EUROLAB
usp-2060-in-vitro-release-of-drug-from-polymeric-microspheres
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 <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 <2060> In Vitro Release of Drug from Polymeric Microspheres Laboratory Testing Service Provided by Eurolab

The USP <2060> In Vitro Release of Drug from Polymeric Microspheres testing service provided by Eurolab is governed by a range of international and national standards. These standards ensure that the testing is conducted in accordance with established protocols and procedures.

International Standards

  • ISO 10993-1:2009 - Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process

  • ISO 14644-1:2015 - Cleanrooms and associated controlled environments -- Part 1: Classification of air cleanliness

  • ASTM E1383-08 - Standard Guide for Determining the In Vitro Release of Biologically Active Agents from Polymeric Devices

    • National Standards

  • EU GMP Annex 1 - Manufacture of Sterile Medicinal Products

  • US FDA Guidance for Industry: Bioanalytical Method Validation

  • Japanese Pharmacopoeia (JP) - Section 11.02: Biological tests for pharmaceuticals

    • Standard Development Organizations and their Role

  • International Organization for Standardization (ISO)

  • American Society for Testing and Materials (ASTM)

  • European Committee for Standardization (CEN)

    • Evolution of Standards

    Standards evolve through a continuous process of review, revision, and update. This ensures that the standards remain relevant and effective in meeting the needs of industry and regulatory requirements.

    Standard Numbers and Scope

  • ISO 10993-1:2009 - Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process

    • Scope: Evaluation and testing of biological properties of medical devices

  • ASTM E1383-08 - Standard Guide for Determining the In Vitro Release of Biologically Active Agents from Polymeric Devices

    • Scope: Guidance for determining the in vitro release of biologically active agents from polymeric devices

    Standard Compliance Requirements

    Compliance with standards is mandatory for industries such as pharmaceuticals, medical devices, and cosmetics.

  • EU GMP Annex 1 - Manufacture of Sterile Medicinal Products

    • Requires compliance with cleanroom standards (ISO 14644-1:2015)

  • US FDA Guidance for Industry: Bioanalytical Method Validation

    • Requires validation of bioanalytical methods in accordance with ISO 11133:2009

    Standard-Related Risks and Consequences

    Non-compliance with standards can result in significant risks, including:

  • Product failure or contamination

  • Regulatory non-compliance

  • Reputation damage and financial losses

  • Inability to access international markets

    • The USP <2060> In Vitro Release of Drug from Polymeric Microspheres testing service is required for the following reasons:

  • Product Safety: Ensures that products meet safety requirements by demonstrating controlled release of active agents.

  • Regulatory Compliance: Complies with regulatory requirements, such as EU GMP Annex 1 and US FDA Guidance for Industry: Bioanalytical Method Validation.

  • Quality Assurance: Validates product quality through testing, ensuring that products meet specified performance criteria.

  • Cost Savings: Identifies potential issues early in the development process, reducing costs associated with rework or recalls.

    • Business and Technical Reasons

    Conducting USP <2060> In Vitro Release of Drug from Polymeric Microspheres testing provides businesses with a competitive advantage by:

  • Demonstrating compliance with regulatory requirements

  • Ensuring product safety and efficacy

  • Validating quality through testing

    • Industries and Sectors Requiring This Testing

    The following industries and sectors require USP <2060> In Vitro Release of Drug from Polymeric Microspheres testing:

  • Pharmaceuticals

  • Medical devices

  • Cosmetics

  • Biotechnology

    • The USP <2060> In Vitro Release of Drug from Polymeric Microspheres testing service involves the following steps:

    1. Sample Preparation: Preparing the test samples in accordance with standard procedures.

    2. Equipment Calibration: Calibrating equipment to ensure accuracy and precision.

    3. Testing Parameters: Setting testing parameters, such as temperature, pH, and agitation speed.

    4. Measurement and Analysis: Measuring and analyzing release profiles using techniques such as HPLC or LC-MS.

    5. Data Collection and Recording: Collecting and recording data in accordance with standard protocols.

    The test report includes the following information:

  • Introduction: Brief overview of the testing service

  • Materials and Methods: Description of materials, methods, and equipment used

  • Results: Release profiles obtained from testing

  • Discussion: Interpretation of results in relation to product performance

  • Conclusion: Summary of findings and recommendations

    • Test Report Format

    The test report is formatted according to standard guidelines, such as ASTM E1383-08.

    Persuasive Writing Example

    The USP <2060> In Vitro Release of Drug from Polymeric Microspheres testing service provided by Eurolab ensures that your products meet regulatory requirements and demonstrate controlled release of active agents. Our experienced team conducts thorough testing using validated methods, providing you with accurate results and a competitive advantage in the market.

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

    CONTACT US +902127020000

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