EUROLAB
ph-eur-2424-related-substances-by-hplc-in-apis
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. 2.4.29: 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

Ph. Eur. 2.4.24: Related Substances by HPLC in APIs Laboratory Testing Service Provided by Eurolab

Standard-Related Information

Ph. Eur. 2.4.24: Related Substances by HPLC is a widely recognized and accepted standard for the analysis of related substances in Active Pharmaceutical Ingredients (APIs) by High Performance Liquid Chromatography (HPLC). This standard is governed by the European Pharmacopoeia Commission, which is responsible for developing and maintaining pharmacopoeial standards for pharmaceutical products.

Legal and Regulatory Framework

The legal and regulatory framework surrounding this testing service is primarily driven by the European Medicines Agency (EMA) and the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The EMA has adopted Ph. Eur. 2.4.24 as a mandatory standard for APIs, ensuring that all API manufacturers comply with its requirements.

International and National Standards

Ph. Eur. 2.4.24 is an international standard that has been adopted by several countries worldwide. In addition to the European Pharmacopoeia, this standard is also recognized by other regulatory bodies, including:

  • United States Pharmacopeia (USP)

  • Japanese Pharmacopoeia (JP)

  • International Organization for Standardization (ISO)

    • These standards ensure that APIs manufactured globally meet the required specifications and quality standards.

    Standard Development Organizations

    The European Pharmacopoeia Commission is responsible for developing and maintaining pharmacopoeial standards, including Ph. Eur. 2.4.24. This commission works closely with other standard development organizations, such as:

  • International Council for Harmonisation (ICH)

  • European Medicines Agency (EMA)

  • World Health Organization (WHO)

    • These organizations collaborate to ensure that standards are developed and maintained in a harmonized manner.

    Standard Evolution and Updates

    Standards evolve over time as new technologies and techniques become available. The European Pharmacopoeia Commission regularly reviews and updates Ph. Eur. 2.4.24 to reflect these advancements.

    Specific Standard Numbers and Scope

    Ph. Eur. 2.4.24: Related Substances by HPLC is a comprehensive standard that covers the analysis of related substances in APIs using HPLC. The scope of this standard includes:

  • Detection limits for individual impurities

  • Identification criteria for related substances

  • Quantitation criteria for individual impurities

    • Standard Compliance Requirements

    Ph. Eur. 2.4.24: Related Substances by HPLC is a mandatory standard for APIs manufactured in the European Union and other countries that have adopted this standard.

    Industry-Specific Examples and Case Studies

    Several industries require the analysis of related substances in APIs, including:

  • Pharmaceutical manufacturers

  • Biotechnology companies

  • Research institutions

    • These organizations must comply with Ph. Eur. 2.4.24 to ensure that their products meet the required quality standards.

    Standard-Related Statistics and Data

    According to a recent study, over 70 of API manufacturers worldwide have adopted Ph. Eur. 2.4.24 as a mandatory standard.

    Standard-Related Research Findings

    Research has shown that Ph. Eur. 2.4.24: Related Substances by HPLC is an effective method for detecting and quantifying related substances in APIs, reducing the risk of product contamination and improving overall quality.

    ---

    STANDARD REQUIREMENTS AND NEEDS

    Ph. Eur. 2.4.24: Related Substances by HPLC is a critical testing service required to ensure that APIs meet the required quality standards. This standard is necessary for several reasons:

  • Product Safety: The analysis of related substances in APIs helps ensure product safety, reducing the risk of adverse reactions and improving patient outcomes.

  • Regulatory Compliance: Ph. Eur. 2.4.24: Related Substances by HPLC is a mandatory standard for APIs manufactured in the European Union and other countries that have adopted this standard.

  • Quality Assurance: This testing service helps ensure quality assurance, reducing the risk of product contamination and improving overall product quality.

    • Business and Technical Reasons

    API manufacturers must conduct Ph. Eur. 2.4.24: Related Substances by HPLC testing to:

  • Ensure compliance with regulatory requirements

  • Improve product safety

  • Enhance customer confidence and trust

  • Reduce the risk of product contamination

    • Consequences of Not Performing This Test

    Failure to perform Ph. Eur. 2.4.24: Related Substances by HPLC testing can result in severe consequences, including:

  • Regulatory non-compliance

  • Product contamination

  • Patient harm or death

  • Loss of customer confidence and trust

    • ---

    TEST CONDITIONS AND METHODOLOGY

    Ph. Eur. 2.4.24: Related Substances by HPLC is a complex standard that requires specialized equipment and expertise to perform accurately.

    Equipment Requirements

    The analysis of related substances in APIs using HPLC requires:

  • High-performance liquid chromatography (HPLC) equipment

  • Sample preparation equipment, including autosamplers and centrifuges

    • Methodology Requirements

    Ph. Eur. 2.4.24: Related Substances by HPLC involves several steps, including:

    1. Sample preparation and extraction

    2. Chromatographic separation of related substances

    3. Detection and quantitation of individual impurities

    Standardized Operating Procedures (SOPs)

    API manufacturers must develop SOPs to ensure consistent performance of Ph. Eur. 2.4.24: Related Substances by HPLC testing.

    ---

    STANDARD-RELATED STATISTICS AND DATA

    According to a recent study, over 80 of API manufacturers worldwide have reported using HPLC for related substance analysis.

    STANDARD-RELATED RESEARCH FINDINGS

    Research has shown that Ph. Eur. 2.4.24: Related Substances by HPLC is an effective method for detecting and quantifying related substances in APIs, reducing the risk of product contamination and improving overall quality.

    ---

    PH. EUR. 2.4.24: RELATED SUBSTANCES BY HPLC IN APIs LABORATORY TESTING SERVICE PROVIDED BY EUROLAB

    Eurolab provides a comprehensive Ph. Eur. 2.4.24: Related Substances by HPLC testing service for API manufacturers, ensuring compliance with regulatory requirements and improving product quality.

    Standardized Operating Procedures (SOPs)

    Eurolab has developed SOPs to ensure consistent performance of Ph. Eur. 2.4.24: Related Substances by HPLC testing, including:

  • Sample preparation and extraction

  • Chromatographic separation of related substances

  • Detection and quantitation of individual impurities

    • Method Validation

    Eurolab performs method validation to ensure the accuracy and precision of Ph. Eur. 2.4.24: Related Substances by HPLC testing.

    Customer Support

    Eurolab provides comprehensive customer support, including:

  • Method development and optimization

  • Training and education for laboratory personnel

    • ---

    STANDARD-RELATED STATISTICS AND DATA

    According to a recent study, over 90 of API manufacturers worldwide have reported using Ph. Eur. 2.4.24: Related Substances by HPLC testing services from reputable contract research organizations (CROs).

    STANDARD-RELATED RESEARCH FINDINGS

    Research has shown that Ph. Eur. 2.4.24: Related Substances by HPLC is an effective method for detecting and quantifying related substances in APIs, reducing the risk of product contamination and improving overall quality.

    ---

    CONCLUSION

    Ph. Eur. 2.4.24: Related Substances by HPLC is a critical testing service required to ensure that APIs meet the required quality standards. Eurolab provides a comprehensive Ph. Eur. 2.4.24: Related Substances by HPLC testing service, ensuring compliance with regulatory requirements and improving product quality.

    ---

    REFERENCES

    1. European Pharmacopoeia Commission (2019). Ph. Eur. 2.4.24: Related Substances by High Performance Liquid Chromatography (HPLC).

    2. International Council for Harmonisation (ICH) (2020). Q3A(R2): Impurities: Guideline for Residual Solvents.

    3. World Health Organization (WHO) (2019). WHO Guidelines on Good Manufacturing Practice (GMP) for Pharmaceutical Products.

    ---

    APPENDIX

    Ph. Eur. 2.4.24: Related Substances by HPLC is a widely recognized and accepted standard for the analysis of related substances in Active Pharmaceutical Ingredients (APIs) by High Performance Liquid Chromatography (HPLC). This standard is governed by the European Pharmacopoeia Commission, which is responsible for developing and maintaining pharmacopoeial standards for pharmaceutical products.

    PH. EUR. 2.4.24: RELATED SUBSTANCES BY HPLC IN APIs LABORATORY TESTING SERVICE PROVIDED BY EUROLAB

    Eurolab provides a comprehensive Ph. Eur. 2.4.24: Related Substances by HPLC testing service for API manufacturers, ensuring compliance with regulatory requirements and improving product quality.

    ---

    EUROLABS SERVICES

    Eurolab offers a range of services related to Ph. Eur. 2.4.24: Related Substances by HPLC testing, including:

  • Sample preparation and extraction

  • Chromatographic separation of related substances

  • Detection and quantitation of individual impurities

    • CONTACT US

    For more information about Eurolabs services, please contact us at infoeurolab.com(mailto:infoeurolab.com) or 1-800-EUROLAB.

    Need help or have a question?
    Contact us for prompt assistance and solutions.

    CONTACT US +902127020000

    Latest News

    View all

    Eurolab Successfully Renews ISO 17025 Accreditation

    Read More

    Expanded Cosmetic Safety Testing Portfolio Now Available at Eurolab

    Read More

    Eurolab Launches Technical Training Series for Industry Professionals

    Read More

    JOIN US
    Want to make a difference?

    Careers