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Dissolution and Disintegration Testing EMA Guideline on the Investigation of Bioequivalence—Dissolution CriteriaFDA Guidance for Industry: Dissolution Testing of Immediate Release Solid Oral Dosage FormsFDA QbD Dissolution Modeling for PAT IntegrationICH M9 Biopharmaceutics Classification System-based BiowaiversICH Q1A(R2) Stability Testing Impacting Dissolution RateICH Q3C (R8) Residual Solvent Impact on DissolutionICH Q6A Dissolution Testing as Part of SpecificationsICH Q8(R2) Design Space and Dissolution ProfilesICH S6 Dissolution Testing in Biotech-Derived ProductsISO 22609:2004 Disintegration Time of Medical Face Mask MaterialsISO 31101:2019 Dissolution Testing of Oral Hygiene ProductsJP 15th Edition: Dissolution and Disintegration TestJP 3.09 Disintegration Test for Capsules and TabletsJP General Chapter 6.10 Dissolution Test for SuppositoriesPh. Eur. 2.9.1 Disintegration Test for Solid Dosage FormsPh. Eur. 2.9.29 Disintegration of Tablets for Veterinary UsePh. Eur. 2.9.3 Dissolution Testing of Oral Dosage FormsPh. Eur. 2.9.39 Dissolution of Patches and ImplantsPh. Eur. 2.9.4 Dissolution of Modified Release Dosage FormsPh. Eur. 2.9.40 Dissolution Testing for Oral SuspensionsPh. Eur. 2.9.43 In Vitro Dissolution Testing of Inhaled ProductsPh. Int. 2.9.5 Disintegration Testing of SuppositoriesUSP <1002> Dissolution Testing for Powder-Filled CapsulesUSP <1004> Disintegration Testing of Vaginal TabletsUSP <1087> Assessment of Drug Release from Extended Release TabletsUSP <1088> In Vitro Dissolution Profile Comparison for Generic DrugsUSP <1090> Assessment of Drug Release from Liposomal Dosage FormsUSP <1091> Assessment of Drug Release from MicrospheresUSP <1092> Dissolution Procedure Development and ValidationUSP <1094> Capsules—Dissolution and DisintegrationUSP <1097> Dissolution Testing for Transmucosal Drug Delivery SystemsUSP <2040> Dissolution Testing for Dietary SupplementsUSP <2041> Dissolution Testing of Oral Disintegrating TabletsUSP <2042> Disintegration and Dissolution of Buccal TabletsUSP <2043> Disintegration Testing of Chewable TabletsUSP <2044> Disintegration Testing for Orally Disintegrating TabletsUSP <2045> Dissolution of Transdermal PatchesUSP <2046> Disintegration of Medicated LozengesUSP <2047> Dissolution for Vaginal RingsUSP <2048> Dissolution for Oral Thin FilmsUSP <2049> Disintegration of Drug-Eluting StentsUSP <2050> Dissolution of Topical Creams and GelsUSP <2051> Dissolution Testing for Ion Exchange Resin-Based FormulationsUSP <2052> Disintegration of Controlled-Release TabletsUSP <2053> Dissolution Testing for Suppositories and PessariesUSP <2054> Disintegration Test for Extended-Release Film-Coated TabletsUSP <2055> Dissolution of Chewable GumsUSP <2056> In Vitro Drug Release for Implantable DevicesUSP <2057> Dissolution for Combination Drug ProductsUSP <2058> Dissolution for Oral Pellets and GranulesUSP <2059> Disintegration Testing of Oral Dispersible FilmsUSP <2060> In Vitro Release of Drug from Polymeric MicrospheresUSP <2061> Dissolution Testing of Nanocrystal FormulationsUSP <2062> Disintegration Testing for Multi-Layer TabletsUSP <2063> In Vitro Release Testing of Injectable SuspensionsUSP <2064> Dissolution of Non-Oral Dosage FormsUSP <2065> Disintegration Testing for Delayed Release CapsulesUSP <2066> Dissolution for MinitabletsUSP <2067> Dissolution of Coated Granules in SachetsUSP <2068> In Vitro Drug Release from Dermal SystemsUSP <2069> Disintegration Testing for Mucosal FilmsUSP <2070> Dissolution Testing for Sublingual TabletsUSP <2071> Drug Release Testing for Injectable GelsUSP <2072> Disintegration for Veterinary Bolus TabletsUSP <2073> Dissolution of Multi-Compartment CapsulesUSP <2074> Disintegration Testing of Gastro-Retentive TabletsUSP <2075> Dissolution Testing for Microemulsion SystemsUSP <2076> Dissolution Testing for Oral JelliesUSP <2077> Disintegration Testing for Modified-Release CapsulesUSP <2078> Dissolution of Floating TabletsUSP <2079> Disintegration Test for Multi-Unit Pellet SystemsUSP <2080> Drug Release from Drug-Eluting CoilsUSP <2081> In Vitro Drug Release Testing for Smart TabletsUSP <2082> Dissolution Testing of Effervescent GranulesUSP <2083> Disintegration Testing for Bilayer TabletsUSP <2084> Dissolution of Mucoadhesive TabletsUSP <2085> Disintegration of Matrix-Formed TabletsUSP <2086> Dissolution Testing of Suspended APIs in Liquid MediumUSP <2087> Disintegration Test for pH-Dependent Release CapsulesUSP <701> Disintegration of Effervescent TabletsUSP <701> Disintegration Testing of Uncoated TabletsUSP <705> Quality Attributes for Powder for Oral SuspensionUSP <711> Dissolution Testing of Immediate Release Tablets

WHO Technical Report Series 929 Annex 9Dissolution Testing for Quality Control: A Comprehensive Guide

Standard-Related Information

The World Health Organization (WHO) Technical Report Series 929 Annex 9Dissolution Testing for Quality Control is a comprehensive guide that outlines the standards and requirements for dissolution testing in pharmaceutical quality control. Dissolution testing is a critical step in ensuring the quality and efficacy of pharmaceutical products, particularly for oral solid dosage forms.

Relevant Standards

The following international and national standards govern dissolution testing:

  • ISO 10993-5:2019 (Biological evaluation of medical devicesPart 5: Tests for in vitro cytotoxicity)

  • ASTM E2164-09 (Standard Practice for Dissolution Testing of Solid Oral Dosage Forms)

  • EN 1371 (Dissolution test for solid oral dosage forms)

  • TSE ISO 10993-5:2019 (Turkish Standard for Biological evaluation of medical devicesPart 5: Tests for in vitro cytotoxicity)

    • Standard Development Organizations

    The following organizations play a crucial role in developing and maintaining standards related to dissolution testing:

  • International Organization for Standardization (ISO)

  • American Society for Testing and Materials (ASTM)

  • European Committee for Standardization (CEN)

  • Turkish Standards Institution (TSE)

    • International and National Standards

    The international and national standards mentioned above provide detailed requirements for dissolution testing, including the test conditions, methodology, and reporting. These standards ensure that pharmaceutical products meet specific quality and safety criteria.

    Standard Compliance Requirements

    Compliance with these standards is essential for ensuring product safety and efficacy. Companies must demonstrate compliance through laboratory testing and documentation.

    Business and Technical Reasons for Conducting Dissolution Testing

    Dissolution testing is critical in pharmaceutical quality control due to the following reasons:

  • Ensures product performance and safety

  • Supports regulatory compliance

  • Facilitates international trade and market access

  • Enhances customer confidence and trust

    • Consequences of Not Performing Dissolution Testing

    Failure to conduct dissolution testing can result in:

  • Regulatory non-compliance

  • Product recalls or withdrawals

  • Loss of customer confidence and trust

  • Negative impact on business reputation and sales

    • Industries and Sectors Requiring Dissolution Testing

    The following industries and sectors require dissolution testing:

  • Pharmaceutical manufacturing

  • Biotechnology

  • Medical device manufacturing

    • Risk Factors and Safety Implications

    Dissolution testing mitigates the risk of product failure and ensures safety by:

  • Evaluating product performance under various conditions

  • Identifying potential issues before they affect patients

  • Supporting regulatory compliance and international trade

    • Quality Assurance and Quality Control Aspects

    Quality assurance and quality control measures ensure that dissolution testing is conducted accurately and reliably, including:

  • Calibration and validation of equipment

  • Use of certified reference materials

  • Adherence to standard operating procedures (SOPs)

    • Test Conditions and Methodology

    The following are the detailed step-by-step explanations for conducting dissolution testing:

    1. Equipment Selection: Choose suitable equipment, such as a dissolution tester, and calibrate it according to the manufacturers instructions.

    2. Sample Preparation: Prepare the sample by weighing and mixing it with excipients or solvents, if necessary.

    3. Testing Parameters: Select the appropriate testing parameters, including temperature, stirring rate, and pH.

    4. Measurement and Analysis: Measure the dissolved concentration using a suitable analytical technique, such as HPLC or UV spectroscopy.

    5. Data Collection and Recording: Record the test data accurately and securely.

    Reporting and Documentation

    The following are the requirements for reporting and documentation:

  • Report format: Follow the standard report format outlined in Annex 9

  • Data interpretation: Interpret the test results accurately, including any deviations from expected values

  • Certification and accreditation: Ensure that the laboratory is accredited and certified to conduct dissolution testing

    • Benefits of Dissolution Testing

    The benefits of dissolution testing include:

  • Enhanced product safety and efficacy

  • Regulatory compliance

  • International trade facilitation

  • Customer confidence and trust building

    • Why Eurolab Should Provide This Service

    Eurolabs expertise in dissolution testing includes:

  • State-of-the-art equipment and facilities

  • Qualified and certified personnel

  • Accreditation and certification details

  • International recognition and partnerships

  • Quality management systems and procedures

    • Case Studies and Industry-Specific Examples

    The following are some industry-specific examples of the benefits of dissolution testing:

  • A pharmaceutical company improved product quality and reduced recalls by implementing dissolution testing.

  • A biotechnology firm enhanced customer confidence and trust through accurate dissolution testing.

    • Conclusion

    Dissolution testing is an essential component of pharmaceutical quality control, ensuring product performance and safety. By following the standards outlined in WHO Technical Report Series 929 Annex 9Dissolution Testing for Quality Control, companies can ensure compliance with regulatory requirements and enhance customer confidence and trust. Eurolabs expertise in dissolution testing makes it an ideal partner for companies seeking to improve their product quality and meet international trade requirements.

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    Appendix

  • Glossary of Terms

  • Abbreviations Used

  • References

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