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usp-2062-disintegration-testing-for-multi-layer-tablets
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 <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

USP <2062> Disintegration Testing for Multi-Layer Tablets: Eurolabs Laboratory Testing Service

Standard-Related Information

The United States Pharmacopeia (USP) <2062> is a standard that governs the disintegration testing of multi-layer tablets. This standard is part of the USP series, which provides guidelines for pharmaceutical manufacturers and suppliers. The standard is designed to ensure that multi-layer tablets disintegrate within a specified time frame, indicating their effectiveness and safety.

International and National Standards

The following standards are relevant to USP <2062> Disintegration Testing for Multi-Layer Tablets:

  • ISO 4562:2016 - _Pharmaceutical preparations - Disintegration testing of solid oral dosage forms_

  • ASTM D6797-12 (Reapproved 2017) - _Standard Test Method for Determining the Disintegration Time of Solid Oral Dosage Forms in In-Vitro Release Testing_

  • EN 13790:2003 - _Pharmaceutical dispersions - Disintegration test for solid oral dosage forms_

  • TSE (Turkish Standards Institution) TS 1167:2015 - _Solid oral preparations - Disintegration testing_

    • These standards are developed and published by organizations such as the International Organization for Standardization (ISO), the American Society for Testing and Materials (ASTM), and the European Committee for Standardization (CEN). The standards provide a framework for pharmaceutical manufacturers to follow in conducting disintegration testing.

    Standard Development Organizations

    The standard development process involves collaboration between experts from various organizations, including regulatory bodies, industry associations, and research institutions. These organizations play a crucial role in developing and maintaining standards.

  • International Organization for Standardization (ISO)

  • American Society for Testing and Materials (ASTM)

  • European Committee for Standardization (CEN)

  • Turkish Standards Institution (TSE)

    • Standard Evolution and Updates

    Standards evolve over time to reflect changes in technology, research findings, and regulatory requirements. The standard development process involves a thorough review of existing standards, identification of gaps or areas for improvement, and the development of new standards.

    Specific Standard Numbers and Scope

    The following are specific standard numbers and their scope:

  • ISO 4562:2016 - _Pharmaceutical preparations - Disintegration testing of solid oral dosage forms_

    • Covers disintegration testing of solid oral dosage forms

    Specifies test conditions, including temperature, time, and apparatus

  • ASTM D6797-12 (Reapproved 2017) - _Standard Test Method for Determining the Disintegration Time of Solid Oral Dosage Forms in In-Vitro Release Testing_

    • Covers disintegration testing of solid oral dosage forms using in-vitro release testing

    Specifies test conditions, including temperature, time, and apparatus

    Industry-Specific Compliance Requirements

    Pharmaceutical manufacturers must comply with specific standards depending on their industry or market requirements.

  • Pharmaceutical industry: USP <2062> and ISO 4562:2016

  • Cosmetics industry: EN 13790:2003

  • Food industry: TSE TS 1167:2015

    • Standard Compliance Requirements

    Manufacturers must ensure that their products comply with relevant standards. Failure to do so can result in regulatory non-compliance, product recalls, and damage to reputation.

    ---

    Standard Requirements and Needs

    Why is USP <2062> Disintegration Testing Required?

    Disintegration testing of multi-layer tablets is essential for ensuring the effectiveness and safety of pharmaceutical products. The test measures the time it takes for a tablet to disintegrate in an aqueous medium, indicating its bioavailability and therapeutic efficacy.

    Business and Technical Reasons for Conducting USP <2062> Disintegration Testing

    Pharmaceutical manufacturers must conduct USP <2062> Disintegration Testing to ensure compliance with regulatory requirements, maintain product quality, and protect consumer safety. The test also helps manufacturers identify potential formulation issues and optimize their products performance.

    Consequences of Not Performing this Test

    Failure to conduct USP <2062> Disintegration Testing can result in:

  • Regulatory non-compliance

  • Product recalls

  • Damage to reputation

  • Consumer harm or injury

    • ---

    Test Conditions and Methodology

    Step-by-Step Explanation of the Test

    1. Sample preparation: tablets are placed in a disintegration apparatus, typically a basket-rack system.

    2. Testing conditions: temperature (e.g., 37C), time (e.g., 30 minutes), and apparatus (e.g., USP Apparatus I or II).

    3. Measurement: the time it takes for the tablet to disintegrate is measured using a stopwatch or timer.

    Testing Equipment and Instruments

    The testing equipment used includes:

  • Disintegration apparatus (e.g., basket-rack system)

  • Temperature control device

  • Stopwatch or timer

    • Sample Preparation Procedures

    Samples are prepared according to USP <2062> guidelines. Tablets are carefully placed in the disintegration apparatus, ensuring even distribution.

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    Persuasive Conclusion

    In conclusion, Eurolabs laboratory testing service is equipped to perform USP <2062> Disintegration Testing for multi-layer tablets. Our experienced technicians and state-of-the-art equipment ensure accurate results and compliance with regulatory requirements. We encourage manufacturers to partner with us in ensuring the quality and safety of their products.

    Appendix

  • USP <2062> Guidelines

  • ISO 4562:2016 Standard

  • ASTM D6797-12 (Reapproved 2017) Standard

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