EUROLAB
ep-222-uv-visible-spectrophotometry-assay
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 2.2.20 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 <857> UV-Visible Spectroscopy System SuitabilityUSP <85> Bacterial Endotoxins Test for Parenteral PreparationsUSP <905> Uniformity of Dosage Units for CapsulesUSP <905> Uniformity of Dosage Units Testing

EP 2.2.2 UV-Visible Spectrophotometry Assay Laboratory Testing Service: A Comprehensive Guide

As a leading laboratory testing service provider, Eurolab offers expert analysis for EP 2.2.2 UV-Visible Spectrophotometry Assay testing. This article serves as a comprehensive guide to this specific laboratory test, covering all aspects of the testing service.

The EP 2.2.2 UV-Visible Spectrophotometry Assay test is governed by several international and national standards. The most relevant standards for this testing service are:

  • ISO 10923:1995: This standard provides a general guide for the determination of the absorbance spectra of materials in the ultraviolet and visible region.

  • ASTM E275-09(2014): This standard specifies the requirements for measuring reflectance and transmittance with a spectrophotometer using a diffuse illumination, 8 observer geometry.

  • EN ISO 14531: This standard provides a method for determining the absorbance spectra of materials in the ultraviolet and visible region.

    • These standards are essential for ensuring that laboratory testing services provide accurate and reliable results. They specify the requirements for equipment, sampling, and analysis procedures to ensure compliance with regulatory requirements.

    The international and national standards governing this specific laboratory test are developed by standard development organizations such as:

  • International Organization for Standardization (ISO): ISO is responsible for developing and publishing international standards.

  • American Society for Testing and Materials (ASTM): ASTM develops and publishes voluntary consensus standards.

  • European Committee for Electrotechnical Standardization (CENELEC): CENELEC develops and publishes European standards.

    • Standards evolve over time to reflect advances in technology, changes in regulatory requirements, or new testing methodologies. This ensures that laboratory testing services remain compliant with the latest regulations and standards.

    The EP 2.2.2 UV-Visible Spectrophotometry Assay test is essential for ensuring product quality and safety. The business and technical reasons for conducting this test are:

  • Product safety: This test ensures that materials meet regulatory requirements for absorbance spectra, reducing the risk of product failure.

  • Quality control: Regular testing helps to identify any changes in material properties, allowing manufacturers to adjust their production processes accordingly.

  • Compliance with regulations: Compliance with international and national standards is mandatory for many industries.

    • The consequences of not performing this test can be severe, including:

  • Product recalls

  • Reduced product quality and safety

  • Non-compliance with regulatory requirements

    • Industries that require EP 2.2.2 UV-Visible Spectrophotometry Assay testing include:

  • Pharmaceuticals: To ensure the efficacy and stability of active pharmaceutical ingredients (APIs)

  • Cosmetics: To verify the presence of specific ingredients and their absorbance spectra

  • Food industry: To test for food additives, flavorings, or colorants

    • Risk factors associated with this testing include:

  • Equipment malfunction or calibration issues

  • Sampling errors

  • Incorrect analysis procedures

    • Quality assurance and quality control measures are essential to ensure accurate results. This includes regular equipment maintenance, calibration, and validation.

    The EP 2.2.2 UV-Visible Spectrophotometry Assay test is conducted using the following equipment:

  • Spectrophotometer: A high-performance spectrophotometer capable of measuring absorbance spectra in the ultraviolet and visible region.

  • Sampling equipment: Automated sampling systems to ensure accurate and precise sample handling.

    • The testing environment requires specific conditions, including:

  • Temperature control: 20C 1C

  • Humidity control: 50 10

  • Pressure control: atmospheric pressure

    • Sample preparation procedures involve:

  • Homogenization: Ensuring the sample is homogeneous to prevent sampling errors.

  • Aliquoting: Measuring and preparing a representative sample aliquot for analysis.

    • The testing parameters and conditions include:

  • Wavelength range: 200-800 nm

  • Spectral resolution: 1 nm

  • Measurement time: dependent on wavelength

    • The measurement and analysis methods involve:

  • Absorbance spectra measurement

  • Peak detection and integration

  • Result calculation

    • Calibration and validation procedures are essential to ensure accurate results. This includes regular calibration of the spectrophotometer, instrument qualification, and method validation.

    The test report format and structure include:

  • Test summary: Overview of the testing service performed.

  • Results: Detailed results of the absorbance spectra measurement.

  • Certification: Statement of compliance with regulatory requirements.

    • The interpretation of test results involves:

  • Comparing measured values to reference values

  • Identifying any deviations from expected results

    • Accurate documentation and reporting are essential for maintaining regulatory compliance and ensuring accurate communication between laboratory testing services and customers.

    Conclusion

    In conclusion, the EP 2.2.2 UV-Visible Spectrophotometry Assay test is a critical component of quality control in various industries. This comprehensive guide has outlined the standard-related information, requirements, and needs for this specific laboratory test. By understanding the importance of accurate testing and compliance with regulatory requirements, manufacturers can ensure product safety, quality, and efficacy.

    About Eurolab

    As a leading laboratory testing service provider, Eurolab offers expert analysis for EP 2.2.2 UV-Visible Spectrophotometry Assay testing. With state-of-the-art equipment and highly trained technicians, Eurolab ensures accurate results and compliance with regulatory requirements. Contact us today to learn more about our laboratory testing services.

    References

  • ISO 10923:1995

  • ASTM E275-09(2014)

  • EN ISO 14531

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