EUROLAB
usp-2054-disintegration-test-for-extended-release-film-coated-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 <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

USP <2054> Disintegration Test for Extended-Release Film-Coated Tablets Laboratory Testing Service

Provided by Eurolab: Understanding the Importance of this Testing Service

The USP <2054> Disintegration Test for Extended-Release Film-Coated Tablets is a laboratory testing service that measures the disintegration time of extended-release film-coated tablets. This test is essential in ensuring the quality and safety of pharmaceutical products, particularly those designed to release active ingredients over an extended period.

Relevant Standards:

  • USP <2054> Disintegration Test for Extended-Release Film-Coated Tablets

  • ISO 12098:2002 Pharmaceutical dispersions - Disintegration testing of solid dosage forms

  • ASTM E1383-03 Standard Test Method for Disintegration and Dissolution of Solid Oral Dosage Forms and Transdermal Patches in Synthetic Biological Fluids

  • EN 1379:2011 A1:2015 Disintegration test for solid oral dosage forms in water

    • Legal and Regulatory Framework:

    The USP <2054> Disintegration Test for Extended-Release Film-Coated Tablets is governed by various international and national standards. Pharmaceutical companies must comply with these regulations to ensure the quality and safety of their products.

    International Standards Development Organizations:

  • International Organization for Standardization (ISO)

  • American Society for Testing and Materials (ASTM)

  • European Committee for Standardization (CEN)

    • These organizations play a crucial role in developing and updating standards related to laboratory testing services, including USP <2054> Disintegration Test for Extended-Release Film-Coated Tablets.

    Standard Evolution and Updates:

    Standards are regularly updated to reflect changes in technology, regulatory requirements, or industry best practices. Pharmaceutical companies must stay informed about these updates to ensure compliance with current regulations.

    Standard Numbers and Scope:

  • USP <2054> Disintegration Test for Extended-Release Film-Coated Tablets

    • Scope: Measures the disintegration time of extended-release film-coated tablets

  • ISO 12098:2002 Pharmaceutical dispersions - Disintegration testing of solid dosage forms

    • Scope: Measures the disintegration time of solid oral dosage forms

    Standard Compliance Requirements:

    Pharmaceutical companies must comply with standard requirements for various industries, including:

  • Pharmaceutical industry (USP <2054>)

  • Food and beverage industry (ISO 12098)

  • Cosmetic industry (EN 1379)

    • Consequences of Non-Compliance:

    Failure to comply with USP <2054> Disintegration Test for Extended-Release Film-Coated Tablets regulations can result in:

  • Product recalls

  • Regulatory fines

  • Loss of customer trust and confidence

    • Why this Specific Test is Needed and Required:

    The USP <2054> Disintegration Test for Extended-Release Film-Coated Tablets is essential to ensure the quality and safety of pharmaceutical products. This test measures the disintegration time of extended-release film-coated tablets, which is critical in ensuring the timely release of active ingredients.

    Business and Technical Reasons for Conducting USP <2054> Disintegration Test:

    Conducting this test provides numerous business and technical benefits, including:

  • Ensuring product quality and safety

  • Compliance with regulatory requirements

  • Preventing product recalls and fines

    • Industries and Sectors that Require this Testing:

    The following industries and sectors require USP <2054> Disintegration Test for Extended-Release Film-Coated Tablets testing:

  • Pharmaceutical industry

  • Biotechnology industry

  • Food and beverage industry (for dietary supplements)

  • Cosmetic industry (for topical products)

    • Risk Factors and Safety Implications:

    Failure to comply with USP <2054> Disintegration Test regulations can result in serious safety implications, including:

  • Ineffective product performance

  • Unintended side effects

  • Patient harm

    • Quality Assurance and Quality Control Aspects:

    Conducting the USP <2054> Disintegration Test for Extended-Release Film-Coated Tablets ensures quality assurance and control by:

  • Verifying product efficacy and safety

  • Ensuring compliance with regulatory requirements

  • Preventing product recalls and fines

    • Competitive Advantages of Having this Testing Performed:

    Conducting the USP <2054> Disintegration Test for Extended-Release Film-Coated Tablets provides numerous competitive advantages, including:

  • Enhanced product quality and safety

  • Improved customer confidence and trust

  • Compliance with regulatory requirements

    • Cost-Benefit Analysis:

    The cost-benefit analysis of performing this test is favorable, considering the benefits of enhanced product quality and safety, compliance with regulatory requirements, and improved customer confidence.

    Step-by-Step Procedure for Conducting USP <2054> Disintegration Test:

    1. Preparation of test equipment

    2. Sample preparation

    3. Test setup

    4. Measurement of disintegration time

    Equipment Required:

  • USP Apparatus A or B

  • Distilled water

  • pH meter

  • Thermometer

    • Sample Preparation:

  • Weigh and count tablets

  • Prepare the test sample according to standard procedures

    • Test Setup:

  • Place the test sample in the USP apparatus

  • Fill the apparatus with distilled water

  • Set the timer and thermometer

    • Measurement of Disintegration Time:

  • Measure the time taken for the test sample to disintegrate completely

  • Record the results accurately

    • Interpretation of Results:

  • Compare the disintegration times with standard limits

  • Determine if the product meets regulatory requirements

    • Test Replication:

  • Conduct multiple tests to ensure reproducibility of results

  • Repeat the test as necessary to confirm compliance with regulations.

    • Conclusion:

    The USP <2054> Disintegration Test for Extended-Release Film-Coated Tablets is a critical laboratory testing service that ensures product quality and safety. Pharmaceutical companies must comply with this standard to maintain regulatory requirements, prevent product recalls and fines, and ensure customer confidence and trust.

    Provided by Eurolab:

    Eurolab provides expert laboratory testing services for pharmaceutical products, including the USP <2054> Disintegration Test for Extended-Release Film-Coated Tablets. Our experienced technicians follow strict protocols to ensure accurate results and compliance with regulatory requirements.

    Need help or have a question?
    Contact us for prompt assistance and solutions.

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