EUROLAB
usp-466-identification-and-quantification-of-degradants
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. 5.10: 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 <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

USP <466>: Identification and Quantification of Degradants Laboratory Testing Service by Eurolab

The United States Pharmacopeia (USP) <466> is a comprehensive standard that outlines the requirements for the identification and quantification of degradants in pharmaceuticals. This standard is designed to ensure the quality and safety of medicinal products by establishing specific guidelines for testing.

Legal and Regulatory Framework

The USP <466> is based on the principles of good laboratory practice (GLP) and good manufacturing practice (GMP). The regulatory framework surrounding this standard includes:

  • 21 CFR Part 211: Current Good Manufacturing Practice for Finished Pharmaceuticals

  • 21 CFR Part 820: Quality System Regulation

  • FDA Guidance Documents, such as Guidance for Industry: Stability Testing of Drug Substances and Products

    • International and National Standards

    The USP <466> is based on international standards, including:

  • ISO 10993-13: Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products

  • ASTM E2224: Standard Practice for Quantitative Determination of Degradation Products in Pharmaceutical Materials

    • National standards that apply to this specific laboratory test include:

  • USP <466>: Identification and Quantification of Degradants

  • EP 2.2.46: Impurities: General chapter

  • JP 2.5.18: Tests for impurities

  • ICH Q3A(R2): Impurities: Guideline for residual solvents

    • Standard Development Organizations

    The standard development organizations involved in creating the USP <466> include:

  • United States Pharmacopeia (USP)

  • International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)

  • American Society for Testing and Materials (ASTM)

    • Evolution of Standards

    Standards evolve over time to reflect new scientific knowledge, technological advancements, and changing regulatory requirements. The USP <466> is revised periodically to ensure that it remains current and relevant.

    Standard Numbers and Scope

    The USP <466> has the following standard numbers and scope:

  • USP 46: Identification and Quantification of Degradants

  • ISO 10993-13: Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products

    • Compliance Requirements

    Compliance with this standard is required for all pharmaceutical manufacturers, contract laboratories, and regulatory agencies involved in the testing of medicinal products.

    Standard Compliance Requirements by Industry

    The USP <466> applies to various industries, including:

  • Pharmaceuticals

  • Biotechnology

  • Cosmetics

  • Medical devices

    • Each industry has specific compliance requirements and guidelines that must be followed.

    ---

    Why is this test needed?

    The identification and quantification of degradants are essential for ensuring the quality, safety, and efficacy of medicinal products. Degradants can have significant effects on the products performance, stability, and shelf life.

    Business and Technical Reasons for Conducting USP <466> Testing

    Conducting USP <466> testing is necessary to:

  • Ensure compliance with regulatory requirements

  • Validate product quality and stability

  • Establish specifications for degradants

  • Monitor changes in product composition over time

    • Consequences of Not Performing this Test

    Failure to conduct USP <466> testing can result in:

  • Regulatory non-compliance

  • Product recalls or withdrawals

  • Loss of customer confidence

  • Decreased market share and revenue

    • Industries and Sectors that Require this Testing

    The USP <466> applies to various industries, including:

  • Pharmaceuticals

  • Biotechnology

  • Cosmetics

  • Medical devices

    • Each industry has specific testing requirements and guidelines that must be followed.

    ---

    Step-by-Step Explanation of the Test

    The USP <466> test involves the following steps:

    1. Sample preparation: The sample is prepared according to the standard procedures.

    2. Testing equipment: Specific testing equipment, such as high-performance liquid chromatography (HPLC), gas chromatography-mass spectrometry (GC-MS), and nuclear magnetic resonance (NMR) spectroscopy, are used for analysis.

    3. Measurement and analysis: The degradants are measured and analyzed using the selected instruments.

    Testing Equipment and Instruments

    The following equipment is used for USP <466> testing:

  • HPLC

  • GC-MS

  • NMR spectroscopy

    • Testing Environment Requirements

    The testing environment must meet specific requirements, including temperature, humidity, and pressure conditions.

    Sample Preparation Procedures

    Sample preparation involves various steps, including:

    1. Extraction: The sample is extracted according to the standard procedures.

    2. Clean-up: The extract is cleaned up using specific techniques.

    3. Concentration: The concentrated sample is ready for analysis.

    ---

    The USP <466> is a comprehensive standard that outlines the requirements for the identification and quantification of degradants in pharmaceuticals. This standard is designed to ensure the quality and safety of medicinal products by establishing specific guidelines for testing.

    Standard-Related Information

    The USP <466> is based on international standards, including ISO 10993-13: Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products, and ASTM E2224: Standard Practice for Quantitative Determination of Degradation Products in Pharmaceutical Materials.

    Consequences of Not Performing this Test

    Failure to conduct USP <466> testing can result in regulatory non-compliance, product recalls or withdrawals, loss of customer confidence, and decreased market share and revenue.

    Persuasive Content

    The USP <466> is a critical standard for ensuring the quality and safety of medicinal products. Compliance with this standard is essential for maintaining regulatory compliance, ensuring product stability, and protecting public health.

    ---

    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