EUROLAB
ep-295-hardness-of-tablets-measurement
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 2.9.7 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 2.9.5 Hardness of Tablets Measurement Laboratory Testing Service Provided by Eurolab

The European Pharmacopoeia (EP) is a collection of standards for the quality control of medicinal products, including tablets. The EP 2.9.5 standard specifies the requirements for measuring the hardness of tablets, which is an essential parameter for ensuring product safety and efficacy.

Legal and Regulatory Framework

The EP 2.9.5 standard is governed by the European Pharmacopoeia Commission (CPhE) and is published by the Council of Europe. The standard is based on the principles outlined in the International Conference on Harmonization (ICH) guidelines for pharmaceutical quality control. Compliance with this standard is mandatory for all medicinal products intended for human use in the EU.

International and National Standards

The EP 2.9.5 standard is aligned with international standards, including:

  • ISO 14538:2008(E): Pharmaceutical dosages - Hardness testing of tablets

  • ASTM E2233-07: Standard Test Method for Determining the Hardness of Tablets

    • National standards that apply to this specific laboratory test include:

  • EN ISO 14538:2008 (E)

  • TSE 1474:2011 (Turkey)

    • Standard Development Organizations

    The European Pharmacopoeia Commission (CPhE) is responsible for developing and maintaining the EP standards. The CPhE works closely with other standard development organizations, including:

  • International Organization for Standardization (ISO)

  • American Society for Testing and Materials (ASTM)

  • Turkish Standards Institution (TSE)

    • Evolution of Standards

    Standards evolve over time to reflect advances in technology and changes in regulatory requirements. New standards are developed through a collaborative effort involving experts from industry, academia, and regulatory bodies.

    Standard Numbers and Scope

    The EP 2.9.5 standard has the following scope:

  • Hardness testing of tablets using the diametral compression method

  • Measurement of tablet hardness using a hardness tester

    • Industry-Specific Requirements for Standard Compliance

    Compliance with this standard is mandatory for all medicinal products intended for human use in the EU. However, specific industries may have additional requirements, such as:

  • Pharmaceutical industry: EP 2.9.5 compliance is required for all tablets intended for human use.

  • Cosmetic industry: Similar standards apply to tablet-like products used in cosmetics.

    • The hardness of tablets is a critical parameter that affects product stability, dissolution rate, and bioavailability. Non-compliance with this standard can lead to suboptimal product performance, patient safety issues, and regulatory non-compliance.

    Business and Technical Reasons for Conducting EP 2.9.5 Hardness of Tablets Measurement Testing

    Conducting EP 2.9.5 hardness testing is essential for:

  • Ensuring product stability and shelf life

  • Optimizing tablet formulation and processing conditions

  • Maintaining patient safety and efficacy

  • Meeting regulatory requirements

    • Consequences of Not Performing This Test

    Non-compliance with this standard can lead to:

  • Regulatory non-compliance and fines

  • Product recalls and damage to reputation

  • Patient safety issues and health risks

  • Suboptimal product performance and reduced bioavailability

    • Industries and Sectors that Require This Testing

    The following industries require EP 2.9.5 hardness testing:

  • Pharmaceutical industry: All tablets intended for human use must comply with this standard.

  • Cosmetic industry: Similar standards apply to tablet-like products used in cosmetics.

    • Risk Factors and Safety Implications

    Non-compliance with this standard can lead to:

  • Patient safety issues due to suboptimal product performance

  • Health risks associated with reduced bioavailability

    • Quality Assurance and Quality Control Aspects

    Eurolab ensures that all testing is performed according to EP 2.9.5 requirements, including:

  • Use of calibrated equipment and instruments

  • Trained personnel with experience in hardness testing

  • Regular quality control measures to ensure accuracy and precision

    • Contributions to Product Safety and Reliability

    EP 2.9.5 hardness testing contributes to product safety and reliability by ensuring that tablets meet the required standards for hardness.

    Competitive Advantages of Having This Testing Performed

    Conducting EP 2.9.5 hardness testing provides a competitive advantage in:

  • Ensuring compliance with regulatory requirements

  • Maintaining patient safety and efficacy

  • Optimizing tablet formulation and processing conditions

    • Cost-Benefit Analysis of Performing This Test

    The benefits of conducting EP 2.9.5 hardness testing far outweigh the costs, including:

  • Reduced risk of regulatory non-compliance and fines

  • Improved product stability and shelf life

  • Enhanced patient safety and efficacy

    • The following section provides a detailed explanation of how to conduct EP 2.9.5 hardness testing.

    Measurement of Tablet Hardness

    Tablet hardness is measured using a hardness tester, which applies a compressive force to the tablet until it breaks or deforms.

    Calibration and Verification

    The hardness tester must be calibrated and verified regularly to ensure accuracy and precision.

    Procedure for Conducting EP 2.9.5 Hardness Testing

    1. Prepare the tablet samples according to the EP 2.9.5 requirements.

    2. Measure the tablet hardness using a hardness tester.

    3. Record the results and calculate the average hardness value.

    Quality Control Measures

    Eurolab ensures that all testing is performed according to EP 2.9.5 requirements, including:

  • Use of calibrated equipment and instruments

  • Trained personnel with experience in hardness testing

  • Regular quality control measures to ensure accuracy and precision

    • Test Results and Reporting

    The test results are reported as the average hardness value, along with the standard deviation.

    Conclusion

    EP 2.9.5 hardness testing is an essential parameter for ensuring product safety and efficacy. Non-compliance with this standard can lead to regulatory non-compliance, patient safety issues, and reduced bioavailability. Conducting EP 2.9.5 hardness testing provides a competitive advantage in ensuring compliance with regulatory requirements, maintaining patient safety and efficacy, and optimizing tablet formulation and processing conditions.

    Appendix

    The following appendix provides additional information on the EP 2.9.5 standard, including:

  • Standard text

  • Scope and applicability

  • Measurement principles and methods

  • Calibration and verification procedures

    • Please note that this is a sample guide and should not be used as a substitute for the actual EP 2.9.5 standard.

    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