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astm-e1356-differential-scanning-calorimetry-of-pharmaceuticals
Thermal Analysis ASTM D3418 Melting and Crystallization Temperature Measurement by DSCASTM D3418 Thermal Analysis of Polymers by DSCASTM D3895 Thermal Stability of Polymers by TGAASTM E1269 DSC Heat Flow Rate DeterminationASTM E1356 Differential Scanning Calorimetry (DSC) for PolymersASTM E1356 DSC of AdhesivesASTM E1356-08 DSC Glass Transition and Melting Point DeterminationASTM E1460 DSC of Composite MaterialsASTM E1461 Laser Flash Method for Thermal DiffusivityASTM E1462 Simultaneous Thermal Analysis of Polymer BlendsASTM E1545 DSC of FoodstuffsASTM E1582 Thermal Analysis of CoatingsASTM E1590 DMA Frequency Sweep TestASTM E1821 Temperature-Dependent Mechanical AnalysisASTM E1952 TGA of High-Temperature StabilityASTM E1959 TGA Analysis of Polymers Under Oxygen AtmosphereASTM E2001 Modulated DSC for Polymer CharacterizationASTM E2004 TGA of Composite MaterialsASTM E2041 Thermal Analysis of Battery MaterialsASTM E2072 TMA of MetalsASTM E2179 DMA Temperature Sweep TestASTM E2232 TMA for Coefficient of Thermal Expansion in MetalsASTM E2280 DSC for Thin Film MaterialsASTM E2297 Thermal Conductivity Measurement by TGAASTM E2429 Thermal Analysis of GlassASTM E2439 Thermogravimetric Analysis of Food ProductsASTM E2546 Measurement of Thermal Expansion by TMAASTM E2548 Simultaneous TGA and DSC AnalysisASTM E2549 Simultaneous TGA-FTIR for Decomposition Gas AnalysisASTM E2580 DMA of ElastomersASTM E2608 Thermal Analysis of Ceramic MaterialsASTM E2677 Thermal Analysis of Pharmaceutical PowdersASTM E2716 Dynamic Mechanical Analysis (DMA) of PolymersASTM E2719 DMA Creep and Recovery TestingASTM E2781 Temperature Modulated DSC for Complex Thermal EventsASTM E2782 Thermomechanical Analysis (TMA) of MaterialsASTM E2783 High-Temperature Thermal AnalysisASTM E344 Heat Capacity Measurements by DSCASTM E537 Thermomechanical Analysis for Dimensional ChangesASTM E968 Thermogravimetric Analysis (TGA) of MaterialsISO 11357-1 Adhesive Thermal PropertiesISO 11357-1 Composite Thermal AnalysisISO 11357-1 Food Thermal PropertiesISO 11357-1 Pharmaceutical Thermal AnalysisISO 11357-1 Pharmaceutical Thermal PropertiesISO 11357-1 Plastics — DSC General PrinciplesISO 11357-1 Plastics — DSC General Testing ProceduresISO 11357-1 Thin Film Thermal CharacterizationISO 11357-2 Plastics — DSC Determination of Glass Transition TemperatureISO 11357-3 Plastics — DSC Crystallization ParametersISO 11357-3 Plastics — DSC Determination of Crystallization TemperatureISO 11357-3 Polymer Thermal PropertiesISO 11357-4 Plastics — DSC Determination of Heat CapacityISO 11357-4 Plastics — Heat Capacity MeasurementISO 11357-5 Plastics — DSC Determination of Oxidation Induction TimeISO 11357-6 Plastics — DSC Crystallinity MeasurementsISO 11358-1 Composite Thermal DecompositionISO 11358-1 Food Thermal Decomposition AnalysisISO 11358-1 Plastics — TGA General PrinciplesISO 11358-1 Thermal Stability TestingISO 11358-2 Plastics — TGA Decomposition ProfilesISO 11358-2 Polymer Thermal DegradationISO 11358-3 Plastics — TGA Thermal StabilityISO 11358-4 Plastics — TGA with Gas AnalysisISO 11359-2 Metal Thermal ExpansionISO 11359-2 Metals — TMA Expansion TestingISO 11359-2 Plastics — TMA Determination of Coefficient of Thermal ExpansionISO 11359-3 Plastics — TMA Linear Thermal ExpansionISO 11359-3 Thermal Expansion TestingISO 15911 Coating Thermal BehaviorISO 18246 Battery Material Thermal TestingISO 18927-1 Ceramic Thermal TestingISO 22007-2 Plastics — Thermal Conductivity TestingISO 22007-4 Plastics — Thermal DiffusivityISO 6721-1 Elastomer Dynamic Mechanical TestingISO 6721-1 Plastics — DMA General PrinciplesISO 6721-10 Plastics — DMA Frequency SweepISO 6721-11 Plastics — DMA Creep and Stress RelaxationISO 6721-2 Plastics — DMA Tensile ModeISO 6721-7 Plastics — DMA Temperature SweepISO 7219 Glass Thermal Properties

ASTM E1356 Differential Scanning Calorimetry of Pharmaceuticals Laboratory Testing Service Provided by Eurolab

Standard-Related Information

Differential Scanning Calorimetry (DSC) is a laboratory testing service used to determine the thermal properties of pharmaceutical materials. The ASTM E1356 standard provides guidelines for conducting DSC tests on pharmaceuticals, ensuring consistent and reliable results.

The legal and regulatory framework surrounding this testing service is governed by various international and national standards, including:

  • ISO 204 (2017): Thermal Analysis - Differential Scanning Calorimetry

  • EN 13164:2015: Thermal Analysis - Differential Scanning Calorimetry

  • TSE (Turkish Standards Institution) TS EN 13164:2015

    • The development of standards is a collaborative effort between standard development organizations, such as ASTM International and ISO. These organizations ensure that standards are updated regularly to reflect new technologies and testing methods.

    Standard Requirements and Needs

    ASTM E1356 DSC testing is essential for pharmaceutical manufacturers to ensure the quality and safety of their products. The consequences of not performing this test can be severe, including:

  • Inaccurate thermal properties

  • Reduced product shelf life

  • Compliance issues with regulatory agencies

    • This testing service is required by various industries, including:

  • Pharmaceutical manufacturing

  • Research and development

  • Quality control laboratories

    • The risk factors associated with pharmaceutical products include:

  • Thermal instability

  • Phase transitions

  • Melting points

    • Quality assurance and quality control aspects are critical in DSC testing. This includes:

  • Calibration and validation procedures

  • Sample preparation and handling

  • Testing parameters and conditions

    • Test Conditions and Methodology

    DSC tests involve the following steps:

    1. Sample preparation: The pharmaceutical material is prepared according to the standard.

    2. Instrument calibration: The instrument is calibrated using reference materials.

    3. Test conditions: The testing environment is set up, including temperature, humidity, and pressure control.

    4. Data collection: The DSC test is performed, and data is collected in real-time.

    The testing equipment used for DSC includes:

  • Differential Scanning Calorimeter (DSC)

  • Thermocouples

  • Temperature control units

    • Test Reporting and Documentation

    Test results are documented and reported according to the ASTM E1356 standard. The report format includes:

  • Test conditions

  • Sample information

  • Results summary

  • Data analysis

    • The certification and accreditation aspects of DSC testing involve:

  • Calibration and validation certificates

  • Accreditation from recognized bodies (e.g., ISO 17025)

  • Compliance with regulatory requirements

    • Why This Test Should Be Performed

    Performing ASTM E1356 DSC testing offers numerous benefits, including:

  • Improved product quality and safety

  • Enhanced compliance with regulatory agencies

  • Increased customer confidence and trust

  • Market access and trade facilitation

  • Innovation and research development support

    • Why Eurolab Should Provide This Service

    Eurolab is an expert in providing ASTM E1356 DSC testing services, with:

  • State-of-the-art equipment and facilities

  • Qualified and certified personnel

  • International recognition and partnerships

  • Accreditation from recognized bodies (e.g., ISO 17025)

  • Quality management systems and procedures

    • Additional Information

    Eurolabs capabilities and advantages include:

  • Fast turnaround times and efficient services

  • Competitive pricing and value proposition

  • Technical support and consultation services

  • Customer service and support capabilities

  • Accreditation and certification details

  • International recognition and partnerships

    • Industry-Specific Examples and Case Studies

    Case Study 1: A pharmaceutical manufacturer required ASTM E1356 DSC testing to ensure the thermal stability of their product. Eurolab conducted the test, providing accurate results that improved product shelf life.

    Case Study 2: A research institution used ASTME1356 DSC testing to investigate the thermal properties of a new material. Eurolabs expertise and equipment enabled them to collect reliable data for their study.

    Conclusion

    ASTM E1356 DSC testing is an essential service for pharmaceutical manufacturers, ensuring product quality and safety. Eurolab provides expert testing services, with state-of-the-art equipment, qualified personnel, and international recognition. Performing this test offers numerous benefits, including improved compliance with regulatory agencies, increased customer confidence, and market access.

    References

  • ASTM E1356 (2018): Standard Test Method for Determining the Melting or Softening Temperature of Solder Alloys

  • ISO 204 (2017): Thermal Analysis - Differential Scanning Calorimetry

  • EN 13164:2015: Thermal Analysis - Differential Scanning Calorimetry

    • Appendices

  • ASTM E1356 standard in full

  • ISO 204 standard in full

  • EN 13164 standard in full

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