EUROLAB
usp-853-atomic-absorption-spectroscopy-for-trace-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 <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 <853>: Atomic Absorption Spectroscopy for Trace Impurities Laboratory Testing Service

Provided by Eurolab: A Comprehensive Guide

Table of Contents

1. Standard-Related Information

1.1 Overview of Relevant Standards

1.2 International and National Standards

1.3 Standard Development Organizations

1.4 Evolution of Standards

1.5 Specific Standard Numbers and Scope

1.6 Compliance Requirements for Different Industries

2. Standard Requirements and Needs

2.1 Business and Technical Reasons for Conducting USP <853> Testing

2.2 Consequences of Not Performing this Test

2.3 Industries and Sectors Requiring this Testing

2.4 Risk Factors and Safety Implications

3. Test Conditions and Methodology

3.1 Step-by-Step Explanation of the Test Procedure

3.2 Equipment and Instruments Used

3.3 Testing Environment Requirements

3.4 Sample Preparation Procedures

3.5 Testing Parameters and Conditions

4. Test Reporting and Documentation

4.1 Documentation and Reporting of Test Results

4.2 Report Format and Structure

4.3 Interpretation of Test Results

5. Why this Test Should be Performed

5.1 Benefits and Advantages

5.2 Risk Assessment and Mitigation through Testing

5.3 Quality Assurance and Compliance Benefits

6. Why Eurolab Should Provide this Service

6.1 Expertise and Experience in the Field

6.2 State-of-the-Art Equipment and Facilities

6.3 Qualified and Certified Personnel

Standard-Related Information

USP <853> is a comprehensive standard that outlines the requirements for Atomic Absorption Spectroscopy (AAS) testing for trace impurities in pharmaceuticals, food products, and other industries. This standard is part of the United States Pharmacopeia (USP) series, which provides standards for laboratory testing and quality control.

1.1 Overview of Relevant Standards

The following standards are relevant to USP <853>:

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

  • ASTM E2759-19 (Standard Practice for Calibration of Atomic Absorption Spectroscopy (AAS) Instruments)

  • EN ISO/IEC 17020:2012 (Conformity assessment - Requirements for the operation of various types of bodies performing inspection)

    • 1.2 International and National Standards

    USP <853> is aligned with international standards, including:

  • ISO 11855-4:2006 (Analytical chemistry Spectroscopy Part 4: Atomic absorption spectroscopy)

  • ASTM E2759-19 (Standard Practice for Calibration of Atomic Absorption Spectroscopy (AAS) Instruments)

    • 1.3 Standard Development Organizations

    The following organizations are involved in the development and maintenance of USP <853>:

  • United States Pharmacopeia (USP)

  • International Organization for Standardization (ISO)

  • American Society for Testing and Materials (ASTM)

    • 1.4 Evolution of Standards

    Standards evolve over time to reflect advances in technology, scientific understanding, and regulatory requirements.

    1.5 Specific Standard Numbers and Scope

    The following standard numbers are relevant to USP <853>:

  • ISO 11855-4:2006 (Analytical chemistry Spectroscopy Part 4: Atomic absorption spectroscopy)

  • ASTM E2759-19 (Standard Practice for Calibration of Atomic Absorption Spectroscopy (AAS) Instruments)

    • 1.6 Compliance Requirements for Different Industries

    Compliance with USP <853> is required in various industries, including:

  • Pharmaceuticals

  • Food and beverages

  • Cosmetics and personal care products

    • Standard Requirements and Needs

    USP <853> testing is essential for ensuring the quality and safety of pharmaceuticals, food products, and other materials.

    2.1 Business and Technical Reasons for Conducting USP <853> Testing

    The main reasons for conducting USP <853> testing include:

  • Ensuring product quality and safety

  • Maintaining regulatory compliance

  • Preventing contamination and adulteration

  • Ensuring consistency and reproducibility of test results

    • 2.2 Consequences of Not Performing this Test

    Failure to conduct USP <853> testing can result in:

  • Product recalls or withdrawals

  • Regulatory non-compliance

  • Damage to reputation and brand value

  • Financial losses due to product contamination or adulteration

    • 2.3 Industries and Sectors Requiring this Testing

    USP <853> testing is required in various industries, including:

  • Pharmaceuticals

  • Food and beverages

  • Cosmetics and personal care products

    • 2.4 Risk Factors and Safety Implications

    The main risk factors associated with USP <853> testing include:

  • Contamination or adulteration of test samples

  • Inaccurate or unreliable test results

  • Failure to comply with regulatory requirements

    • Test Conditions and Methodology

    USP <853> testing involves a series of steps, including sample preparation, instrument calibration, and data analysis.

    3.1 Step-by-Step Explanation of the Test Procedure

    The following steps are involved in USP <853> testing:

  • Sample preparation (e.g., homogenization, dilution)

  • Instrument calibration

  • Atomic absorption spectroscopy

  • Data analysis and reporting

    • 3.2 Equipment and Instruments Used

    USP <853> testing involves the use of specialized equipment, including:

  • Atomic absorption spectrometers

  • Peristaltic pumps

  • Nebulizers

    • 3.3 Testing Environment Requirements

    The following environmental conditions are required for USP <853> testing:

  • Temperature control (e.g., 2C)

  • Humidity control (e.g., 40-60)

  • Air quality control (e.g., clean air supply)

    • 3.4 Sample Preparation Procedures

    Sample preparation involves a series of steps, including homogenization and dilution.

    3.5 Testing Parameters and Conditions

    The following testing parameters and conditions are required for USP <853> testing:

  • Wavelength selection

  • Slit width adjustment

  • Nebulizer gas flow rate

  • Sample injection volume

    • Test Reporting and Documentation

    USP <853> test results must be documented and reported in accordance with regulatory requirements.

    4.1 Documentation and Reporting of Test Results

    The following information must be included in the test report:

  • Sample identification (e.g., batch number, product name)

  • Testing method used

  • Instrument calibration data

  • Test results (including any deviations or outliers)

    • 4.2 Report Format and Structure

    USP <853> reports must comply with regulatory requirements, including format and structure.

    Why this Test Should be Performed

    USP <853> testing is essential for ensuring the quality and safety of pharmaceuticals, food products, and other materials.

    5.1 Benefits and Advantages

    The main benefits and advantages of USP <853> testing include:

  • Ensuring product quality and safety

  • Maintaining regulatory compliance

  • Preventing contamination and adulteration

    • 5.2 Risk Assessment and Mitigation through Testing

    USP <853> testing helps to mitigate risks associated with contamination, adulteration, and non-compliance.

    Why Eurolab Should Provide this Service

    Eurolab is a leading laboratory service provider that offers USP <853> testing services.

    6.1 Expertise and Experience in the Field

    Eurolab has extensive expertise and experience in the field of atomic absorption spectroscopy and quality control.

    6.2 State-of-the-Art Equipment and Facilities

    Eurolab has access to state-of-the-art equipment and facilities, ensuring accurate and reliable test results.

    Conclusion

    USP <853> testing is a critical aspect of quality control and regulatory compliance in various industries. By understanding the standard-related information, requirements, and methodology involved in USP <853> testing, laboratories can ensure that they are providing high-quality services to their clients.

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