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Dissolution and Disintegration Testing EMA Guideline on the Investigation of Bioequivalence—Dissolution CriteriaFDA 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 TabletsWHO Technical Report Series 929 Annex 9—Dissolution Testing for Quality Control

Comprehensive Guide to FDA Guidance for Industry: Dissolution Testing of Immediate Release Solid Oral Dosage Forms Laboratory Testing Service

Provided by Eurolab

The FDA Guidance for Industry: Dissolution Testing of Immediate Release Solid Oral Dosage Forms is a comprehensive set of guidelines that outline the requirements for dissolution testing of immediate release solid oral dosage forms. This guide provides an overview of the relevant standards, legal and regulatory framework, international and national standards, standard development organizations, standard evolution, and compliance requirements.

Relevant Standards

The following standards are relevant to FDA Guidance for Industry: Dissolution Testing of Immediate Release Solid Oral Dosage Forms:

  • USP <711>: Dissolution

  • USP <724>: Tablet Friability

  • ASTM E2876-11: Standard Test Method for Determining the Rate of Release of a Drug Substance from an In Vitro Device

  • ISO 4561:2013: Tablets Determination of crushing strength

    • Legal and Regulatory Framework

    The FDA Guidance for Industry: Dissolution Testing of Immediate Release Solid Oral Dosage Forms is based on the following regulatory requirements:

  • 21 CFR Part 211: Current Good Manufacturing Practice (cGMP) in Manufacturing, Processing, Packing, or Holding of Drugs

  • 21 CFR Part 312: Investigational New Drug Application

    • International and National Standards

    The following international and national standards apply to FDA Guidance for Industry: Dissolution Testing of Immediate Release Solid Oral Dosage Forms:

  • USP <711>: USP Standard for dissolution testing

  • EN ISO 4561:2013: European standard for tablets Determination of crushing strength

  • TSE (Turkey) EN ISO 4561:2013: Turkish standard for tablets Determination of crushing strength

    • Standard Development Organizations

    The following standard development organizations are responsible for the development and maintenance of standards related to FDA Guidance for Industry: Dissolution Testing of Immediate Release Solid Oral Dosage Forms:

  • United States Pharmacopeia (USP)

  • American Society for Testing and Materials (ASTM)

  • International Organization for Standardization (ISO)

    • Standard Evolution

    Standards evolve over time due to advances in technology, changes in regulatory requirements, or new scientific knowledge. The following are some of the ways standards evolve:

  • Revision: Standards are revised to reflect changes in regulatory requirements or advances in technology.

  • New Edition: New editions of standards are published to reflect changes in scientific knowledge or new technologies.

    • Compliance Requirements

    Compliance with FDA Guidance for Industry: Dissolution Testing of Immediate Release Solid Oral Dosage Forms requires:

  • Testing: Testing must be performed according to the guidelines outlined in the FDA guidance.

  • Documentation: Documentation must be maintained to demonstrate compliance with regulatory requirements.

    • The following sections explain why this specific test is needed, required, and conducted.

    Business and Technical Reasons for Conducting Testing

    Dissolution testing of immediate release solid oral dosage forms is required by regulatory agencies due to the importance of ensuring product safety and efficacy. The business reasons for conducting dissolution testing include:

  • Product Safety: Ensuring that products are safe for consumption.

  • Efficacy: Ensuring that products work as intended.

    • Consequences of Not Performing Testing

    Consequences of not performing dissolution testing include:

  • Regulatory Non-Compliance: Failure to comply with regulatory requirements can result in fines, penalties, or even product recalls.

  • Product Safety Issues: Failure to ensure product safety can result in adverse events or harm to consumers.

    • Industries and Sectors that Require Testing

    The following industries and sectors require dissolution testing of immediate release solid oral dosage forms:

  • Pharmaceutical Industry

  • Cosmetics Industry

  • Food Industry

    • Risk Factors and Safety Implications

    Risk factors associated with dissolution testing include:

  • Operator Error: Incorrect operator error can result in inaccurate test results.

  • Equipment Failure: Equipment failure can result in inaccurate or inconsistent test results.

    • Quality Assurance and Control Aspects

    Quality assurance and control aspects related to dissolution testing include:

  • Calibration: Calibration of equipment is essential to ensure accuracy and consistency.

  • Validation: Validation of test procedures ensures that tests are accurate and reliable.

    • Contribution to Product Safety and Reliability

    Dissolution testing contributes to product safety and reliability by ensuring that products work as intended and are safe for consumption.

    Competitive Advantages of Having Testing Performed

    Performing dissolution testing provides competitive advantages, including:

  • Product Differentiation: Demonstrating compliance with regulatory requirements can differentiate a companys products from those of competitors.

  • Customer Confidence: Demonstrating product safety and efficacy can build customer confidence.

    • The following sections outline the test conditions and methodology for conducting dissolution testing of immediate release solid oral dosage forms.

    Test Apparatus

    The following apparatus is required for conducting dissolution testing:

  • Dissolution Vessel: A vessel designed to hold the sample and solvent.

  • Stirrer: A stirrer that ensures uniform mixing of the sample and solvent.

  • Pump: A pump that supplies the solvent to the dissolution vessel.

    • Test Procedure

    The following test procedure is outlined in FDA Guidance for Industry: Dissolution Testing of Immediate Release Solid Oral Dosage Forms:

    1. Sample Preparation: The sample must be prepared according to the manufacturers instructions.

    2. Dissolution Vessel Preparation: The dissolution vessel must be prepared according to the manufacturers instructions.

    3. Solvent Preparation: The solvent must be prepared according to the manufacturers instructions.

    4. Stirring: The stirrer must be adjusted to ensure uniform mixing of the sample and solvent.

    5. Pumping: The pump must be adjusted to supply the solvent to the dissolution vessel at a controlled rate.

    Conclusion

    In conclusion, FDA Guidance for Industry: Dissolution Testing of Immediate Release Solid Oral Dosage Forms provides a comprehensive set of guidelines for conducting dissolution testing of immediate release solid oral dosage forms. Compliance with regulatory requirements is essential to ensure product safety and efficacy. Performing dissolution testing provides competitive advantages, including product differentiation and customer confidence.

    Contact Us

    For more information on FDA Guidance for Industry: Dissolution Testing of Immediate Release Solid Oral Dosage Forms laboratory testing services, please contact us at:

    Email: infoeurolab.com(mailto:infoeurolab.com)

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    About Eurolab

    Eurolab is a leading provider of laboratory testing services for the pharmaceutical, cosmetics, and food industries. Our experienced team provides high-quality testing services to ensure compliance with regulatory requirements.

    This comprehensive guide has provided an overview of FDA Guidance for Industry: Dissolution Testing of Immediate Release Solid Oral Dosage Forms laboratory testing services.

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