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usp-1091-assessment-of-drug-release-from-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 <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 <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 <1091> Assessment of Drug Release from Microspheres Laboratory Testing Service

Provided by Eurolab: A Complete Guide to Quality Assurance and Compliance

The USP <1091> Assessment of Drug Release from Microspheres is a critical laboratory test that evaluates the release profile of drug substances from microsphere formulations. This standard is governed by the United States Pharmacopeia (USP), an independent, non-profit organization that sets standards for the quality and purity of pharmaceutical ingredients.

Legal and Regulatory Framework

The USP <1091> Assessment of Drug Release from Microspheres testing is mandated by regulatory agencies worldwide, including the US Food and Drug Administration (FDA). Compliance with this standard is essential to ensure product safety and efficacy. Failure to comply can result in regulatory action, product recalls, and financial losses.

International and National Standards

The following international and national standards apply to this specific laboratory test:

  • USP <1091> Assessment of Drug Release from Microspheres

  • ISO 10993-12:2012 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials

  • ASTM E2111-14 Standard Practice for Determining the In Vitro Release Rate of Pharmaceuticals from Microsphere Formulations

    • Standard Development Organizations

    The USP, ISO, and ASTM are leading standard development organizations that set standards for laboratory testing. These organizations collaborate to ensure consistency and alignment across industries.

    Standard Evolution and Updates

    Standards evolve over time as new technologies and regulations emerge. Regular updates ensure that standards remain relevant and effective in ensuring product safety and quality.

    Industry-Specific Standard Numbers and Scope

    The following standard numbers and scope are specific to this laboratory test:

  • USP <1091>: Assessment of Drug Release from Microspheres

    • Scope: Evaluates the release profile of drug substances from microsphere formulations.

    Applies to: Pharmaceutical companies, research institutions, and regulatory agencies.

    Standard Compliance Requirements

    Compliance with this standard is mandatory for industries that produce or distribute pharmaceutical products. Failure to comply can result in regulatory action, product recalls, and financial losses.

    The following table summarizes the key aspects of USP <1091> Assessment of Drug Release from Microspheres testing:

    Aspect Description

    --- ---

    Scope Evaluates the release profile of drug substances from microsphere formulations.

    Regulatory Requirements Mandated by regulatory agencies worldwide, including the US FDA.

    International and National Standards USP <1091>, ISO 10993-12:2012, ASTM E2111-14.

    Standard Development Organizations USP, ISO, ASTM.

    The USP <1091> Assessment of Drug Release from Microspheres testing is essential for ensuring product safety and efficacy. The following reasons explain why this test is required:

  • Business and Technical Reasons: Pharmaceutical companies must ensure that their products meet regulatory requirements to maintain market access and avoid financial losses.

  • Consequences of Not Performing the Test: Failure to comply with USP <1091> can result in regulatory action, product recalls, and financial losses.

  • Industries and Sectors Requiring This Testing: Pharmaceutical companies, research institutions, and regulatory agencies require this testing for product safety and quality assurance.

    • The following table summarizes the key aspects of USP <1091> Assessment of Drug Release from Microspheres testing:

    Aspect Description

    --- ---

    Industry-Specific Needs Pharmaceutical companies, research institutions, and regulatory agencies require this testing for product safety and quality assurance.

    Risk Factors and Safety Implications Failure to comply with USP <1091> can result in regulatory action, product recalls, and financial losses.

    The following step-by-step explanation outlines the test conditions and methodology for USP <1091> Assessment of Drug Release from Microspheres testing:

    1. Sample Preparation: Collect and prepare microsphere samples according to established protocols.

    2. Testing Equipment and Instruments: Use specialized equipment, such as dissolution apparatus and spectrophotometers.

    3. Testing Environment Requirements: Maintain a controlled environment with specified temperature, humidity, and pressure conditions.

    4. Measurement and Analysis Methods: Measure and analyze the release profile of drug substances using spectroscopic techniques.

    The following table summarizes the key aspects of USP <1091> Assessment of Drug Release from Microspheres testing:

    Aspect Description

    --- ---

    Sample Preparation Collect and prepare microsphere samples according to established protocols.

    Testing Equipment and Instruments Use specialized equipment, such as dissolution apparatus and spectrophotometers.

    The following figure illustrates the test conditions and methodology for USP <1091> Assessment of Drug Release from Microspheres testing:

    Insert Figure: Test Conditions and Methodology

    This guide has provided a comprehensive overview of the USP <1091> Assessment of Drug Release from Microspheres laboratory testing service, including standard-related information, standard requirements and needs, and test conditions and methodology. By understanding this critical laboratory test, pharmaceutical companies can ensure product safety and quality assurance, while regulatory agencies can verify compliance with regulatory requirements.

    Conclusion

    The USP <1091> Assessment of Drug Release from Microspheres testing is a critical laboratory test that evaluates the release profile of drug substances from microsphere formulations. Compliance with this standard is essential to ensure product safety and efficacy. By understanding the standard-related information, standard requirements and needs, and test conditions and methodology, pharmaceutical companies can ensure compliance and maintain market access.

    References

    1. United States Pharmacopeia (USP). USP <1091> Assessment of Drug Release from Microspheres.

    2. International Organization for Standardization (ISO). ISO 10993-12:2012 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials.

    3. American Society for Testing and Materials (ASTM). ASTM E2111-14 Standard Practice for Determining the In Vitro Release Rate of Pharmaceuticals from Microsphere Formulations.

    This guide has provided a comprehensive overview of the USP <1091> Assessment of Drug Release from Microspheres laboratory testing service. By understanding this critical laboratory test, pharmaceutical companies can ensure product safety and quality assurance, while regulatory agencies can verify compliance with regulatory requirements.

    Appendix

    The following appendix provides additional information on related topics:

  • Glossary: Defines key terms used in the guide.

  • Regulatory Framework: Provides an overview of relevant regulations and guidelines.

  • Industry-Specific Requirements: Summarizes industry-specific needs and standards.

    • By providing a comprehensive resource for USP <1091> Assessment of Drug Release from Microspheres testing, this guide aims to support pharmaceutical companies and regulatory agencies in ensuring product safety and quality assurance.

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