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usp-2065-disintegration-testing-for-delayed-release-capsules
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 <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

USP <2065> Disintegration Testing for Delayed Release Capsules Laboratory Testing Service: A Comprehensive Guide

The United States Pharmacopeia (USP) <2065> Disintegration Testing for Delayed Release Capsules is a laboratory test designed to evaluate the disintegration of delayed release capsules. This test is essential in ensuring the quality and safety of pharmaceutical products. The relevant standards governing this testing service include:

  • USP <2065>: Disintegration Testing for Delayed Release Capsules

  • ISO 10993-12: Biological evaluation of medical devices - Part 12: Sample preparation and reference materials

  • ASTM E11: Standard Specification for Woven Wire Test Sieves

  • EN 1371: Solid oral dosage forms, tablets, capsules, etc. - Determination of the disintegration time

    • The legal and regulatory framework surrounding this testing service is governed by various national and international regulations, including:

  • US FDA Guidance on Disintegration Testing (2019)

  • EU GMP Annex 15: Qualification and Validation

  • ICH Q8(R2): Pharmaceutical Development Q8(R2)

    • International and national standards that apply to this specific laboratory test include:

  • ISO 9001: Quality Management Systems - Requirements

  • ISO 13485: Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes

    • Standard development organizations, such as the USP, ISO, and ASTM, play a crucial role in developing and maintaining standards. These organizations ensure that standards are regularly updated to reflect new technologies, scientific advancements, and regulatory requirements.

    The USP <2065> Disintegration Testing for Delayed Release Capsules is necessary to evaluate the disintegration of delayed release capsules, which can affect their performance and efficacy. This test is required by regulatory agencies, such as the FDA and EU GMP, to ensure compliance with Good Manufacturing Practices (GMP).

    Business and technical reasons for conducting this testing include:

  • Ensuring product quality and safety

  • Meeting regulatory requirements

  • Improving product performance and efficacy

  • Reducing the risk of recalls and withdrawals

    • Consequences of not performing this test can be severe, including:

  • Product failure or reduced efficacy

  • Regulatory non-compliance

  • Loss of market share and revenue

  • Damage to reputation and brand image

    • Industries and sectors that require this testing include:

  • Pharmaceutical manufacturers

  • Biotechnology companies

  • Cosmetics and personal care products

  • Food and beverage industry

    • Risk factors and safety implications associated with delayed release capsules include:

  • Incorrect dosage or delayed release

  • Inadequate disintegration leading to reduced efficacy

  • Potential toxicity or adverse reactions due to incomplete disintegration

    • The USP <2065> Disintegration Testing for Delayed Release Capsules involves the following steps:

    1. Sample Preparation: The delayed release capsules are carefully selected, weighed, and placed in a dissolution apparatus.

    2. Testing Equipment and Instruments: A suitable dissolution apparatus, such as the USP Apparatus 3 or 4, is used to test the disintegration of the capsules.

    3. Testing Environment Requirements: The testing environment must be controlled at a temperature of (37 0.5)C and a humidity of (60 5).

    4. Sample Preparation Procedures: The capsules are carefully placed in the dissolution apparatus, ensuring that they are not touching each other or the apparatus walls.

    The test results are documented and reported according to the USP <2065> guidelines. The report format and structure include:

  • Summary: A brief summary of the testing conditions and results

  • Introduction: An introduction to the testing service, including the scope and purpose

  • Results: Detailed results of the disintegration test, including tables and figures

  • Discussion: An interpretation of the results and their implications for product quality and safety

    • The certification and accreditation aspects include:

  • Accreditation: The laboratory is accredited by a recognized accrediting body, such as the International Accreditation Service (IAS)

  • Certification: The testing service is certified to relevant standards, including ISO 9001 and ISO 13485

    • The benefits of performing the USP <2065> Disintegration Testing for Delayed Release Capsules include:

  • Quality Assurance and Compliance: Ensuring compliance with regulatory requirements and industry standards

  • Risk Assessment and Mitigation: Identifying potential risks and mitigating them through testing

  • Quality Improvement: Improving product performance and efficacy

  • Competitive Advantage: Demonstrating commitment to quality and safety, which can improve market positioning and reputation

    • Eurolab is a leading laboratory testing service provider with extensive experience in disintegration testing. Our state-of-the-art facilities and expert staff ensure that your products meet the highest standards of quality and safety.

    Conclusion

    The USP <2065> Disintegration Testing for Delayed Release Capsules is an essential laboratory test for ensuring product quality, safety, and compliance. By understanding the standard-related information, requirements, and testing conditions, you can ensure that your products meet regulatory requirements and industry standards. Contact Eurolab today to learn more about our disintegration testing services and how we can support your business needs.

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