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usp-857-uv-vis-spectroscopy-for-impurity-quantification
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 <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 USP <857>: UV-Vis Spectroscopy for Impurity Quantification Laboratory Testing Service by Eurolab

Standard-Related Information

USP <857> is a United States Pharmacopeia (USP) standard that outlines the requirements for UV-Vis spectroscopy for impurity quantification testing. This standard is widely recognized and adopted by regulatory agencies worldwide, including the US FDA, EMA, and other international authorities.

The legal and regulatory framework surrounding this testing service is governed by various standards and regulations, including:

  • ISO 17025:2005 (General requirements for the competence of testing and calibration laboratories)

  • ASTM E1656-14 (Standard Practice for Infrared Multivariate Quantitation of Active Pharmaceutical Ingredients in Dosage Form Excipients)

  • EN 14661:2011 (Pharmaceuticals -- Impurities in active substances -- Determination by liquid chromatography coupled with mass spectrometry or tandem mass spectrometry)

  • TSE (Turkish Standards Institution) TS ISO/IEC 17025:2006

    • These standards and regulations dictate the requirements for laboratory testing, including equipment calibration, sample preparation, and data analysis. The International Organization for Standardization (ISO), American Society for Testing and Materials (ASTM), European Committee for Standardization (CEN), and Turkish Standards Institution (TSE) are responsible for developing and maintaining these standards.

    The development of standards is a continuous process, with new versions being released as technology advances or requirements change. This ensures that laboratory testing remains aligned with the latest scientific knowledge and regulatory requirements.

    Standard Requirements and Needs

    USP <857> specifies the requirements for UV-Vis spectroscopy for impurity quantification testing, including:

  • Equipment calibration: The testing equipment must be calibrated in accordance with the manufacturers instructions and maintained regularly to ensure accuracy.

  • Sample preparation: The sample must be prepared according to the standard operating procedure (SOP) to ensure homogeneity and representative analysis.

  • Data analysis: The data must be analyzed using appropriate software and statistical methods to determine impurity levels.

    • The business and technical reasons for conducting USP <857> testing include:

  • Ensuring product safety and efficacy

  • Complying with regulatory requirements

  • Maintaining quality assurance and control

  • Building customer confidence and trust

    • Consequences of not performing this test include:

  • Non-compliance with regulatory requirements

  • Product recalls or withdrawals

  • Loss of market share and revenue

  • Decreased customer satisfaction and loyalty

    • Industries that require USP <857> testing include pharmaceuticals, biotechnology, and food and beverage.

    Test Conditions and Methodology

    The following equipment is used for conducting USP <857> testing:

  • UV-Vis spectrophotometer (e.g., Thermo Scientific Evolution 300)

  • Sample preparation equipment (e.g., vortex mixer, centrifuge)

    • The testing environment requirements include:

  • Temperature: 20C 2C

  • Humidity: 50 10

  • Pressure: Atmospheric pressure

    • Sample preparation procedures involve weighing and dissolving the sample in a suitable solvent.

    Testing parameters and conditions include:

  • Wavelength range: 190-1100 nm

  • Scan rate: 500 nm/min

  • Bandwidth: 1 nm

    • Measurement and analysis methods involve using software (e.g., Thermo Scientific ChromaFit) to determine impurity levels.

    Calibration and validation procedures involve regular calibration of the equipment and validation of the analytical method.

    Quality control measures during testing include:

  • Regularly checking the equipment for accuracy and precision

  • Using certified reference materials for calibration

    • Data collection and recording procedures involve documenting all test results, including sample preparation, testing parameters, and impurity levels.

    Test Reporting and Documentation

    Test results are documented in a report format that includes:

  • Sample identification and description

  • Testing parameters and conditions

  • Impurity levels and limits of detection (LOD) and quantification (LOQ)

  • Statistical analysis and data interpretation

    • Certification and accreditation aspects include:

  • Certification by a recognized accreditation body (e.g., ISO/IEC 17025:2005)

  • Accreditation to perform USP <857> testing

    • Traceability and documentation requirements include maintaining records of all test results, including sample preparation, testing parameters, and impurity levels.

    Reporting standards and formats include:

  • Standard report format as per USP <857>

  • Electronic reporting systems (e.g., Eurolabs online portal)

    • Why This Test Should Be Performed

    Benefits of performing USP <857> testing include:

  • Ensuring product safety and efficacy

  • Complying with regulatory requirements

  • Maintaining quality assurance and control

  • Building customer confidence and trust

    • Risk assessment and mitigation through testing involve identifying potential impurities and determining their levels.

    Quality assurance and compliance benefits include:

  • Meeting regulatory requirements

  • Reducing the risk of non-compliance and product recalls or withdrawals

    • Why Choose Eurolab for USP <857> Testing

    Eurolab offers a comprehensive range of laboratory testing services, including USP <857> testing. Our experienced team and state-of-the-art equipment ensure accurate and reliable results.

    Our reporting format is in accordance with the standard report format as per USP <857>, and we maintain electronic records of all test results.

    In conclusion, USP <857> testing is a critical requirement for ensuring product safety and efficacy, complying with regulatory requirements, maintaining quality assurance and control, and building customer confidence and trust. Eurolabs experienced team and state-of-the-art equipment ensure accurate and reliable results, making us the ideal choice for USP <857> testing.

    Contact Us

    For more information on our USP <857> testing services or to request a quote, please contact us at:

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