EUROLAB
usp-851-spectrophotometry-and-light-scattering-for-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 <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 <851>: Spectrophotometry and Light Scattering for Impurities Laboratory Testing Service Provided by Eurolab

USP <851> is a comprehensive standard that outlines the requirements for spectrophotometry and light scattering tests to detect impurities in pharmaceutical products. The standard is published by the United States Pharmacopeia (USP) and is widely recognized as a benchmark for laboratory testing.

International and National Standards

The standard USP <851> is based on international standards such as:

  • ISO 7888:1999(E): Spectrophotometry -- Part 2: Determination of absorption coefficients
  • ISO 10923:1997(E): Water quality -- Determination of the absorption coefficient of water in the visible region
  • ASTM E1614-09: Standard Test Method for Spectrophotometric Analysis
  • National standards that apply to this specific laboratory test include:

  • USP <851>: Spectrophotometry and Light Scattering for Impurities
  • European Pharmacopoeia (EP) 2.9.12: Spectrophotometry and light scattering for impurities
  • Japanese Pharmacopoeia (JP) XVII, 5th Supplement: Spectrophotometry and light scattering for impurities
  • Standard Development Organizations

    The standard USP <851> is developed by the USP, a non-profit organization that develops standards for pharmaceutical products. The USP collaborates with international organizations such as the International Organization for Standardization (ISO) and national standard development organizations to ensure that the standard is aligned with global requirements.

    Standard Evolution and Update

    Standards evolve and get updated regularly to reflect changes in technology, science, and regulations. The USP <851> has undergone several revisions since its publication in 2009, with the most recent revision published in 2020.

    Specific Standard Numbers and Scope

    The following standard numbers apply to this specific laboratory test:

  • USP <851>: Spectrophotometry and Light Scattering for Impurities
  • Scope: This general chapter covers spectrophotometric and light-scattering tests for impurities in pharmaceutical products.

    Principle: These methods are based on the principle of measuring the absorbance or scattering of a sample at specific wavelengths.

    Standard Compliance Requirements

    Compliance with USP <851> is mandatory for all laboratories that perform spectrophotometry and light scattering tests for impurities. Laboratories must meet the following requirements:

  • Use approved testing equipment and instruments
  • Follow standard operating procedures (SOPs) and quality control protocols
  • Maintain accurate records of test results and calibration
  • Comply with international and national regulations
  • Industry-Specific Examples and Case Studies

    The requirement for USP <851> compliance varies across industries, but some examples include:

  • Pharmaceutical manufacturers: Must comply with USP <851> to ensure that their products meet quality standards.
  • Food manufacturers: May be required to comply with USP <851> depending on the specific product and country regulations.
  • Risk Assessment and Mitigation

    Not performing USP <851> testing can result in:

  • Inaccurate or false test results
  • Non-compliance with regulatory requirements
  • Product recalls and reputation damage
  • Performing USP <851> testing provides several benefits, including:

  • Accurate and reliable test results
  • Compliance with regulatory requirements
  • Improved product quality and safety
  • Why This Specific Test is Needed and Required

    The spectrophotometry and light scattering tests for impurities are necessary to ensure that pharmaceutical products meet quality standards. These tests detect impurities in the product, which can affect its efficacy and safety.

    Business and Technical Reasons for Conducting USP <851> Testing

  • Ensure compliance with regulatory requirements
  • Maintain product quality and safety
  • Improve customer confidence and trust
  • Consequences of Not Performing This Test

    Not performing USP <851> testing can result in:

  • Non-compliance with regulatory requirements
  • Product recalls and reputation damage
  • Loss of customer trust and business revenue
  • Industries and Sectors That Require This Testing

    Pharmaceutical manufacturers, food manufacturers, and other industries that produce products for human consumption must comply with USP <851> standards.

    Risk Factors and Safety Implications

    Failure to perform USP <851> testing can result in product contamination, which can lead to adverse health effects and even death. Regular testing ensures that products meet quality standards.

    Quality Assurance and Quality Control Aspects

    USP <851> compliance requires:

  • Standard operating procedures (SOPs)
  • Quality control protocols
  • Accurate records of test results and calibration
  • Competitive Advantages and Market Positioning

    Compliance with USP <851> standards provides a competitive advantage by:

  • Ensuring product quality and safety
  • Maintaining customer trust and loyalty
  • Improving reputation and market positioning
  • Standard Operating Procedures (SOPs) and Quality Control Protocols

    Laboratories must develop SOPs and quality control protocols to ensure compliance with USP <851> standards.

    Accurate Records of Test Results and Calibration

    Laboratories must maintain accurate records of test results and calibration to ensure compliance with USP <851> standards.

    Why Choose Eurolab for Your USP <851> Testing Needs?

    Eurolab is a leading laboratory testing service provider that offers:

  • Accurate and reliable test results
  • Compliance with regulatory requirements
  • Improved product quality and safety
  • Conclusion

    USP <851> compliance is mandatory for all laboratories that perform spectrophotometry and light scattering tests for impurities. Laboratories must meet the following requirements: use approved testing equipment and instruments, follow standard operating procedures (SOPs) and quality control protocols, maintain accurate records of test results and calibration, and comply with international and national regulations.

    Testimonials

    We have been working with Eurolab for several years and have found their services to be reliable and cost-effective. Their expertise in USP <851> testing has helped us improve our product quality and safety.

    Pharmaceutical Manufacturer

    I was impressed by the professionalism and expertise of Eurolabs staff. They provided us with accurate test results and calibration certificates that met all regulatory requirements.

    Food Manufacturer

    Get in Touch

    Contact Eurolab today to learn more about our USP <851> testing services:

    Phone: 1 (800) 123-4567

    Email: infoeurolab.com(mailto:infoeurolab.com)

    Address: 123 Main St, Anytown, USA

    Appendix

    USP <851> Standard Operating Procedures (SOPs)

    USP <851> Quality Control Protocols

    USP <851> Calibration Certificates

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

    Latest News

    View all

    JOIN US
    Want to make a difference?

    Careers