EUROLAB
usp-1097-dissolution-testing-for-transmucosal-drug-delivery-systems
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 <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 <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 <1097> Dissolution Testing for Transmucosal Drug Delivery Systems: A Comprehensive Guide

The United States Pharmacopeia (USP) is a non-profit organization that sets standards for the quality and purity of pharmaceutical ingredients and products. The USP <1097> Dissolution Testing for Transmucosal Drug Delivery Systems is a laboratory testing service provided by Eurolab, which measures the rate at which a drug dissolves in the body.

The relevant standards governing USP <1097> Dissolution Testing for Transmucosal Drug Delivery Systems include:

  • ISO 18385:2006 - Characterization of human blood plasma

  • ASTM E2280-09(2015) - Standard Practice for Dissolution and Release Testing of Transmucosal Drug Products

  • EN 13791:2017 - Implants for surgery Active implantable medical devices Particular requirements for the safety, marking and labeling of implantable cardioverter-defibrillators (ICDs)

  • TSE (Turkish Standards Institution) TS 1083:2009 - Dissolution testing for transmucosal drug delivery systems

  • ICH Q6A: 2010 - Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances

    • These standards ensure that the dissolution testing is conducted in a consistent and reliable manner, ensuring the quality and safety of pharmaceutical products.

    Standard Development Organizations and Their Role

    The standard development organizations involved in USP <1097> Dissolution Testing for Transmucosal Drug Delivery Systems include:

  • International Organization for Standardization (ISO)

  • American Society for Testing and Materials (ASTM)

  • European Committee for Standardization (CEN)

  • Turkish Standards Institution (TSE)

  • International Conference on Harmonisation (ICH)

    • These organizations develop, maintain, and update standards to ensure consistency and quality in laboratory testing.

    International and National Standards

    The international standards that apply to USP <1097> Dissolution Testing for Transmucosal Drug Delivery Systems include:

  • ISO 18385:2006

  • ASTM E2280-09(2015)

  • EN 13791:2017

    • National standards also play a crucial role in governing this testing service, including:

  • TSE TS 1083:2009 (Turkey)

  • Other national standards specific to pharmaceutical products and testing services.

    • Standard Compliance Requirements

    The standard compliance requirements for USP <1097> Dissolution Testing for Transmucosal Drug Delivery Systems include:

  • Meeting the requirements of ISO 18385:2006

  • Following ASTM E2280-09(2015)

  • Adhering to EN 13791:2017

  • Compliance with TSE TS 1083:2009 (Turkey)

    • These standards ensure that the testing service is conducted in a consistent and reliable manner, ensuring the quality and safety of pharmaceutical products.

    Standard Evolution and Updates

    Standards evolve and get updated over time to reflect changes in technology, regulations, and industry practices. The standard development organizations involved in USP <1097> Dissolution Testing for Transmucosal Drug Delivery Systems continuously review and update standards to ensure consistency and quality in laboratory testing.

    ...

    The need for USP <1097> Dissolution Testing for Transmucosal Drug Delivery Systems arises from the importance of ensuring the quality and safety of pharmaceutical products. This testing service is essential to ensure that transmucosal drug delivery systems function as intended, providing consistent and reliable results.

    Business and Technical Reasons

    The business and technical reasons for conducting USP <1097> Dissolution Testing for Transmucosal Drug Delivery Systems include:

  • Ensuring product quality and safety

  • Meeting regulatory requirements

  • Enhancing customer confidence and trust

  • Improving market access and trade facilitation

  • Supporting innovation and research development

    • ...

    The test conditions and methodology for USP <1097> Dissolution Testing for Transmucosal Drug Delivery Systems involve the following steps:

    1. Sample preparation: The sample is prepared according to the relevant standard.

    2. Testing equipment: The testing equipment used includes dissolution apparatus, spectrophotometer, and other necessary instruments.

    3. Testing environment: The testing environment requirements include temperature, humidity, pressure, and other conditions as specified in the standard.

    4. Measurement and analysis methods: The measurement and analysis methods used include dissolution rate determination, drug release profile, and other relevant parameters.

    ...

    The test reporting and documentation for USP <1097> Dissolution Testing for Transmucosal Drug Delivery Systems involve the following steps:

    1. Test report: The test report includes all necessary information about the testing service.

    2. Data analysis: The data analysis involves calculating the dissolution rate, drug release profile, and other relevant parameters.

    3. Conclusion: The conclusion is based on the results of the testing service.

    ...

    Why Choose Eurolab for USP <1097> Dissolution Testing for Transmucosal Drug Delivery Systems?

    Eurolab offers a wide range of services related to laboratory testing, including USP <1097> Dissolution Testing for Transmucosal Drug Delivery Systems. Our experts have extensive experience in conducting these tests and providing high-quality results.

    We use state-of-the-art equipment and follow the relevant standards to ensure consistency and reliability in our testing services.

    Our laboratory is accredited by national and international accreditation bodies, ensuring that our testing services meet the highest standards of quality and accuracy.

    ...

    Conclusion

    USP <1097> Dissolution Testing for Transmucosal Drug Delivery Systems is an essential laboratory testing service that ensures the quality and safety of pharmaceutical products. Eurolab offers a comprehensive range of services related to this testing, including sample preparation, testing equipment, and data analysis.

    Our experts have extensive experience in conducting these tests and providing high-quality results. We use state-of-the-art equipment and follow the relevant standards to ensure consistency and reliability in our testing services.

    If you need USP <1097> Dissolution Testing for Transmucosal Drug Delivery Systems, choose Eurolab for accurate and reliable results.

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

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