EUROLAB
ph-eur-510-control-of-impurities-in-substances-for-pharmaceutical-use
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 10993-18: Chemical Characterization and Impurity AnalysisISO 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. 5.4: 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 Ph. Eur. 5.10: Control of Impurities in Substances for Pharmaceutical Use Laboratory Testing Service Provided by Eurolab

Pharmacopeial Forum, Volume 5(10), 2019 provides the framework for testing and controlling impurities in substances used in pharmaceutical products. The European Pharmacopoeia (Ph. Eur.) is a collection of standards that govern the quality, safety, and efficacy of medicinal products. Ph. Eur. 5.10: Control of Impurities in Substances for Pharmaceutical Use is one such standard that outlines the requirements for testing impurities in substances used in pharmaceutical production.

Relevant Standards

  • ISO/IEC 17025 (General Requirements for the Competence of Testing and Calibration Laboratories)

  • ASTM E2580-11 (Standard Practice for Conducting an Interlaboratory Study to Evaluate the Performance of a Chemical Test Method)

  • EN ISO/IEC 17020 (Conformity Assessment -- Requirements for the Operation of Various Types of Bodies Performing Inspection)

    • International and National Standards

    The Ph. Eur. 5.10 standard is based on international standards, including:

  • International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Q3A(R2): Impurities: Guiding Principles

  • ICH Q3B(R2): Impurities in New Drug Substances

    • National standards that apply to this testing service include:

  • USP <232>: Elemental Impurities -- Limits

  • EP 5.10: Control of Impurities in Substances for Pharmaceutical Use

    • Standard Development Organizations

    The European Pharmacopoeia Commission is responsible for developing and maintaining the Ph. Eur. standards, including Ph. Eur. 5.10. Other standard development organizations that contribute to this testing service include:

  • International Organization for Standardization (ISO)

  • American Society for Testing and Materials (ASTM)

    • Standard Evolution and Updates

    Standards evolve over time as new technologies and methodologies emerge. The Ph. Eur. Commission regularly reviews and updates standards, including Ph. Eur. 5.10, to ensure they remain relevant and effective.

    Compliance Requirements

    Companies in the pharmaceutical industry must comply with Ph. Eur. 5.10 when testing for impurities in substances used in production. Compliance is essential to ensure product safety and efficacy.

    Industry-Specific Examples and Case Studies

    The pharma industry has a long history of relying on laboratory testing services like Eurolabs Ph. Eur. 5.10: Control of Impurities in Substances for Pharmaceutical Use service. Companies such as Pfizer, Merck Co., Inc., and GlaxoSmithKline have successfully implemented this standard to ensure the quality of their products.

    Ph. Eur. 5.10: Control of Impurities in Substances for Pharmaceutical Use is a critical testing service that ensures the quality, safety, and efficacy of pharmaceutical products. This standard requires companies to test substances used in production for impurities, which can affect product performance.

    Business and Technical Reasons

    The primary business reason for conducting Ph. Eur. 5.10: Control of Impurities in Substances for Pharmaceutical Use testing is to ensure compliance with regulatory requirements. Companies must demonstrate that their products meet the required standards to avoid costly recalls, lawsuits, or reputational damage.

    The technical reasons for this testing service are equally important:

  • Impurities can affect product performance and efficacy

  • Ensuring product safety and quality

  • Compliance with regulatory requirements

    • Consequences of Not Performing This Test

    Failure to conduct Ph. Eur. 5.10: Control of Impurities in Substances for Pharmaceutical Use testing can result in significant consequences, including:

  • Product recalls or withdrawals

  • Reputational damage and loss of customer trust

  • Regulatory fines or penalties

  • Decreased market share and revenue

    • Risk Factors and Safety Implications

    Impurities in substances used in pharmaceutical production can have serious safety implications, including:

  • Reduced product efficacy

  • Increased risk of adverse reactions

  • Potential for toxicological effects

    • Ph. Eur. 5.10: Control of Impurities in Substances for Pharmaceutical Use testing helps mitigate these risks by ensuring the quality and purity of substances used in production.

    Quality Assurance and Quality Control

    Companies must ensure that their laboratory testing services, like Eurolabs Ph. Eur. 5.10: Control of Impurities in Substances for Pharmaceutical Use service, adhere to strict quality assurance (QA) and quality control (QC) procedures.

    Ph. Eur. 5.10: Control of Impurities in Substances for Pharmaceutical Use testing requires precise methodology and equipment to ensure accurate results.

    Laboratory Equipment and Software

    Eurolabs Ph. Eur. 5.10: Control of Impurities in Substances for Pharmaceutical Use service utilizes state-of-the-art laboratory equipment, including:

  • High-performance liquid chromatography (HPLC) systems

  • Mass spectrometry (MS) instruments

  • Automatic sampling and injection systems

    • Testing Procedure

    The testing procedure involves the following steps:

    1. Sample preparation

    2. Chromatographic analysis

    3. Data processing and interpretation

    4. Reporting results

    Data Validation and Quality Control

    Eurolabs Ph. Eur. 5.10: Control of Impurities in Substances for Pharmaceutical Use service implements rigorous data validation and quality control procedures to ensure the accuracy and reliability of test results.

    Reporting Results

    Results from Ph. Eur. 5.10: Control of Impurities in Substances for Pharmaceutical Use testing are reported according to Ph. Eur. guidelines, including:

  • Identification of impurities

  • Quantification of impurities

  • Compliance with regulatory requirements

    • Test Validation and Calibration

    Eurolabs Ph. Eur. 5.10: Control of Impurities in Substances for Pharmaceutical Use service maintains strict test validation and calibration procedures to ensure the accuracy and reliability of test results.

    Reporting Requirements

    Companies must report results from Ph. Eur. 5.10: Control of Impurities in Substances for Pharmaceutical Use testing according to regulatory requirements, including:

  • EP 2.1: Validation of Analytical Procedures

  • USP <1223>: Validation of Compendial Methods

    • Ph. Eur. 5.10: Control of Impurities in Substances for Pharmaceutical Use is a critical standard that ensures the quality, safety, and efficacy of pharmaceutical products. Eurolabs Ph. Eur. 5.10: Control of Impurities in Substances for Pharmaceutical Use service provides a comprehensive testing solution to meet regulatory requirements.

    Appendix

    The following is an example of a laboratory report from Eurolabs Ph. Eur. 5.10: Control of Impurities in Substances for Pharmaceutical Use service:

    Substance Detection Limit (mg/kg) Quantification Limit (mg/kg) Result

    --- --- --- ---

    A 0.1 0.2 Not detected

    B 0.5 1.0 Detected at 0.6 mg/kg

    This report demonstrates the importance of Ph. Eur. 5.10: Control of Impurities in Substances for Pharmaceutical Use testing in ensuring product quality and safety.

    References

    1. European Pharmacopoeia Commission (2019). Ph. Eur. 5.10: Control of Impurities in Substances for Pharmaceutical Use.

    2. International Organization for Standardization (ISO) (2020). ISO/IEC 17025: General Requirements for the Competence of Testing and Calibration Laboratories.

    3. American Society for Testing and Materials (ASTM) (2011). ASTM E2580-11: Standard Practice for Conducting an Interlaboratory Study to Evaluate the Performance of a Chemical Test Method.

    Acknowledgments

    The authors would like to thank Eurolabs Ph. Eur. 5.10: Control of Impurities in Substances for Pharmaceutical Use service team for their expertise and contributions to this comprehensive guide.

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