequences of Not Performing this Test

2.3 Industries Requiring this Testing

2.4 Risk Factors and Safety Implications

3. Test Conditions and Methodology(test-conditions-and-methodology)

3.1 Detailed Step-by-Step Explanation of the Test

3.2 Equipment and Instruments Used

3.3 Testing Environment Requirements

3.4 Sample Preparation Procedures

3.5 Measurement and Analysis Methods

4. Test Reporting and Documentation(test-reporting-and-documentation)

4.1 Documenting Test Results and Reporting

4.2 Report Format and Structure

4.3 Interpretation of Test Results

5. Why this Test Should be Performed(why-this-test-should-be-performed)

5.1 Benefits and Advantages of Conducting USP <1231>

5.2 Risk Assessment and Mitigation through Testing

6. Why Eurolab Should Provide this Service(why-eurolab-should-provide-this-service)

6.1 Eurolabs Expertise and Experience in this Field

Standard-Related Information

Overview of Standards Governing USP <1231>

The United States Pharmacopeia (USP) <1231> Water for Pharmaceutical Purposes Leachables Risk laboratory testing service is governed by a set of international and national standards. These standards ensure that the test results are accurate, reliable, and compliant with regulatory requirements.

Legal and Regulatory Framework

The legal and regulatory framework surrounding USP <1231> is based on various laws and regulations. Some key legislation includes:

  • United States Pharmacopeia (USP) Chapter <1231>

  • International Conference on Harmonisation (ICH)

  • Good Manufacturing Practice (GMP)

    • International and National Standards

    The following international and national standards apply to USP <1231> laboratory testing:

  • ISO 11133:2009(E)

  • ASTM D5156-07

  • EN 14252-2012A1:2014

    • Standard Development Organizations and Their Role

    Standard development organizations (SDOs) play a crucial role in developing, maintaining, and revising standards. Some key SDOs involved in the development of USP <1231> include:

  • International Organization for Standardization (ISO)

  • American Society for Testing and Materials (ASTM)

  • European Committee for Standardization (CEN)

    • Evolution of Standards and Updates

    Standards are constantly evolving to reflect advancements in technology, changes in regulatory requirements, and improvements in testing methodologies. It is essential to stay up-to-date with the latest standards and updates to ensure compliance.

    Standard Requirements and Needs

    Business and Technical Reasons for Conducting USP <1231>

    The business and technical reasons for conducting USP <1231> laboratory testing include:

  • Ensuring product safety and reliability

  • Meeting regulatory requirements

  • Complying with industry standards

  • Maintaining customer trust and confidence

    • Consequences of Not Performing this Test

    Failure to conduct USP <1231> laboratory testing can result in:

  • Product recalls

  • Loss of market share

  • Damage to reputation

  • Financial penalties

    • Test Conditions and Methodology

    Detailed Step-by-Step Explanation of the Test

    The USP <1231> Water for Pharmaceutical Purposes Leachables Risk laboratory testing service involves the following steps:

    1. Sample preparation

    2. Testing

    3. Measurement and analysis

    4. Data collection and recording

    5. Reporting

    Equipment and Instruments Used

    Eurolab uses state-of-the-art equipment and instruments, including:

  • High-performance liquid chromatography (HPLC)

  • Gas chromatography-mass spectrometry (GC-MS)

  • Inductively coupled plasma mass spectrometry (ICP-MS)

    • Test Reporting and Documentation

    Documenting Test Results and Reporting

    Eurolab provides comprehensive test reports, including:

  • Detailed descriptions of the testing procedure

  • Raw data

  • Calculated results

  • Conclusion and recommendations

    • Report Format and Structure

    Our reports are formatted according to industry standards, ensuring clarity and ease of understanding.

    Why this Test Should be Performed

    Benefits and Advantages of Conducting USP <1231>

    The benefits of conducting USP <1231> laboratory testing include:

  • Ensuring product safety and reliability

  • Meeting regulatory requirements

  • Complying with industry standards

  • Maintaining customer trust and confidence

    • Why Eurolab Should Provide this Service

    Eurolabs Expertise and Experience in this Field

    Eurolab has extensive expertise and experience in providing USP <1231> Water for Pharmaceutical Purposes Leachables Risk laboratory testing services. Our team of skilled professionals ensures accurate, reliable, and compliant test results.

    Conclusion

    In conclusion, the USP <1231> Water for Pharmaceutical Purposes Leachables Risk laboratory testing service is a critical component of ensuring product safety and reliability. Eurolabs expertise and experience in this field make us an ideal partner for companies seeking to conduct this testing. Contact us today to learn more about our services.

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    About Eurolab

    Eurolab is a leading provider of laboratory testing services, specializing in USP <1231> Water for Pharmaceutical Purposes Leachables Risk testing. Our team of skilled professionals ensures accurate, reliable, and compliant test results. With extensive expertise and experience in this field, we are committed to delivering high-quality services that meet the needs of our clients.

    Contact Us

    For more information about Eurolabs USP <1231> Water for Pharmaceutical Purposes Leachables Risk laboratory testing services, please contact us at:

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    We look forward to partnering with you!

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