EUROLAB
ep-2224-absorption-spectrophotometry-in-the-ir-region
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 2.2.28 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

Comprehensive Guide to EP 2.2.24 Absorption Spectrophotometry in the IR Region Testing Services by Eurolab

EP 2.2.24 Absorption Spectrophotometry in the IR Region is a laboratory testing service governed by various international and national standards. The most relevant standards for this test include:

  • ISO 17025:2017 - General requirements for the competence of testing and calibration laboratories (International Organization for Standardization)

  • ASTM E1252-15 - Standard Practice for Infrared Multidimensional Microscopy (IRMM) in the Near-Infrared (NIR) Region (American Society for Testing and Materials)

  • EN 12662:2016 - Determination of the thermal conductivity of materials by the transient plane source method (European Committee for Standardization)

  • TSE EN ISO 17025:2017 - General requirements for the competence of testing and calibration laboratories (Turkish Standards Institution)

    • These standards ensure that laboratory test results are accurate, reliable, and comparable. The legal and regulatory framework surrounding this testing service includes:

  • Regulation (EU) No 1907/2006 on the Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH) (European Union)

  • GHS (Global Harmonized System of Classification and Labelling of Chemicals) (United Nations)

    • International standard development organizations, such as ISO and ASTM, play a crucial role in establishing and maintaining standards for laboratory testing services. Standard development involves:

    1. Identifying the need for a new or revised standard

    2. Forming a technical committee to develop the standard

    3. Conducting public reviews and comments

    4. Finalizing the standard after approval by the relevant organization

    Standards evolve over time due to advances in technology, changes in regulatory requirements, or improvements in testing methodologies.

    EP 2.2.24 Absorption Spectrophotometry in the IR Region is essential for various industries, including:

  • Pharmaceuticals: To ensure the quality and purity of active pharmaceutical ingredients

  • Cosmetics: To verify the presence of specific ingredients or contaminants

  • Food and Beverage: To detect adulteration or contamination

  • Chemicals: To determine the composition and purity of chemical substances

    • This test is required due to:

    1. Regulatory compliance: Manufacturers must adhere to standards and regulations, such as REACH.

    2. Product safety and reliability: Ensuring the quality and purity of products reduces the risk of adverse effects on humans and the environment.

    3. Quality assurance and control: Regular testing helps maintain product consistency and quality.

    The consequences of not performing this test include:

  • Inadequate product quality

  • Regulatory non-compliance

  • Safety risks for consumers and the environment

    • The EP 2.2.24 Absorption Spectrophotometry in the IR Region testing service involves:

    1. Sample preparation: Preparing the sample according to the standards requirements.

    2. Instrument calibration: Calibrating the spectrometer using certified reference materials.

    3. Measurement and analysis: Collecting data using a spectrometer, followed by analysis using software.

    The testing equipment and instruments used include:

  • Spectrometer: A device capable of measuring absorption in the IR region.

  • Calibration standards: Certified reference materials for instrument calibration.

    • The testing environment requirements include:

  • Temperature: Maintaining a stable temperature within the acceptable range.

  • Humidity: Controlling humidity levels to prevent moisture-related issues.

  • Pressure: Ensuring that pressure is within the specified limits.

    • Eurolabs test reporting and documentation process involves:

    1. Reporting format: Providing a clear and concise report, including:

    Sample identification

    Test method used

    Results with units

    Uncertainty of measurement

    2. Certification and accreditation: Issuing certificates of conformity, as required by regulatory authorities.

    3. Traceability and documentation: Maintaining records of calibration, maintenance, and testing activities.

    Performing EP 2.2.24 Absorption Spectrophotometry in the IR Region testing provides numerous benefits:

    1. Risk assessment and mitigation: Identifying potential risks and ensuring product safety.

    2. Quality assurance and compliance: Meeting regulatory requirements and maintaining product consistency.

    3. Competitive advantages: Demonstrating a commitment to quality and customer confidence.

    4. Cost savings and efficiency improvements: Reducing the risk of product recalls, rework, or waste.

    Eurolabs expertise in laboratory testing services ensures that:

    1. Accurate results: Our trained personnel and calibrated equipment guarantee reliable test results.

    2. Compliance with regulations: We maintain up-to-date knowledge of regulatory requirements, ensuring compliance.

    3. Quality control and assurance: Regular internal audits and quality checks ensure our processes meet the highest standards.

    Conclusion

    EP 2.2.24 Absorption Spectrophotometry in the IR Region is a critical laboratory testing service for various industries. By understanding the relevant standards, test conditions, and methodology, manufacturers can ensure product safety, regulatory compliance, and quality assurance. Eurolabs expertise and commitment to quality make us an ideal partner for this testing service.

    Appendices

  • List of references: A comprehensive list of relevant standards, regulations, and publications.

  • Glossary: Definitions of key terms related to laboratory testing services.

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

    CONTACT US +902127020000

    Latest News

    View all

    Eurolab Successfully Renews ISO 17025 Accreditation

    Read More

    Expanded Cosmetic Safety Testing Portfolio Now Available at Eurolab

    Read More

    Eurolab Launches Technical Training Series for Industry Professionals

    Read More

    JOIN US
    Want to make a difference?

    Careers