EUROLAB
ep-2238-differential-scanning-calorimetry-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 2.2.2 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 2.4.4 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 2.2.38 Differential Scanning Calorimetry Assay Laboratory Testing Service: A Comprehensive Guide

Differential Scanning Calorimetry (DSC) is a widely accepted analytical technique used to measure the thermal properties of materials. The EP 2.2.38 DSC assay testing service provided by Eurolab adheres to various international and national standards, ensuring the accuracy and reliability of test results.

International Standards:

  • ISO 11357-1:2016(en) - Differential scanning calorimetry (DSC) - Part 1: General principles
  • ASTM E1269-17 - Standard Test Method for Calculating Thermophysical Properties Using Linear or Nonlinear Regression Analysis
  • EN 13197:2008A1:2013 - Thermoplastics and ebonite - Determination of the melting point by differential scanning calorimetry (DSC)
  • National Standards:

  • TSE ISO 11357-1:2016(en) - Differential scanning calorimetry (DSC) - Part 1: General principles
  • TS EN 13197:2008A1:2013 - Thermoplastics and ebonite - Determination of the melting point by differential scanning calorimetry (DSC)
  • Standard Development Organizations:

    The International Organization for Standardization (ISO), American Society for Testing and Materials (ASTM), and Turkish Standards Institution (TSE) are prominent standard development organizations that contribute to the development and maintenance of DSC-related standards.

    Evolution of Standards:

    Standards undergo periodic revisions to reflect advances in technology, changes in regulatory requirements, or emerging industry needs. Eurolab stays up-to-date with the latest revisions and updates to ensure compliance with evolving standards.

    Standard Numbers and Scope:

  • ISO 11357-1:2016(en) - Differential scanning calorimetry (DSC) - Part 1: General principles
  • Applies to DSC equipment used for measuring thermal properties of materials

  • ASTM E1269-17 - Standard Test Method for Calculating Thermophysical Properties Using Linear or Nonlinear Regression Analysis
  • Covers the calculation of thermophysical properties using linear or nonlinear regression analysis

  • EN 13197:2008A1:2013 - Thermoplastics and ebonite - Determination of the melting point by differential scanning calorimetry (DSC)
  • Specifies the requirements for determining the melting point of thermoplastics and ebonite using DSC

    Compliance Requirements:

    Manufacturers, suppliers, and users of materials must comply with applicable standards to ensure product safety, quality, and regulatory compliance.

    Standard-Related Regulations:

    Regulatory bodies, such as the European Unions (EU) directives and regulations, often reference or mandate the use of specific standards. Eurolab ensures that our services meet or exceed these requirements.

    Why EP 2.2.38 DSC Assay Testing is Required:

    The EP 2.2.38 DSC assay testing service is essential for various industries, including:

  • Pharmaceuticals
  • Chemicals
  • Materials science
  • Polymer research
  • Biotechnology
  • This test helps ensure product safety, quality, and regulatory compliance by providing accurate thermal property measurements.

    Business and Technical Reasons:

    Conducting EP 2.2.38 DSC assay testing provides numerous benefits, including:

  • Ensuring product safety and reliability
  • Complying with regulatory requirements
  • Enhancing product performance and stability
  • Supporting research and development
  • Consequences of Not Performing this Test:

    Failure to conduct EP 2.2.38 DSC assay testing can lead to:

  • Product failure or malfunction
  • Regulatory non-compliance
  • Damage to reputation and brand image
  • Economic losses due to recalls, litigation, or reputational damage
  • Industries Requiring this Testing:

    The following industries require EP 2.2.38 DSC assay testing:

  • Pharmaceuticals (APIs, excipients)
  • Chemicals (reactants, intermediates)
  • Materials science (polymers, composites)
  • Polymer research
  • Biotechnology (biomaterials, bioactive compounds)
  • Risk Factors and Safety Implications:

    Failure to conduct EP 2.2.38 DSC assay testing can lead to product-related risks, such as:

  • Thermal degradation or decomposition
  • Chemical instability or reactivity
  • Material failure or structural integrity issues
  • Quality Assurance and Quality Control Aspects:

    Eurolabs EP 2.2.38 DSC assay testing service adheres to stringent quality assurance and control measures, including:

  • Calibration and validation procedures
  • Equipment maintenance and calibration schedules
  • Operator training and certification programs
  • Documented test protocols and procedures
  • Test Methodology:

    The EP 2.2.38 DSC assay testing service involves the following steps:

    1. Sample preparation

    2. Instrument setup and calibration

    3. Data collection and analysis

    4. Reporting and interpretation of results

    Equipment and Software Used:

    Eurolab uses state-of-the-art DSC equipment, including:

  • Thermogravimetric Analysis (TGA) systems
  • Differential Scanning Calorimeter (DSC) instruments
  • Data acquisition and analysis software (e.g., TA Instruments Universal Analysis software)
  • Test Reports and Certificates:

    Eurolab provides comprehensive test reports and certificates that include:

  • Test details and parameters
  • Raw data and plots
  • Calculated thermal properties (e.g., specific heat capacity, melting temperature)
  • Conclusion and recommendations for material use or modification
  • Quality Control Measures:

    Eurolab implements the following quality control measures to ensure accuracy and reliability of test results:

  • Regular instrument calibration and maintenance
  • Operator training and certification programs
  • Documented test protocols and procedures
  • Data validation and verification processes
  • Eurolabs comprehensive test reports and certificates include:

  • A detailed description of the testing procedure
  • Raw data and plots
  • Calculated thermal properties and their uncertainties
  • Conclusion and recommendations for material use or modification
  • Conclusion:

    The EP 2.2.38 DSC assay testing service provided by Eurolab ensures accurate and reliable measurements of thermal properties, supporting product safety, quality, and regulatory compliance in various industries.

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

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