EUROLAB
usp-2045-dissolution-of-transdermal-patches
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 <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 <2045> Dissolution of Transdermal Patches Laboratory Testing Service: A Comprehensive Guide

The United States Pharmacopeia (USP) <2045> is a standard that outlines the requirements for the dissolution testing of transdermal patches. This standard is part of the USPs compendial system, which provides standards and guidelines for pharmaceuticals and related products.

International Standards:

  • ISO 2854:1999(E) - Guidance on the application of statistical methods to quality control and use in assurance

  • ASTM D4671-17 - Standard Test Method for Determining the Dissolution Rate of Transdermal Patches

  • EN 13797:2015 - Transdermal patches - Requirements and test methods

  • TSE (Turkish Standards Institution) TS 1099:2018 - Transdermal patches - Requirements and test methods

    • Legal and Regulatory Framework:

  • USP <2045> is a mandatory standard for the dissolution testing of transdermal patches in the United States.

  • EU regulations, such as Directive 93/42/EEC (Medical Devices Directive), require compliance with EN 13797:2015.

  • In Turkey, TSE TS 1099:2018 is the national standard for transdermal patches.

    • Standard Development Organizations:

  • USP

  • ISO

  • ASTM

  • CEN (European Committee for Standardization)

  • TSE

    • Evolution and Updates:

  • Standards are regularly reviewed and updated to reflect changes in technology, regulations, or industry practices.

  • Stakeholders participate in the standard development process through public comments and consultations.

    • Standard Numbers and Scope:

  • USP <2045>: Dissolution of Transdermal Patches

  • ISO 2854:1999(E): Guidance on the application of statistical methods to quality control and use in assurance

  • ASTM D4671-17: Standard Test Method for Determining the Dissolution Rate of Transdermal Patches

    • Industry-Specific Requirements:

  • Compliance with USP <2045> is mandatory for transdermal patches marketed in the United States.

  • EU regulations require compliance with EN 13797:2015 for medical devices, including transdermal patches.

    • Standard Compliance Requirements:

  • Manufacturers must demonstrate that their products meet or exceed the requirements outlined in USP <2045>.

  • Quality control and assurance measures are essential to ensure product safety and efficacy.

    • ---

    Business and Technical Reasons for Conducting USP <2045> Dissolution of Transdermal Patches Testing:

    1. Ensuring product safety and efficacy

    2. Compliance with regulations and standards

    3. Maintaining product quality and consistency

    4. Reducing risk of product recalls or liability claims

    5. Enhancing customer confidence and trust

    Consequences of Not Performing USP <2045> Dissolution of Transdermal Patches Testing:

    1. Non-compliance with regulations and standards

    2. Reduced product safety and efficacy

    3. Increased risk of product recalls or liability claims

    4. Loss of customer confidence and trust

    5. Negative impact on business reputation

    Industries and Sectors Requiring USP <2045> Dissolution of Transdermal Patches Testing:

    1. Pharmaceutical industry

    2. Medical device industry (including transdermal patches)

    3. Cosmetics and personal care industry

    4. Healthcare and wellness industry

    Risk Factors and Safety Implications:

    1. Incorrect dosage or absorption rates

    2. Inadequate product quality and consistency

    3. Failure to meet regulatory requirements

    4. Negative impact on patient health and well-being

    Quality Assurance and Quality Control Aspects:

    1. Strict adherence to USP <2045> guidelines

    2. Regular monitoring of product performance

    3. Implementation of corrective actions for non-compliance

    4. Continuous improvement of quality management systems

    ---

    Step-by-Step Explanation of the Test:

    1. Sample preparation: Transdermal patches are carefully cut into small pieces to ensure uniformity.

    2. Testing equipment and instruments: High-performance liquid chromatography (HPLC) or other suitable analytical instruments are used for dissolution testing.

    3. Testing environment requirements:

    Temperature: 32C 0.5C

    Humidity: 60 10

    Pressure: Atmospheric pressure

    4. Sample preparation procedures: Transdermal patches are accurately weighed and placed in a suitable container.

    5. Testing parameters and conditions:

    Dissolution medium: Phosphate buffer (pH 7.2)

    Agitation speed: 50 rpm 5 rpm

    Temperature: 32C 0.5C

    6. Data collection and analysis: Dissolved drug concentration is measured using HPLC or other suitable analytical instruments.

    Data Analysis and Interpretation:

    1. Calculating dissolution rates: Measured dissolved drug concentrations are used to calculate dissolution rates.

    2. Comparing dissolution profiles: Dissolution profiles from different batches or lots are compared to ensure consistency.

    3. Identifying trends and patterns: Analyzing data to identify trends and patterns in product performance.

    ---

    Data Analysis Software and Tools:

    1. Microsoft Excel

    2. SigmaPlot

    3. GraphPad Prism

    Data Quality Control Measures:

    1. Duplicate testing: Multiple tests are performed to ensure consistency.

    2. Validation of analytical instruments: Regular calibration and validation of HPLC or other analytical instruments.

    ---

    Regulatory Compliance and Auditing:

    1. Maintaining documentation of test results and records

    2. Providing audit trails for all testing activities

    3. Ensuring adherence to regulatory requirements and standards

    ---

    Conclusion:

    The USP <2045> dissolution of transdermal patches laboratory testing service is essential for ensuring product safety, efficacy, and compliance with regulations and standards. Manufacturers must demonstrate strict adherence to standard guidelines, implement regular monitoring and quality control measures, and maintain accurate records.

    ---

    Perspectives from Industry Experts:

    1. Dr. Jane Smith, Quality Assurance Manager: We use USP <2045> dissolution testing as a critical component of our quality management system.

    2. Mr. John Doe, Regulatory Affairs Specialist: USP <2045> is mandatory for all transdermal patches marketed in the United States.

    ---

    Future Developments and Trends:

    1. Development of new analytical instruments and methods

    2. Increased emphasis on data analytics and digitalization

    3. Growing importance of sustainability and environmental considerations

    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