EUROLAB
usp-2078-dissolution-of-floating-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 <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 <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 <2078> Dissolution of Floating Tablets Laboratory Testing Service: A Comprehensive Guide

As the pharmaceutical industry continues to evolve, ensuring the quality and efficacy of medicinal products has become increasingly important. One critical aspect of this is laboratory testing, specifically the dissolution test for floating tablets as per USP <2078>. In this comprehensive guide, we will delve into the world of USP <2078> Dissolution of Floating Tablets laboratory testing services provided by Eurolab.

Standard-Related Information

The United States Pharmacopeia (USP) is a non-profit organization that develops standards for pharmaceuticals and related products. USP <2078> Dissolution of Floating Tablets testing is one such standard that ensures the quality and performance of floating tablets used in various medicinal applications.

Relevant Standards

  • ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for cytotoxicity

  • ASTM E2896-13 Standard Practice for In Vitro Testing of Bioabsorbable Materials

  • EN ISO 10993-12:2012 Biological evaluation of medical devices Part 12: Sample preparation and reference materials

  • TSE (Turkish Standards Institution) EN ISO 10993-12

    • Legal and Regulatory Framework

    The USP <2078> Dissolution of Floating Tablets testing is governed by regulatory agencies worldwide, including the United States Food and Drug Administration (FDA), European Medicines Agency (EMA), and World Health Organization (WHO). Compliance with these regulations ensures the safety and efficacy of medicinal products.

    Standard Development Organizations

    Standard development organizations play a vital role in creating and updating standards. These organizations include:

  • International Organization for Standardization (ISO)

  • American Society for Testing and Materials (ASTM)

  • European Committee for Standardization (CEN)

    • Standard Evolution and Updates

    Standards evolve over time as new technologies and research emerge. Eurolab stays up-to-date with the latest developments to ensure compliance with current regulations.

    Specific Standard Numbers and Scope

  • USP <2078> Dissolution of Floating Tablets testing: Ensures the quality and performance of floating tablets.

  • ISO 10993-5:2009: Biological evaluation of medical devices - Part 5: Tests for cytotoxicity

  • ASTM E2896-13: Standard Practice for In Vitro Testing of Bioabsorbable Materials

    • Industry-Specific Compliance Requirements

    Each industry has its specific compliance requirements. For example:

  • Pharmaceuticals: Compliant with USP <2078> Dissolution of Floating Tablets testing.

  • Medical Devices: Compliant with ISO 10993-5:2009 and ASTM E2896-13.

    • Standard Requirements and Needs

    USP <2078> Dissolution of Floating Tablets testing is essential for ensuring the quality and performance of floating tablets. This section will explain why this specific test is needed and required, as well as the business and technical reasons for conducting it.

    Why This Test Is Needed

    Floating tablets require a specific dissolution profile to ensure their efficacy and safety. USP <2078> Dissolution of Floating Tablets testing ensures that these products meet regulatory requirements.

    Business and Technical Reasons

  • Ensures product quality and performance.

  • Compliant with regulatory agencies worldwide.

  • Supports innovation and research development.

    • Consequences of Not Performing This Test

    Not performing this test can lead to:

  • Non-compliance with regulations.

  • Product recalls and market withdrawals.

  • Loss of customer confidence and trust.

    • Industries and Sectors That Require This Testing

    This testing is required for various industries, including:

  • Pharmaceuticals

  • Medical Devices

  • Biotechnology

  • Cosmetics

    • Risk Factors and Safety Implications

    Not performing this test can lead to safety risks, such as:

  • Ineffective or non-functional products.

  • Exposure to cytotoxicity.

    • Quality Assurance and Quality Control Aspects

    Eurolab ensures quality assurance and quality control through:

  • Accreditation and certification by recognized bodies.

  • Implementation of ISO 17025:2017 (General requirements for the competence of testing and calibration laboratories).

    • Contribution to Product Safety and Reliability

    This test contributes to product safety and reliability by ensuring that products meet regulatory requirements.

    Competitive Advantages

    Performing this test provides competitive advantages, including:

  • Compliance with regulations.

  • Innovation and research development support.

  • Environmental and sustainability considerations.

    • Test Conditions and Methodology

    This section will provide a detailed explanation of the testing conditions and methodology used in USP <2078> Dissolution of Floating Tablets testing.

    Testing Equipment and Instruments

    Eurolab uses state-of-the-art equipment and instruments, including:

  • Dissolution apparatus.

  • pH meters.

  • Spectrophotometers.

    • Testing Environment Requirements

    The testing environment must meet specific requirements, including:

  • Temperature: 25C 1C.

  • pH: 6.5 0.1.

    • Sample Preparation and Reference Materials

    Samples are prepared according to ISO 10993-12:2012. Reference materials are used for calibration purposes.

    Dissolution Profile Evaluation

    The dissolution profile is evaluated based on the following parameters:

  • Percentage of dissolved drug.

  • Time to reach maximum dissolution.

    • Test Results and Reporting

    This section will explain how test results are reported and interpreted.

    Test Report Format

    Eurolab reports results in a standardized format, including:

  • Dissolution profile graph.

  • Summary table.

  • Conclusion.

    • Interpretation of Results

    Results are interpreted based on the dissolution profile, and deviations from regulatory requirements are noted.

    Conclusion

    USP <2078> Dissolution of Floating Tablets testing is essential for ensuring the quality and performance of floating tablets. Eurolab provides comprehensive laboratory testing services to support innovation and research development in various industries.

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