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iso-10993-18-chemical-characterization-and-impurity-analysis
Impurity Profiling EMA Guideline on Genotoxic Impurities in PharmaceuticalsEMA Reflection Paper on Low Level ImpuritiesFDA Guidance: Microbial Impurities and Endotoxin LevelsFDA Guidance: Threshold of Toxicological Concern (TTC) for ImpuritiesFDA ICH M3(R2): Impurities in Safety StudiesFDA Q&A on Impurities in Generic Drug ApplicationsFDA Q&A: Managing Impurities in Complex APIsICH E14: QT Interval Evaluation and Impurity ImpactICH M7: Mutagenic Impurity Risk AssessmentICH Q10: Pharmaceutical Quality System for Impurity ManagementICH Q11: Impurity Control Strategy in Drug Substance DevelopmentICH Q12: Lifecycle Management of Impurity Control StrategyICH Q1E: Evaluation of Stability Data Related to Impurity FormationICH Q2(R1): Validation of Analytical Methods for Impurity TestingICH Q3A: Organic Impurity Profiling in Drug SubstancesICH Q3B: Impurity Testing in Finished Drug ProductsICH Q3C: Residual Solvent ProfilingICH Q3D: Elemental Impurity Risk AssessmentICH Q3F: Impurity Guidelines for Biotechnology ProductsICH Q4B: Harmonization of Analytical Procedures for Impurity TestingICH Q5C: Impurity Monitoring in Biotechnological ProductsICH Q6A: Specifications and Acceptance Criteria for ImpuritiesICH S3A: Impurities Arising from Degradation ProductsICH S6: Biotech Product Impurity ProfilingICH S7A: Safety Pharmacology Impurity EvaluationICH S9: Impurities in Oncology ProductsISO 17025: Accreditation for Impurity Testing LaboratoriesJP General Rule 2.60: Limit Test for ImpuritiesPh. Eur. 2.2.28: Gas Chromatography for Impurity DetectionPh. Eur. 2.2.38: Thin-Layer Chromatography for ImpuritiesPh. Eur. 2.2.46: Chromatographic Separation for Impurity AnalysisPh. Eur. 2.4.14: Determination of Inorganic ImpuritiesPh. Eur. 2.4.20: Limit Test for Heavy Metals in ImpuritiesPh. Eur. 2.4.24: Related Substances by HPLC in APIsPh. Eur. 2.4.29: Limit Test for Sulfated Ash ImpuritiesPh. Eur. 2.5.13: Oxidizing Impurity TestsPh. Eur. 2.9.40: Uniformity of Dosage Units and Related ImpuritiesPh. Eur. 5.10: Control of Impurities in Substances for Pharmaceutical UsePh. Eur. 5.4: Impurities in Radiopharmaceutical PreparationsUSP <1010>: Analytical Data Integrity in Impurity ReportingUSP <1031>: The Biocompatibility of Materials and ImpuritiesUSP <1051>: Cleaning Validation Limits and Residual ImpuritiesUSP <1058>: Analytical Instrument Qualification for Impurity StudiesUSP <1078>: Good Manufacturing Practices for Impurity ReductionUSP <1085>: Evaluation of Impurity Method PerformanceUSP <1086>: Impurities in Drug SubstancesUSP <1088>: Forced Degradation Studies for Impurity CharacterizationUSP <1091>: Impurity Isolation and Characterization TechniquesUSP <1099>: Acceptable Analytical Performance CriteriaUSP <1121>: Bulk Pharmaceutical Chemicals and Impurity HandlingUSP <1151>: Pharmaceutical Dosage Forms and Impurity ConsiderationUSP <1191>: Stability Testing of Compounded PreparationsUSP <1222>: Terminal Sterilization Impact on ImpuritiesUSP <1224>: Transfer of Impurity Test ProceduresUSP <1225>: Validation of Compendial Procedures for ImpuritiesUSP <1226>: Verification of Compendial Procedures for Impurity DetectionUSP <1231>: Water for Pharmaceutical Purposes and Impurity EffectsUSP <1232>: Water Activity and Impurity StabilityUSP <1241>: Capsules and Shell Impurity InteractionUSP <1251>: Weighing on Analytical Balances for Micro-ImpuritiesUSP <161>: Transdermal Delivery Systems and Impurity ControlUSP <197>: Spectrophotometric Identification of ImpuritiesUSP <233>: Elemental Impurities Profiling Using ICP-MSUSP <41>: Balances Used for Impurity Weight DeterminationUSP <466>: Identification and Quantification of DegradantsUSP <467>: Residual Solvent Testing in APIs and ExcipientsUSP <476>: Impurity Profiling for New Drug ApplicationsUSP <621>: Chromatography Conditions for Impurity IdentificationUSP <730>: Plasma Spectrochemistry for Impurity ProfilingUSP <791>: pH Determination Impact on Impurity SolubilityUSP <797>: Sterile Compounding and Impurity ControlUSP <800>: Hazardous Drug Handling Based on Impurity RiskUSP <851>: Spectrophotometry and Light Scattering for ImpuritiesUSP <853>: Atomic Absorption Spectroscopy for Trace ImpuritiesUSP <857>: UV-Vis Spectroscopy for Impurity QuantificationUSP <85>: Bacterial Endotoxin Limits Related to Impurity SafetyUSP <891>: Nuclear Magnetic Resonance (NMR) for Structural ElucidationUSP <905>: Content Uniformity Related to ImpuritiesUSP <905>: Uniformity of Dosage Units Affected by ImpuritiesUSP <941>: Characterization of Impurity Solubility and pKaWHO TRS 970 Annex 2: Impurity Control in Medicines

Comprehensive Guide to ISO 10993-18: Chemical Characterization and Impurity Analysis Testing Services Provided by Eurolab

ISO 10993-18 is a standard developed by the International Organization for Standardization (ISO) that specifies requirements for the chemical characterization and impurity analysis of medical devices. The standard is part of the ISO 10993 series, which provides guidelines for the biological evaluation of medical devices.

Legal and Regulatory Framework

The legal and regulatory framework surrounding ISO 10993-18: Chemical Characterization and Impurity Analysis testing is governed by various international and national standards. Some of the key regulations include:

  • EU Medical Device Regulation (MDR) 2017/745

  • FDA Guidance for Industry: ISO 10993-1, Cytotoxicity of Materials in Contact with Blood

  • USP <467> Elemental Impurities - Limits

    • International and National Standards

    The following standards are applicable to ISO 10993-18: Chemical Characterization and Impurity Analysis testing:

  • ISO 10993-1: Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process

  • ASTM F748-07: Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices

  • EN 14295:2015A1:2020 Medical face masks - Requirements and test methods

    • Standard Development Organizations

    The following organizations play a significant role in the development of standards related to ISO 10993-18:

  • International Organization for Standardization (ISO)

  • American Society for Testing and Materials (ASTM)

  • European Committee for Standardization (CEN)

    • Evolution and Updates of Standards

    Standards evolve over time to reflect new scientific knowledge, technological advancements, and changing regulatory requirements. Regular updates ensure that standards remain relevant and effective in ensuring product safety and reliability.

    Standard Numbers and Scope

    The following standard numbers and scope are relevant to ISO 10993-18:

  • ISO 10993-1: Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process

  • ISO 10993-2: Biological evaluation of medical devices Part 2: Sample preparation, extraction, clean-up, separation, identification and quantification of identified starting materials and potential impurities

  • ASTM F748-07: Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices

    • Standard Compliance Requirements

    Compliance with ISO 10993-18 is mandatory for medical device manufacturers who intend to market their products in the European Union, United States, or other countries that recognize this standard.

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    Why This Test is Needed and Required

    ISO 10993-18: Chemical Characterization and Impurity Analysis testing is essential for ensuring product safety and reliability. The test helps to identify potential impurities in medical devices, which can cause harm to patients.

    Business and Technical Reasons for Conducting the Test

    The business and technical reasons for conducting ISO 10993-18: Chemical Characterization and Impurity Analysis testing include:

  • Ensuring compliance with regulatory requirements

  • Protecting patient safety and health

  • Maintaining product quality and reliability

  • Enhancing brand reputation and customer confidence

    • Consequences of Not Performing the Test

    Failure to conduct ISO 10993-18: Chemical Characterization and Impurity Analysis testing can result in:

  • Regulatory non-compliance

  • Product recall or withdrawal from the market

  • Damage to brand reputation and customer trust

  • Financial losses due to product liability claims

    • Industries and Sectors that Require This Testing

    Medical device manufacturers, including those producing implants, surgical instruments, and diagnostic equipment, require ISO 10993-18: Chemical Characterization and Impurity Analysis testing.

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    Testing Equipment and Instruments Used

    The following equipment and instruments are used in ISO 10993-18: Chemical Characterization and Impurity Analysis testing:

  • Gas chromatography-mass spectrometry (GC-MS)

  • Liquid chromatography-tandem mass spectrometry (LC-MS/MS)

  • Inductively coupled plasma mass spectrometry (ICP-MS)

    • Testing Environment Requirements

    The following testing environment requirements are necessary for ISO 10993-18: Chemical Characterization and Impurity Analysis testing:

  • Temperature range of 20C to 25C

  • Relative humidity of 50 to 60

  • Atmosphere with no drafts or vibrations

    • Sample Preparation Procedures

    Sample preparation involves the following steps:

    1. Sample collection and storage

    2. Extraction and clean-up

    3. Separation, identification, and quantification of starting materials and potential impurities

    Testing Parameters and Conditions

    The following testing parameters and conditions are applicable to ISO 10993-18: Chemical Characterization and Impurity Analysis testing:

  • Temperature (e.g., 20C to 25C)

  • Pressure (e.g., atmospheric pressure)

  • Flow rate (e.g., 1.0 mL/min)

    • Identification and Quantification of Starting Materials and Potential Impurities

    The following methods are used for identification and quantification:

  • Gas chromatography-mass spectrometry (GC-MS)

  • Liquid chromatography-tandem mass spectrometry (LC-MS/MS)

  • Inductively coupled plasma mass spectrometry (ICP-MS)

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    Conclusion

    ISO 10993-18: Chemical Characterization and Impurity Analysis testing is essential for ensuring product safety and reliability in the medical device industry. Compliance with this standard is mandatory for manufacturers who intend to market their products in regulated markets.

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    Compliance and Regulatory Requirements

    Compliance with ISO 10993-18 requires:

  • Regular audits and assessments

  • Implementation of corrective actions as necessary

  • Maintenance of records and documentation

    • Certification and Accreditation

    Eurolab offers certification and accreditation services for medical device manufacturers who require ISO 10993-18: Chemical Characterization and Impurity Analysis testing.

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    Contact Us

    For more information about ISO 10993-18: Chemical Characterization and Impurity Analysis testing, please contact us at infoeurolab.com(mailto:infoeurolab.com) or 1 (800) 123-4567.

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