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usp-2049-disintegration-of-drug-eluting-stents
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 <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 <2049> Disintegration of Drug-Eluting Stents Laboratory Testing Service: A Comprehensive Guide

The USP <2049> Disintegration of Drug-Eluting Stents testing service is governed by a set of international and national standards that ensure the safety, efficacy, and quality of drug-eluting stents. The primary standards applicable to this test are:

  • ISO 7198:2017 - Cardiovascular implants - Endovascular devices - Particular requirements for vascular stents

  • ASTM F2840-17 - Standard Practice for Testing Stent Crimping Characteristics

  • EN 1503:2020 - Cardiovascular implants - General requirements

  • TSE (Turkish Standards Institution) TS ISO 7198

    • These standards outline the requirements for testing, calibration, and validation of stents to ensure they meet the necessary performance, safety, and efficacy criteria. The standard development organizations responsible for these standards are:

  • International Organization for Standardization (ISO)

  • American Society for Testing and Materials (ASTM)

  • European Committee for Standardization (CEN)

    • Standards evolve over time due to advancements in technology, changing regulatory requirements, or industry feedback. Manufacturers must stay up-to-date with the latest revisions to ensure compliance.

    The USP <2049> Disintegration of Drug-Eluting Stents testing service is crucial for ensuring the quality and safety of stents. The primary reasons for conducting this test are:

  • To assess the disintegration characteristics of drug-eluting stents

  • To evaluate the performance, safety, and efficacy of stents under simulated physiological conditions

  • To ensure compliance with regulatory requirements and industry standards

    • Consequences of not performing this test include:

  • Non-compliance with regulatory requirements, potentially leading to product recalls or market withdrawal

  • Risk of stent failure or adverse events in patients

  • Damage to a companys reputation and brand image

    • Industries requiring this testing service include:

  • Medical device manufacturers (stent producers)

  • Regulatory bodies and government agencies

  • Quality assurance and quality control organizations

    • Risk factors and safety implications associated with non-compliance include:

  • Patient harm or injury due to stent failure or adverse events

  • Financial losses due to product recalls, litigation, or regulatory actions

  • Damage to a companys reputation and brand image

    • The USP <2049> Disintegration of Drug-Eluting Stents testing service involves the following steps:

    1. Sample Preparation: Stent samples are prepared according to the manufacturers instructions.

    2. Testing Equipment and Instruments: The test is conducted using a disintegration device, which simulates physiological conditions (e.g., temperature, pH).

    3. Testing Environment Requirements: The testing environment must meet specific requirements for temperature, humidity, and pressure.

    4. Measurement and Analysis Methods: Disintegration characteristics are measured and analyzed using specialized instruments (e.g., optical microscopy).

    The test report includes:

  • A summary of the testing conditions

  • Results of disintegration analysis

  • Any deviations from standard procedures or requirements

  • Recommendations for further testing or improvements

    • Eurolabs state-of-the-art equipment, qualified personnel, and accreditation ensure high-quality results. Our electronic reporting system provides fast and secure access to test reports.

    Performing the USP <2049> Disintegration of Drug-Eluting Stents testing service offers numerous benefits:

  • Risk Assessment and Mitigation: Testing ensures compliance with regulatory requirements, reducing the risk of product recalls or market withdrawal.

  • Quality Assurance and Compliance: Regular testing helps maintain a high level of quality, ensuring products meet industry standards and regulations.

  • Competitive Advantages: Companies that prioritize quality and safety demonstrate their commitment to excellence, enhancing their reputation and brand image.

  • Cost Savings: Identifying potential issues early on can prevent costly recalls or litigation.

    • Eurolabs expertise in the field of stent testing ensures high-quality results. Our:

  • State-of-the-art equipment

  • Qualified and certified personnel

  • Accreditation and certification details

  • International recognition and partnerships

  • Quality management systems and procedures

  • Customer service and support capabilities

    • make us an ideal partner for your USP <2049> Disintegration of Drug-Eluting Stents testing needs.

    Conclusion

    The USP <2049> Disintegration of Drug-Eluting Stents testing service is a critical aspect of ensuring the quality, safety, and efficacy of stents. Eurolabs expertise, state-of-the-art equipment, and commitment to quality make us an ideal partner for your testing needs. By choosing our services, you can ensure compliance with regulatory requirements, reduce the risk of product recalls or market withdrawal, and maintain a high level of quality and safety in your products.

    References

    1. USP <2049> - Disintegration of Drug-Eluting Stents

    2. ISO 7198:2017 - Cardiovascular implants - Endovascular devices - Particular requirements for vascular stents

    3. ASTM F2840-17 - Standard Practice for Testing Stent Crimping Characteristics

    4. EN 1503:2020 - Cardiovascular implants - General requirements

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