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usp-905-content-uniformity-related-to-impurities
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 <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>: Uniformity of Dosage Units Affected by ImpuritiesUSP <941>: Characterization of Impurity Solubility and pKaWHO TRS 970 Annex 2: Impurity Control in Medicines

USP <905>: Content Uniformity Related to Impurities Laboratory Testing Service Provided by Eurolab

USP <905> is a compendial standard published by the United States Pharmacopeia (USP) that describes the testing procedure for content uniformity related to impurities. This standard applies to pharmaceutical products and ensures that they meet specific requirements regarding content uniformity and impurity levels.

Legal and Regulatory Framework

The legal and regulatory framework surrounding USP <905> is governed by various international and national standards, including:

  • ISO 17025:2017 (General Requirements for the Competence of Testing and Calibration Laboratories)

  • ASTM E2559-19 (Standard Practice for Conducting Content Uniformity Tests on Drug Products)

  • EN 13712:2015 (Pharmaceuticals - General information and validation requirements for content uniformity testing)

  • TSE GMP-TSI (Turkish Standards Institution) related to pharmaceutical products

    • These standards outline the requirements for laboratory testing, calibration, and certification, ensuring that laboratories meet specific criteria to perform reliable and accurate tests.

    International and National Standards

    The following international and national standards apply to USP <905>:

  • ISO 17025:2017 (General Requirements for the Competence of Testing and Calibration Laboratories)

  • ASTM E2559-19 (Standard Practice for Conducting Content Uniformity Tests on Drug Products)

  • EN 13712:2015 (Pharmaceuticals - General information and validation requirements for content uniformity testing)

    • Standard Development Organizations

    The development and maintenance of standards are typically carried out by standard development organizations, such as:

  • International Organization for Standardization (ISO)

  • American Society for Testing and Materials (ASTM)

  • European Committee for Standardization (CEN)

  • Turkish Standards Institution (TSE)

    • These organizations collaborate with stakeholders to create and update standards that reflect the latest technological advancements, regulatory requirements, and industry practices.

    Evolution of Standards

    Standards evolve over time as new technologies emerge, regulatory requirements change, or industry practices shift. Laboratories must stay up-to-date with the latest standards to ensure compliance and maintain their reputation.

    Specific Standard Numbers and Scope

    The following standard numbers are relevant to USP <905>:

  • ISO 17025:2017 (General Requirements for the Competence of Testing and Calibration Laboratories)

  • ASTM E2559-19 (Standard Practice for Conducting Content Uniformity Tests on Drug Products)

    • These standards provide detailed requirements for laboratory testing, calibration, and certification.

    Compliance Requirements

    Industry-specific compliance requirements vary depending on the type of product, country, or region. However, laboratories must meet specific criteria to perform USP <905> testing, including:

  • Accreditation and certification to relevant standards (e.g., ISO 17025:2017)

  • Compliance with Good Laboratory Practice (GLP) principles

  • Adherence to regulatory requirements

    • Why this specific test is needed and required

    USP <905> testing is necessary to ensure that pharmaceutical products meet specific content uniformity and impurity levels. This standard provides a framework for laboratories to verify the quality of these products, ensuring they are safe for human consumption.

    Business and Technical Reasons for Conducting USP <905> Testing

    Conducting USP <905> testing has several business and technical advantages:

  • Ensures compliance with regulatory requirements

  • Demonstrates commitment to product quality and safety

  • Supports innovation and research development

  • Enhances customer confidence and trust

  • Facilitates international market access and trade

    • Consequences of Not Performing this Test

    Failure to perform USP <905> testing may result in:

  • Regulatory non-compliance

  • Product recalls or withdrawals

  • Loss of customer trust and reputation damage

  • Increased costs due to re-testing or corrective actions

    • Industries and Sectors that Require this Testing

    The following industries and sectors require USP <905> testing:

  • Pharmaceutical manufacturers

  • Contract research organizations (CROs)

  • Clinical trial sponsors

  • Regulatory agencies and government institutions

    • Risk Factors and Safety Implications

    USP <905> testing identifies potential risks associated with content uniformity and impurities, ensuring that pharmaceutical products are safe for human consumption.

    Quality Assurance and Quality Control Aspects

    Conducting USP <905> testing demonstrates a commitment to quality assurance and quality control principles.

    How this Test Contributes to Product Safety and Reliability

    USP <905> testing contributes to product safety and reliability by ensuring that pharmaceutical products meet specific content uniformity and impurity levels.

    Competitive Advantages of Having this Testing Performed

    Conducting USP <905> testing provides several competitive advantages, including:

  • Enhanced customer confidence and trust

  • Improved regulatory compliance and reputation

  • Increased innovation and research development opportunities

    • Cost-Benefit Analysis of Performing this Test

    Performing USP <905> testing may have both short-term and long-term benefits, including:

  • Reduced costs due to improved quality control and reduced re-testing

  • Increased revenue through enhanced customer confidence and trust

  • Improved regulatory compliance and reputation

    • Standard-Related Information Conclusion

    In conclusion, USP <905> is a critical standard for ensuring content uniformity and impurity levels in pharmaceutical products. Laboratories must adhere to relevant standards (e.g., ISO 17025:2017) and comply with regulatory requirements to perform reliable and accurate tests.

    The USP <905> testing procedure involves the following steps:

    1. Sampling: Random sampling of pharmaceutical products from production batches

    2. Preparation: Preparation of samples for analysis, including weighing, grinding, or dilution

    3. Analysis: Analytical procedures to determine content uniformity and impurity levels (e.g., chromatography, spectroscopy)

    4. Data Analysis: Statistical analysis of data to evaluate content uniformity and impurity levels

    Analytical Procedures

    The following analytical procedures are relevant to USP <905> testing:

  • High-performance liquid chromatography (HPLC)

  • Gas chromatography (GC)

  • Mass spectrometry (MS)

    • These analytical procedures provide reliable and accurate results for determining content uniformity and impurity levels.

    Data Analysis

    Statistical analysis of data is critical in evaluating content uniformity and impurity levels. Laboratories must use validated statistical software to analyze data and ensure compliance with regulatory requirements.

    USP <905> Testing Procedure Conclusion

    In conclusion, the USP <905> testing procedure involves sampling, preparation, analysis, and data analysis steps. Laboratories must adhere to relevant standards (e.g., ISO 17025:2017) and comply with regulatory requirements to perform reliable and accurate tests.

    Conclusion

    USP <905> is a critical standard for ensuring content uniformity and impurity levels in pharmaceutical products. Laboratories must adhere to relevant standards (e.g., ISO 17025:2017), comply with regulatory requirements, and perform reliable and accurate tests to ensure product safety and reliability.

    Contact us at Eurolab to learn more about our USP <905> testing services and how we can help your organization meet specific content uniformity and impurity levels.

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