EUROLAB
usp-2042-disintegration-and-dissolution-of-buccal-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 <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

USP <2042> Disintegration and Dissolution of Buccal Tablets Laboratory Testing Service

Provided by Eurolab: Ensuring Product Safety and Compliance

The United States Pharmacopeia (USP) is a non-profit organization that sets standards for the quality, purity, strength, and identity of pharmaceuticals. USP <2042> Disintegration and Dissolution of Buccal Tablets is one such standard that governs the testing of buccal tablets, which are designed to be placed in the mouth where they dissolve or disintegrate.

Legal and Regulatory Framework

The USP <2042> standard is a mandatory requirement for pharmaceutical manufacturers, distributors, and regulatory agencies. Failure to comply with this standard can result in product recalls, reputational damage, and financial losses.

International and National Standards

USP <2042> Disintegration and Dissolution of Buccal Tablets testing is governed by the following international and national standards:

  • ISO 11607 (Packaging for Terminally Sterilized Medical Devices)

  • ASTM F2423 (Standard Guide for Selection of Materials for Controlled Release Dosage Forms)

  • EN 13726 (Pharmaceuticals, tablets, buccal)

  • TSE (Turkish Standards Institution) TS 1349 (Buccal Tablets)

    • Standard Development Organizations and Their Role

    The development of standards is a collaborative effort between industry stakeholders, regulatory agencies, and standard development organizations. The following organizations play a crucial role in the development of USP <2042> Disintegration and Dissolution of Buccal Tablets testing:

  • USP (United States Pharmacopeia)

  • ISO (International Organization for Standardization)

  • ASTM (American Society for Testing and Materials)

    • Standard Compliance Requirements

    Pharmaceutical manufacturers, distributors, and regulatory agencies must comply with the following standard compliance requirements for USP <2042> Disintegration and Dissolution of Buccal Tablets testing:

  • Use approved test equipment and instruments

  • Follow specified testing procedures and protocols

  • Maintain accurate records and documentation

  • Ensure quality control measures are in place

    • Standard Evolution and Updates

    Standards evolve over time to reflect advances in technology, changes in regulations, and emerging industry needs. Eurolab stays up-to-date with the latest developments and updates in USP <2042> Disintegration and Dissolution of Buccal Tablets testing.

    Specific Standard Numbers and Scope

    The following standard numbers and scope apply to USP <2042> Disintegration and Dissolution of Buccal Tablets testing:

  • USP 2042: Disintegration and dissolution of buccal tablets

  • ISO 11607: Packaging for terminally sterilized medical devices

  • ASTM F2423: Standard guide for selection of materials for controlled release dosage forms

    • Industry-Specific Examples and Case Studies

    Eurolab has extensive experience in USP <2042> Disintegration and Dissolution of Buccal Tablets testing across various industries, including:

  • Pharmaceutical manufacturing

  • Biotechnology

  • Medical device development

  • Cosmetics and personal care products

    • Why This Specific Test is Needed and Required

    The USP <2042> Disintegration and Dissolution of Buccal Tablets testing is essential to ensure the safety, efficacy, and quality of buccal tablets. The test assesses the ability of the tablet to disintegrate or dissolve in the mouth, which affects its bioavailability and therapeutic effectiveness.

    Business and Technical Reasons for Conducting USP <2042> Disintegration and Dissolution of Buccal Tablets Testing

    Conducting USP <2042> Disintegration and Dissolution of Buccal Tablets testing is critical to:

  • Ensure product safety and efficacy

  • Comply with regulatory requirements

  • Maintain quality control measures

  • Enhance customer confidence and trust

    • Consequences of Not Performing This Test

    Failure to conduct USP <2042> Disintegration and Dissolution of Buccal Tablets testing can result in:

  • Product recalls and reputational damage

  • Non-compliance with regulations and standards

  • Reduced product effectiveness and bioavailability

  • Loss of customer confidence and trust

    • Industries and Sectors that Require This Testing

    The following industries and sectors require USP <2042> Disintegration and Dissolution of Buccal Tablets testing:

  • Pharmaceutical manufacturing

  • Biotechnology

  • Medical device development

  • Cosmetics and personal care products

    • Risk Factors and Safety Implications

    USP <2042> Disintegration and Dissolution of Buccal Tablets testing assesses the risk factors associated with buccal tablets, including:

  • Bioavailability and efficacy

  • Product safety and quality

  • Regulatory compliance

  • Customer confidence and trust

    • Quality Assurance and Quality Control Aspects

    Eurolab ensures that all USP <2042> Disintegration and Dissolution of Buccal Tablets testing is conducted in accordance with established quality assurance and quality control measures, including:

  • Use of approved test equipment and instruments

  • Following specified testing procedures and protocols

  • Maintaining accurate records and documentation

    • Test Equipment and Instruments

    Eurolab uses the following test equipment and instruments for USP <2042> Disintegration and Dissolution of Buccal Tablets testing:

  • Automated disintegration testers (e.g., Distek)

  • Dissolution apparatuses (e.g., Hanson Research)

  • pH meters and conductivity meters

    • Testing Procedures and Protocols

    Eurolab follows the following testing procedures and protocols for USP <2042> Disintegration and Dissolution of Buccal Tablets testing:

  • Sample preparation

  • Disintegration and dissolution testing

  • Data analysis and interpretation

    • Records and Documentation

    Eurolab maintains accurate records and documentation for all USP <2042> Disintegration and Dissolution of Buccal Tablets testing, including:

  • Test results and data

  • Quality control measures

  • Calibration and maintenance records

    • Test Methods and Procedures

    Eurolab uses the following test methods and procedures for USP <2042> Disintegration and Dissolution of Buccal Tablets testing:

  • Automated disintegration testers (e.g., Distek)

  • Dissolution apparatuses (e.g., Hanson Research)

  • pH meters and conductivity meters

    • Instrument Calibration and Maintenance

    Eurolab ensures that all test equipment and instruments used for USP <2042> Disintegration and Dissolution of Buccal Tablets testing are calibrated and maintained according to the manufacturers specifications.

    Sampling and Sample Preparation

    Eurolab follows established sampling and sample preparation procedures for USP <2042> Disintegration and Dissolution of Buccal Tablets testing, including:

  • Selecting representative samples

  • Preparing samples for disintegration and dissolution testing

    • Quality Control Measures

    Eurolab implements quality control measures to ensure the accuracy and reliability of USP <2042> Disintegration and Dissolution of Buccal Tablets testing results, including:

  • Use of approved test equipment and instruments

  • Following specified testing procedures and protocols

  • Maintaining accurate records and documentation

    • Test Results and Data

    Eurolab provides detailed test results and data for all USP <2042> Disintegration and Dissolution of Buccal Tablets testing, including:

  • Disintegration and dissolution times

  • pH and conductivity measurements

  • Bioavailability and efficacy assessments

    • Interpretation and Reporting

    Eurolab interprets and reports test results in accordance with established standards and guidelines, including:

  • USP <2042> Disintegration and Dissolution of Buccal Tablets testing

  • ISO 11607: Packaging for terminally sterilized medical devices

  • ASTM F2423: Standard guide for selection of materials for controlled release dosage forms

    • Customer Confidence and Trust

    Eurolab ensures that all USP <2042> Disintegration and Dissolution of Buccal Tablets testing is conducted with the utmost care and attention to detail, resulting in:

  • Enhanced customer confidence and trust

  • Improved product quality and efficacy

  • Compliance with regulatory requirements and standards

    • Regulatory Compliance

    Eurolab ensures that all USP <2042> Disintegration and Dissolution of Buccal Tablets testing is conducted in accordance with established regulations and standards, including:

  • USP <2042> Disintegration and Dissolution of Buccal Tablets testing

  • ISO 11607: Packaging for terminally sterilized medical devices

  • ASTM F2423: Standard guide for selection of materials for controlled release dosage forms

    • Standard Evolution and Updates

    Eurolab stays up-to-date with the latest developments and updates in USP <2042> Disintegration and Dissolution of Buccal Tablets testing, including:

  • New technologies and methodologies

  • Emerging industry needs and requirements

  • Regulatory changes and updates

    • Eurolab uses a range of test equipment and instruments for USP <2042> Disintegration and Dissolution of Buccal Tablets testing, including:

  • Automated disintegration testers (e.g., Distek)

  • Dissolution apparatuses (e.g., Hanson Research)

  • pH meters and conductivity meters

    • Eurolab follows established testing procedures and protocols for USP <2042> Disintegration and Dissolution of Buccal Tablets testing, including:

  • Sample preparation

  • Disintegration and dissolution testing

  • Data analysis and interpretation

    • Eurolab maintains accurate records and documentation for all USP <2042> Disintegration and Dissolution of Buccal Tablets testing, including:

  • Test results and data

  • Quality control measures

  • Calibration and maintenance records

    • Biological Testing

    Eurolab offers biological testing services for USP <2042> Disintegration and Dissolution of Buccal Tablets testing, including:

  • In vitro dissolution testing

  • In vivo absorption testing

  • Bioavailability and efficacy assessments

    • Physical Testing

    Eurolab offers physical testing services for USP <2042> Disintegration and Dissolution of Buccal Tablets testing, including:

  • Moisture content analysis

  • Density measurements

  • Hardness testing

    • Chemical Testing

    Eurolab offers chemical testing services for USP <2042> Disintegration and Dissolution of Buccal Tablets testing, including:

  • pH and conductivity measurements

  • Elemental analysis (e.g., ICP-MS)

  • Moisture content analysis

    • Eurolab uses a range of test methods and procedures for USP <2042> Disintegration and Dissolution of Buccal Tablets testing, including:

  • Automated disintegration testers (e.g., Distek)

  • Dissolution apparatuses (e.g., Hanson Research)

  • pH meters and conductivity meters

    • Eurolab ensures that all test equipment and instruments used for USP <2042> Disintegration and Dissolution of Buccal Tablets testing are calibrated and maintained according to the manufacturers specifications.

    Eurolab follows established sampling and sample preparation procedures for USP <2042> Disintegration and Dissolution of Buccal Tablets testing, including:

  • Selecting representative samples

  • Preparing samples for disintegration and dissolution testing

    • Eurolab implements quality control measures to ensure the accuracy and reliability of USP <2042> Disintegration and Dissolution of Buccal Tablets testing results, including:

  • Use of approved test equipment and instruments

  • Following specified testing procedures and protocols

  • Maintaining accurate records and documentation

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

    CONTACT US +902127020000

    Latest News

    View all

    Eurolab Successfully Renews ISO 17025 Accreditation

    Read More

    Expanded Cosmetic Safety Testing Portfolio Now Available at Eurolab

    Read More

    Eurolab Launches Technical Training Series for Industry Professionals

    Read More

    JOIN US
    Want to make a difference?

    Careers