EUROLAB
usp-857-uv-visible-spectroscopy-system-suitability
Pharmacopoeia-Based Assays BP Appendix VIII G: Total Ash in Herbal ProductsBP Appendix X: Identification Tests for Organic CompoundsBP Appendix XI C: Test for Water Insoluble MatterBP Appendix XII C: Uniformity of Weight TestBP Appendix XII F: Microbial Limits for Cosmetic PreparationsBP Appendix XII G: Total Aerobic Microbial Count in LiquidsBP Appendix XIV A: Refractive Index Measurement for OilsBP Appendix XIV C: Determination of pH Using ElectrodesBP Appendix XIV F: Assay of Sulphates by GravimetryBP Appendix XV B: Assay of Chloride in Raw MaterialsEP 2.2.2 UV-Visible Spectrophotometry AssayEP 2.2.20 Thin-Layer Chromatography Identity TestingEP 2.2.24 Absorption Spectrophotometry in the IR RegionEP 2.2.28 Gas Chromatography Method ValidationEP 2.2.3 Potentiometric pH MeasurementEP 2.2.32 Loss on Drying DeterminationEP 2.2.38 Differential Scanning Calorimetry AssayEP 2.4.4 Sulphated Ash for ExcipientsEP 2.4.8 Sulphated Ash AnalysisEP 2.5.12 Water Content (Karl Fischer Method)EP 2.6.12 Microbiological Examination of Non-Sterile ProductsEP 2.6.14 Microbiological Integrity Testing for PackagingEP 2.6.27 Bacterial Endotoxin Test Using Recombinant Factor CEP 2.9.1 Uniformity of Mass for Single-Dose PreparationsEP 2.9.3 Friability Testing for Uncoated TabletsEP 2.9.5 Hardness of Tablets MeasurementEP 2.9.7 Dissolution Testing for Gastro-resistant TabletsJP 3.01 Uniformity of Content in Powdered DrugsJP 3.03 Color and Clarity of Solution TestingJP 3.05 Osmolarity Testing in Ophthalmic SolutionsJP 4.01 Identification of Active Pharmaceutical IngredientsJP 4.04 Assay of Active Compounds Using UV MethodJP 4.05 Water Determination in Raw MaterialsJP 5.02 Determination of Peroxides in Lipophilic CompoundsJP 6.01 Test for Related Substances Using HPLCJP 6.03 Dissolution Test for Capsule Dosage FormsJP 6.04 Analysis of Pesticide Residues in Herbal MedicinesJP 6.05 Testing for Insoluble Matter in InjectionsJP 7.01 Test for pH in Oral SolutionsJP 7.02 Heavy Metal Test for Injection ProductsJP 8.02 Identity Testing Using IR SpectroscopyJP 8.03 Residual Solvents in APIsJP 9.01 Chromatographic Purity for Active SubstancesJP 9.04 Microbial Limits Test for OintmentsUSP <1029> Good Documentation Practices for TestingUSP <1030> Biological Assay for AntibodiesUSP <1032> Design and Conduct of Bioavailability StudiesUSP <1039> Reduced Sampling and Testing Plan JustificationUSP <1047> Testing for Biotechnological Protein ProductsUSP <1058> Analytical Instrument QualificationUSP <1062> Tablet and Capsule Weight Variation StudyUSP <1078> Good Manufacturing Practices for Bulk ExcipientsUSP <1079> Good Storage and Shipping Practices for Drug ProductsUSP <1088> Stability Testing of Drug SubstancesUSP <1092> Tablet Coating Performance TestingUSP <1106> Whole Package Integrity TestingUSP <1111> Microbiological Quality of Nonsterile ProductsUSP <1116> Control of Bioburden in Clean RoomsUSP <1117> Best Practices for Handling Hazardous CompoundsUSP <1163> Quality Assurance in Pharmaceutical CompoundingUSP <1181> Evaluation of Stability-Indicating MethodsUSP <1191> Stability Testing for Compounded PreparationsUSP <1216> Tablet Friability TestingUSP <121> Sterilization Assurance Level TestingUSP <1224> Transfer of Analytical ProceduresUSP <1225> Validation of Analytical ProceduresUSP <1226> Verification of Compendial ProceduresUSP <1227> Validation of Microbial Recovery from Pharm WatersUSP <1228> Depyrogenation Validation of EquipmentUSP <1231> Water for Pharmaceutical Purposes TestingUSP <231> Heavy Metals Limit Test for PharmaceuticalsUSP <232> Elemental Impurities – Limits in Finished ProductsUSP <233> Elemental Impurities – Procedures for AnalysisUSP <39-NF34> Identification Testing of Active Pharmaceutical IngredientsUSP <41> Weights and Balances Calibration CheckUSP <467> Residual Solvents Testing in Drug SubstancesUSP <51> Antimicrobial Effectiveness Testing in Aqueous FormulationsUSP <61> Microbial Enumeration Tests for Raw MaterialsUSP <62> Tests for Specified MicroorganismsUSP <701> Disintegration Test for Uncoated TabletsUSP <711> Dissolution Testing for Immediate-Release Dosage FormsUSP <788> Particulate Matter in Injections AnalysisUSP <800> Hazardous Drugs Handling ValidationUSP <800> Surface Contamination Testing for Hazardous DrugsUSP <85> Bacterial Endotoxins Test for Parenteral PreparationsUSP <905> Uniformity of Dosage Units for CapsulesUSP <905> Uniformity of Dosage Units Testing

Comprehensive Guide to USP <857> UV-Visible Spectroscopy System Suitability Laboratory Testing Service

Provided by Eurolab: Expertise in Laboratory Testing Services

USP <857> UV-Visible Spectroscopy System Suitability is a laboratory testing service that involves the evaluation of the performance and accuracy of UV-Visible spectroscopy systems. This standard is governed by the United States Pharmacopeia (USP), an independent, non-profit organization that sets standards for pharmaceuticals and related products.

Relevant Standards

  • USP <857> UV-Visible Spectroscopy System Suitability

  • ISO 17212:2015 Analytical instrumentation - General requirements for the validation of quantitative analytical procedures

  • ASTM E2756-19 Standard Practice for Validation of Quantitative Analysis Procedures

  • EN ISO/IEC 17025:2018 General requirements for the competence of testing and calibration laboratories

    • Standard Development Organizations

    The standards governing USP <857> UV-Visible Spectroscopy System Suitability are developed by various organizations, including:

  • United States Pharmacopeia (USP)

  • International Organization for Standardization (ISO)

  • American Society for Testing and Materials (ASTM)

  • European Committee for Standardization (CEN)

    • Standard Compliance Requirements

    Compliance with USP <857> UV-Visible Spectroscopy System Suitability is required by various industries, including:

  • Pharmaceutical industry

  • Biotechnology industry

  • Chemical industry

  • Food industry

    • Consequences of Non-Compliance

    Failure to comply with USP <857> UV-Visible Spectroscopy System Suitability can result in:

  • Rejection of products or samples

  • Delays in product launch or approval

  • Loss of market share and reputation

  • Financial penalties and fines

    • Standard Evolution and Updates

    Standards are continuously updated and revised to reflect new technologies, methodologies, and regulatory requirements. Laboratories must stay up-to-date with the latest standards and guidelines to ensure compliance.

    Example Standard Numbers and Scope

  • USP <857> UV-Visible Spectroscopy System Suitability

    • Scope: Evaluation of performance and accuracy of UV-Visible spectroscopy systems

    Requirements:

    - Linearity

    - Accuracy

    - Precision

    - Range

    - Sensitivity

    - Specificity

    Standard Compliance for Different Industries

  • Pharmaceutical industry: Complying with USP <857> UV-Visible Spectroscopy System Suitability is essential for ensuring the accuracy and reliability of analytical results.

  • Biotechnology industry: Compliance with this standard ensures that biotech products meet regulatory requirements and are safe for human consumption.

    • Why This Specific Test is Needed

    USP <857> UV-Visible Spectroscopy System Suitability testing is necessary to ensure the accuracy, reliability, and safety of analytical results. Inaccurate or unreliable test results can lead to:

  • Rejection of products or samples

  • Delays in product launch or approval

  • Loss of market share and reputation

  • Financial penalties and fines

    • Business and Technical Reasons for Conducting This Test

    Conducting USP <857> UV-Visible Spectroscopy System Suitability testing ensures that laboratory equipment is functioning correctly, reducing the risk of errors and inaccuracies. This test also helps to:

  • Ensure compliance with regulatory requirements

  • Improve product safety and quality

  • Enhance customer confidence and trust

    • Consequences of Not Performing This Test

    Failure to perform USP <857> UV-Visible Spectroscopy System Suitability testing can result in:

  • Inaccurate or unreliable analytical results

  • Product contamination or adulteration

  • Delays in product launch or approval

  • Loss of market share and reputation

    • Industries and Sectors that Require This Testing

    USP <857> UV-Visible Spectroscopy System Suitability testing is required by various industries, including:

  • Pharmaceutical industry

  • Biotechnology industry

  • Chemical industry

  • Food industry

    • Risk Factors and Safety Implications

    Failure to comply with USP <857> UV-Visible Spectroscopy System Suitability can result in:

  • Risk of product contamination or adulteration

  • Risk of inaccurate or unreliable analytical results

  • Risk of financial penalties and fines

    • Quality Assurance and Quality Control Aspects

    USP <857> UV-Visible Spectroscopy System Suitability testing is essential for ensuring quality assurance and control. This test helps to:

  • Ensure compliance with regulatory requirements

  • Improve product safety and quality

  • Enhance customer confidence and trust

    • Competitive Advantages of Having This Testing Performed

    Conducting USP <857> UV-Visible Spectroscopy System Suitability testing provides several competitive advantages, including:

  • Enhanced product safety and quality

  • Improved compliance with regulatory requirements

  • Increased customer confidence and trust

  • Reduced risk of financial penalties and fines

    • Example Requirements for Conducting This Test

  • Equipment: UV-Visible spectroscopy system

  • Reagents: calibration standards, blanks, and reference materials

  • Procedure:

    • Linearity

    Accuracy

    Precision

    Range

    Sensitivity

    Specificity

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