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usp-905-uniformity-of-dosage-units-leachable-influence
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 <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 & ToxicityWHO TRS 961 Annex 9 Guidelines on Packaging Materials – Leachables

USP <905> Uniformity of Dosage Units Leachable Influence Laboratory Testing Service: A Comprehensive Guide

The Uniformity of Dosage Units Leachable Influence test is governed by the United States Pharmacopeia (USP) <905> standard. This standard outlines the requirements for testing the leachable influence of dosage units, which are critical to ensuring the safety and efficacy of pharmaceutical products.

International and National Standards

  • ISO 2859-1:2017: Sampling procedures for inspection by attributes

  • ASTM E2535-17: Standard Practice for Leachables and Extractables Testing of Pharmaceutical Packaging Materials

  • EN 1663:2006: Sampling and sampling plan for inspection by attributes

  • TSE 1552:2014: Turkish Standards Institution Uniformity of Dosage Units

    • Standard Development Organizations

    The International Organization for Standardization (ISO) is responsible for the development and maintenance of international standards. The American Society for Testing and Materials (ASTM) and the European Committee for Standardization (CEN) are also involved in standard development.

    Evolution and Updates

    Standards evolve and get updated to reflect new scientific knowledge, technological advancements, and changing regulatory requirements. The USP <905> standard has undergone several revisions since its inception.

    Standard Numbers and Scope

  • USP <905>: Uniformity of Dosage Units Leachable Influence

  • ISO 2859-1:2017: Sampling procedures for inspection by attributes

  • ASTM E2535-17: Standard Practice for Leachables and Extractables Testing of Pharmaceutical Packaging Materials

    • Compliance Requirements

    Pharmaceutical companies must comply with the USP <905> standard to ensure the safety and efficacy of their products. This involves conducting regular testing and maintaining accurate records.

    The USP <905> standard requires manufacturers to test for leachable influence in dosage units, including tablets, capsules, and vials. Leachables are chemical substances that can migrate from packaging materials into the product, potentially affecting its quality or safety.

    Why This Test Is Needed

    The Uniformity of Dosage Units Leachable Influence test is essential for ensuring the safety and efficacy of pharmaceutical products. Leachables can have a significant impact on product quality and patient health, making this testing critical.

    Business and Technical Reasons

  • Ensure compliance with regulatory requirements

  • Protect patients from potential harm

  • Maintain product quality and integrity

  • Enhance reputation and credibility

    • Consequences of Not Performing This Test

    Failure to conduct the Uniformity of Dosage Units Leachable Influence test can result in:

  • Regulatory non-compliance

  • Product recalls or withdrawals

  • Damage to reputation and credibility

  • Financial losses due to litigation or settlements

    • Industries and Sectors That Require This Testing

    Pharmaceutical companies, contract manufacturers, and packaging suppliers must conduct the Uniformity of Dosage Units Leachable Influence test.

    Risk Factors and Safety Implications

    Leachables can have a significant impact on product safety and efficacy. Failure to detect leachables can lead to adverse reactions or even fatalities.

    Quality Assurance and Quality Control Aspects

    The Uniformity of Dosage Units Leachable Influence test is an essential component of quality assurance and control programs. Regular testing helps ensure compliance with regulatory requirements and maintains product integrity.

    Contribution to Product Safety and Reliability

    This testing contributes to product safety and reliability by detecting leachables that could compromise product quality or patient health.

    Competitive Advantages

    Companies that conduct the Uniformity of Dosage Units Leachable Influence test can differentiate themselves from competitors, enhancing their reputation and credibility.

    Cost-Benefit Analysis

    The benefits of conducting this testing far outweigh the costs. Regular testing ensures compliance with regulatory requirements, protects patients, and maintains product integrity.

    Step-by-Step Explanation of the Test

    1. Sample selection and preparation

    2. Leachable extraction

    3. Chromatographic analysis

    4. Data collection and reporting

    Testing Equipment and Instruments

  • High-performance liquid chromatography (HPLC) system

  • Mass spectrometry (MS) detector

  • Sampling equipment and containers

    • Testing Environment Requirements

  • Temperature: 20C 5C

  • Humidity: 50 10

  • Pressure: atmospheric pressure

    • Sample Preparation Procedures

  • Sample selection and weighing

  • Container preparation and cleaning

    • Testing Parameters and Conditions

  • Leachable extraction time: 24 hours

  • Extraction solvent: water or organic solvent

  • Chromatographic separation conditions: HPLC system settings

    • Measurement and Analysis Methods

  • Chromatographic peak detection and integration

  • Mass spectrometry data analysis

    • Data Collection and Reporting

  • Raw data collection

  • Data analysis and interpretation

  • Report preparation and submission

    • The Uniformity of Dosage Units Leachable Influence test is a complex procedure that requires specialized equipment and expertise. Regular testing ensures compliance with regulatory requirements and maintains product integrity.

    Conclusion

    The Uniformity of Dosage Units Leachable Influence test is an essential component of quality assurance and control programs in the pharmaceutical industry. Regular testing ensures compliance with regulatory requirements, protects patients, and maintains product integrity. Companies that conduct this testing can differentiate themselves from competitors, enhancing their reputation and credibility.

    Persuasive Conclusion

    Dont risk non-compliance or patient safety! Conduct regular Uniformity of Dosage Units Leachable Influence testing to ensure the quality and safety of your pharmaceutical products.

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