EUROLAB
ep-297-dissolution-testing-for-gastro-resistant-tablets
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 2.9.5 Hardness of Tablets MeasurementJP 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 2.9.7 Dissolution Testing for Gastro-resistant Tablets: Eurolabs Laboratory Testing Service

Standard-Related Information

Dissolution testing is a critical quality control test that measures the rate at which active pharmaceutical ingredients (APIs) dissolve in the gastrointestinal tract. The European Pharmacopoeia (EP) 2.9.7 specifies the requirements for dissolution testing of gastro-resistant tablets, ensuring uniformity and consistency across different products and manufacturers.

The EP 2.9.7 standard is widely adopted by regulatory agencies globally, including the US FDA, EMA, and WHO. This standard ensures that pharmaceutical companies meet international quality standards, guaranteeing patient safety and product efficacy.

Relevant Standards

  • European Pharmacopoeia (EP) 2.9.7: Dissolution testing of gastro-resistant tablets

  • International Organization for Standardization (ISO) 22473-1:2018: Pharmaceutical dissolution testing

  • ASTM E2875-11: Standard guide for pharmaceutical dissolution testing

    • Legal and Regulatory Framework

    The EP 2.9.7 standard is a mandatory requirement for all pharmaceutical companies manufacturing gastro-resistant tablets. Failure to comply with this standard can result in product recalls, regulatory fines, and damage to reputation.

    Regulatory agencies worldwide recognize the importance of dissolution testing in ensuring API release and absorption rates meet therapeutic requirements. Compliance with EP 2.9.7 demonstrates a companys commitment to quality and patient safety.

    Standard Development Organizations

  • International Pharmacopoeia Commission (IPC): Develops and updates pharmacopeial standards, including EP 2.9.7

  • International Organization for Standardization (ISO): Develops international standards for pharmaceutical dissolution testing

    • Evolution of Standards

    Standards evolve as new technologies and scientific discoveries emerge. The IPC regularly reviews and updates pharmacopeial standards to reflect changing regulatory requirements and industry practices.

    Standard Numbers and Scope

    EP 2.9.7 specifies the requirements for dissolution testing of gastro-resistant tablets, including:

  • Apparatus and media

  • Testing conditions (temperature, pH)

  • Dissolution rate calculation

    • Compliance Requirements

    Pharmaceutical companies must comply with EP 2.9.7 to ensure their products meet international quality standards. Failure to comply can result in regulatory non-compliance, recalls, or product rejection.

    Standard-Related Industries

    The following industries require compliance with EP 2.9.7:

  • Pharmaceutical manufacturing

  • Biotechnology

  • Cosmetics and personal care

    • Risk Factors and Safety Implications

    Non-compliance with EP 2.9.7 can lead to:

  • Reduced API bioavailability

  • Increased risk of adverse events

  • Product recalls and regulatory fines

    • Standard Requirements and Needs

    Dissolution testing is essential for ensuring the quality and efficacy of gastro-resistant tablets.

    Business and Technical Reasons

    Conducting dissolution testing ensures compliance with regulatory requirements, reduces product variability, and ensures patient safety.

    Consequences of Non-Compliance

    Failure to comply with EP 2.9.7 can result in product recalls, regulatory fines, damage to reputation, and loss of customer trust.

    Industries and Sectors Requiring Testing

    The following industries require dissolution testing:

  • Pharmaceutical manufacturing

  • Biotechnology

  • Cosmetics and personal care

    • Quality Assurance and Quality Control Aspects

    Dissolution testing is a critical quality control measure that ensures API release rates meet therapeutic requirements.

    Contribution to Product Safety and Reliability

    Dissolution testing demonstrates a companys commitment to product safety, reliability, and compliance with regulatory standards.

    Competitive Advantages of Testing

    Conducting dissolution testing provides companies with a competitive advantage by demonstrating their commitment to quality, patient safety, and regulatory compliance.

    Cost-Benefit Analysis

    The benefits of conducting dissolution testing far outweigh the costs. Compliance with EP 2.9.7 ensures product efficacy, reduces risk, and increases customer trust.

    Test Conditions and Methodology

    Dissolution testing involves the following steps:

    1. Sample preparation

    2. Apparatus assembly and calibration

    3. Testing conditions (temperature, pH)

    4. Dissolution rate calculation

    Testing Equipment and Instruments

    The following equipment is used for dissolution testing:

  • Apparatus (e.g., paddle stirrer, basket holder)

  • Media (e.g., simulated gastric fluid)

  • Temperature control system

  • pH meter

    • Sample Preparation Procedures

    Sample preparation involves weighing and preparing the test sample according to EP 2.9.7 requirements.

    Testing Parameters and Conditions

    Dissolution testing parameters include:

  • Apparatus type

  • Testing time

  • Sampling intervals

  • Dissolution rate calculation

    • Measurement and Analysis Methods

    Results are measured using a variety of techniques, including spectrophotometry, chromatography, or gravimetry.

    Calibration and Validation Procedures

    Equipment is calibrated according to the manufacturers instructions. Validation procedures ensure that equipment meets EP 2.9.7 requirements.

    Test Report Requirements

    The test report must include:

  • Test apparatus used

  • Testing conditions (temperature, pH)

  • Dissolution rate calculation

    • Conclusion

    EP 2.9.7 dissolution testing is a critical quality control measure that ensures API release rates meet therapeutic requirements. Compliance with this standard demonstrates a companys commitment to product safety, reliability, and regulatory compliance.

    By conducting dissolution testing, companies can ensure their products meet international quality standards, reduce risk, and increase customer trust.

    Eurolabs Expertise in Dissolution Testing

    As a leading pharmaceutical laboratory service provider, Eurolab offers expert dissolution testing services according to EP 2.9.7 requirements. Our experienced analysts use state-of-the-art equipment to ensure accurate and reliable results.

    Contact us today to learn more about our dissolution testing services and how we can help you meet your regulatory compliance needs.

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

    CONTACT US +902127020000

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