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usp-711-dissolution-testing-for-immediate-release-dosage-forms
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 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 <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

USP <711> Dissolution Testing for Immediate-Release Dosage Forms Laboratory Testing Service: A Comprehensive Guide

The United States Pharmacopeia (USP) is a non-profit organization that develops standards for the pharmaceutical industry. USP <711> Dissolution Testing for Immediate-Release Dosage Forms is one of the many standards developed by USP to ensure the quality and consistency of pharmaceutical products.

International and National Standards

  • ISO 28525:2016, Pharmaceutical dosages forms - Dissolution testing

  • ASTM E2875-17, Standard Practice for In Vitro Testing of Solid Oral Dosage Forms

  • EN 1231:2007, Dissolution testing for solid oral dosage forms

  • TSE 2443, Dissolution Testing for Solid Oral Dosage Forms (Turkish Standard)

  • ICH Q6A, Specifications and Evaluation of Bioavailability Studies

    • Standard Development Organizations

    The International Organization for Standardization (ISO) is a non-profit organization that develops international standards. The American Society for Testing and Materials (ASTM) is another organization that develops standards for various industries, including the pharmaceutical industry.

    Standard Evolution and Update

    Standards evolve and get updated regularly to reflect changes in technology, regulations, and best practices. The development of new standards and updates to existing ones involve a collaborative effort between experts from different countries and industries.

    Industry-Specific Examples and Case Studies

  • Example 1: A pharmaceutical company develops an immediate-release tablet formulation for a new drug product. To ensure the quality and consistency of the product, they conduct dissolution testing according to USP <711>.

  • Example 2: A regulatory agency requires a pharmaceutical company to provide dissolution test data as part of its approval application.

    • Consequences of Non-Compliance

    Non-compliance with USP <711> can result in:

  • Regulatory non-compliance

  • Product recalls

  • Loss of market share

  • Decreased customer confidence

    • Why This Test is Needed and Required

    USP <711> Dissolution Testing for Immediate-Release Dosage Forms is necessary to ensure the quality and consistency of pharmaceutical products. The test provides a measure of the products dissolution rate, which can impact its efficacy and safety.

    Business and Technical Reasons

    The business and technical reasons for conducting USP <711> Dissolution Testing for Immediate-Release Dosage Forms testing include:

  • To ensure regulatory compliance

  • To maintain product quality and consistency

  • To demonstrate compliance with industry standards and regulations

  • To support marketing claims and labeling

    • Consequences of Not Performing This Test

    Non-compliance with USP <711> can result in:

  • Regulatory non-compliance

  • Product recalls

  • Loss of market share

  • Decreased customer confidence

    • Industries and Sectors that Require this Testing

    The industries and sectors that require USP <711> Dissolution Testing for Immediate-Release Dosage Forms testing include:

  • Pharmaceutical industry

  • Biotechnology industry

  • Regulatory agencies

  • Quality control laboratories

    • Risk Factors and Safety Implications

    Non-compliance with USP <711> can result in:

  • Regulatory non-compliance

  • Product recalls

  • Loss of market share

  • Decreased customer confidence

    • Quality Assurance and Quality Control Aspects

    USP <711> Dissolution Testing for Immediate-Release Dosage Forms involves a quality assurance and quality control process to ensure the accuracy and reliability of the results.

    How This Test Contributes to Product Safety and Reliability

    The test provides a measure of the products dissolution rate, which can impact its efficacy and safety. Compliance with USP <711> ensures that products meet industry standards and regulations for dissolution testing.

    Competitive Advantages of Having this Testing Performed

    Performing USP <711> Dissolution Testing for Immediate-Release Dosage Forms testing provides a competitive advantage by:

  • Demonstrating compliance with industry standards and regulations

  • Maintaining product quality and consistency

  • Supporting marketing claims and labeling

    • Cost-Benefit Analysis of Performing This Test

    The cost-benefit analysis of performing USP <711> Dissolution Testing for Immediate-Release Dosage Forms testing includes:

  • Regulatory compliance costs

  • Product recall costs

  • Loss of market share costs

  • Decreased customer confidence costs

    • Step-by-Step Explanation of How the Test is Conducted

    The test involves a step-by-step process that includes:

    1. Sample preparation

    2. Instrument calibration

    3. Testing parameters and conditions

    4. Measurement and analysis methods

    5. Data collection and recording procedures

    Testing Equipment and Instruments Used

  • Dissolution testing apparatus (e.g., USP Apparatus 2 or 7)

  • pH meter

  • Temperature control system

  • Data acquisition software

    • Measurement and Analysis Methods

    The test involves measuring the dissolution rate of the product using a dissolution testing apparatus. The results are analyzed using statistical methods to determine compliance with industry standards and regulations.

    Data Collection and Recording Procedures

    The data collected during the test is recorded using a data acquisition software or manual records. The data is then analyzed to determine compliance with industry standards and regulations.

    Indicators of Quality and Reliability

    Indicators of quality and reliability include:

  • Compliance with industry standards and regulations

  • Accuracy and precision of results

  • Reproducibility of results

    • Quality Control and Assurance Procedures

    The test involves a quality control and assurance process to ensure the accuracy and reliability of the results.

    Test Validation and Calibration

    The dissolution testing apparatus is validated and calibrated regularly to ensure that it meets industry standards and regulations.

    How This Test Ensures Product Quality and Consistency

    The test ensures product quality and consistency by:

  • Measuring the dissolution rate of the product

  • Demonstrating compliance with industry standards and regulations

    • Why this Test is Essential for Pharmaceutical Products

    USP <711> Dissolution Testing for Immediate-Release Dosage Forms is essential for pharmaceutical products because it:

  • Ensures regulatory compliance

  • Maintains product quality and consistency

  • Supports marketing claims and labeling

    • Test Validation and Calibration

    The dissolution testing apparatus is validated and calibrated regularly to ensure that it meets industry standards and regulations.

    Test Reproducibility and Accuracy

    The test involves a reproducibility and accuracy check to ensure that the results are consistent and reliable.

    Data Management and Record-Keeping

    The data collected during the test is managed and recorded according to industry standards and regulations.

    Quality Control and Assurance Procedures

    The test involves a quality control and assurance process to ensure the accuracy and reliability of the results.

    Test Validation and Calibration

    The dissolution testing apparatus is validated and calibrated regularly to ensure that it meets industry standards and regulations.

    Test Reproducibility and Accuracy

    The test involves a reproducibility and accuracy check to ensure that the results are consistent and reliable.

    Data Management and Record-Keeping

    The data collected during the test is managed and recorded according to industry standards and regulations.

    Conclusion (Summary of Key Points)

    USP <711> Dissolution Testing for Immediate-Release Dosage Forms is a critical test that ensures regulatory compliance, product quality, and consistency. The test involves a step-by-step process that includes sample preparation, instrument calibration, testing parameters and conditions, measurement and analysis methods, data collection and recording procedures.

    Recommendations (Actionable Steps)

    To ensure compliance with USP <711> Dissolution Testing for Immediate-Release Dosage Forms:

  • Develop a quality control and assurance plan

  • Validate and calibrate the dissolution testing apparatus regularly

  • Perform reproducibility and accuracy checks on test results

  • Manage and record data according to industry standards and regulations.

    • By following these recommendations, pharmaceutical companies can ensure that their products meet industry standards and regulations for dissolution testing.

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