EUROLAB
usp-2080-drug-release-from-drug-eluting-coils
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 <2078> Dissolution of Floating TabletsUSP <2079> Disintegration Test for Multi-Unit Pellet SystemsUSP <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

Comprehensive Guide to USP <2080> Drug Release from Drug-Eluting Coils Laboratory Testing Service

Standard-Related Information

USP <2080> is a United States Pharmacopeia (USP) standard that governs the testing of drug release from drug-eluting coils. The standard provides guidelines for laboratory testing to ensure that these medical devices meet specific requirements for controlled release of therapeutic agents.

The relevant standards that apply to this testing service include:

  • ISO 10993-5:2015 (Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity)

  • ASTM F2844-13 (Standard Test Method for In Vitro Release Testing of Therapeutic and/or Diagnostic Agents from Drug Eluting Coils)

    • The legal and regulatory framework surrounding this testing service is governed by the USP, which sets forth the requirements for laboratory testing to ensure compliance with established standards.

    Standard Requirements and Needs

    USP <2080> Drug Release from Drug-Eluting Coils testing is required to ensure that medical devices meet specific requirements for controlled release of therapeutic agents. The business and technical reasons for conducting this test include:

  • Ensuring the safety and efficacy of drug-eluting coils

  • Verifying compliance with established standards

  • Providing quality assurance and quality control measures

  • Supporting regulatory compliance and international market access

    • The consequences of not performing this test include:

  • Non-compliance with regulatory requirements

  • Potential harm to patients and users of medical devices

  • Damage to reputation and loss of customer trust

    • The industries and sectors that require this testing include:

  • Medical device manufacturers

  • Pharmaceutical companies

  • Regulatory agencies and government institutions

    • Test Conditions and Methodology

    USP <2080> Drug Release from Drug-Eluting Coils testing involves the following steps:

    1. Sample preparation: The drug-eluting coil is prepared for testing by cleaning, drying, and cutting into sections.

    2. Testing equipment and instruments: The test is conducted using specialized equipment, such as a dissolution apparatus, to simulate physiological conditions.

    3. Testing environment requirements: The testing environment must meet specific temperature, humidity, and pressure requirements to accurately simulate physiological conditions.

    4. Measurement and analysis methods: The release of therapeutic agents from the drug-eluting coil is measured using techniques such as high-performance liquid chromatography (HPLC) or mass spectrometry.

    The calibration and validation procedures involve:

  • Ensuring that all equipment and instruments are calibrated and validated according to established standards

  • Verifying that the testing environment meets specific requirements

    • Test Reporting and Documentation

    The test results are documented and reported in a standardized format, including:

  • A detailed description of the testing procedure

  • Results of measurements and analyses

  • Interpretation of results

  • Certification and accreditation information

    • The report must comply with established standards for documentation and reporting.

    Why This Test Should Be Performed

    Performing USP <2080> Drug Release from Drug-Eluting Coils testing provides numerous benefits, including:

  • Ensuring compliance with regulatory requirements

  • Verifying the safety and efficacy of medical devices

  • Supporting quality assurance and quality control measures

  • Enhancing customer confidence and trust

  • Facilitating international market access

    • Why Eurolab Should Provide This Service

    Eurolab is an expert in providing USP <2080> Drug Release from Drug-Eluting Coils testing services, with:

  • State-of-the-art equipment and facilities

  • Qualified and certified personnel

  • Accreditation and certification details

  • International recognition and partnerships

    • Eurolabs quality management systems and procedures ensure:

  • Efficient turnaround times

  • Competitive pricing and value proposition

  • Technical support and consultation services

    • Customer Testimonials

    I was impressed with Eurolabs expertise in providing USP <2080> Drug Release from Drug-Eluting Coils testing. Their report was comprehensive and easy to understand. - Client Name

    The turnaround time for our testing was impressive, and we appreciated the technical support provided by Eurolab. - Client Name

    We have been working with Eurolab for years, and their quality management systems and procedures are among the best in the industry. - Client Name

    Additional Information

    Eurolab is committed to providing accurate and reliable testing services. Our team of experts will guide you through every step of the process.

    We understand that every client has unique needs, and we offer customized solutions to meet your specific requirements.

    Contact us today to learn more about our USP <2080> Drug Release from Drug-Eluting Coils testing services.

    Conclusion

    USP <2080> Drug Release from Drug-Eluting Coils testing is a critical component of ensuring the safety and efficacy of medical devices. Eurolabs expertise, state-of-the-art equipment, and quality management systems make us the ideal partner for this testing service.

    Dont hesitate to contact us today to learn more about our USP <2080> Drug Release from Drug-Eluting Coils testing services.

    References

  • ISO 10993-5:2015 (Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity)

  • ASTM F2844-13 (Standard Test Method for In Vitro Release Testing of Therapeutic and/or Diagnostic Agents from Drug Eluting Coils)

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