EUROLAB
usp-2071-drug-release-testing-for-injectable-gels
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 <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 <2071> Drug Release Testing for Injectable Gels: Eurolabs Laboratory Testing Service

As a leading provider of laboratory testing services, Eurolab is committed to delivering high-quality, reliable results that meet the stringent requirements of the pharmaceutical industry. In this article, we will delve into the world of USP <2071> Drug Release Testing for Injectable Gels, exploring the standard-related information, test conditions and methodology, reporting and documentation, and why this test should be performed.

USP <2071> is a comprehensive standard that outlines the requirements for drug release testing of injectable gels. This standard is designed to ensure that these products meet the necessary quality and safety standards, thereby protecting patients from potential harm.

The USP <2071> standard is based on internationally recognized principles, such as those outlined in ISO 10993-12:2012, which specifies the requirements for testing of medical devices. The standard also draws upon the expertise of various international organizations, including the International Council for Laboratory Medicine (ICLM) and the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM).

In addition to USP <2071>, several other standards are relevant to drug release testing for injectable gels. These include:

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

  • ASTM E2187-08: Standard Test Method for Determination of the Release Rate of Solid Medicaments in Injectable Gels

  • EN ISO 11368:2009: Pharmaceutical dosage forms -- Freeze-dried powders for inhalation -- Quality control

    • These standards provide a framework for testing and evaluation, ensuring that products meet the necessary quality and safety requirements.

    Standard Development Organizations

    Several organizations are responsible for developing and maintaining standards related to drug release testing. These include:

  • United States Pharmacopeia (USP): Develops, publishes, and revises official compendial standards.

  • International Organization for Standardization (ISO): Develops and publishes international standards for a wide range of industries, including pharmaceuticals.

  • American Society for Testing and Materials (ASTM): Develops and publishes standards for various industries, including pharmaceuticals.

    • These organizations work together to ensure that standards are developed and maintained in a way that ensures safety and efficacy.

    Why This Test is Needed

    The USP <2071> standard requires testing of injectable gels to determine the release rate of solid medicaments. This is essential to ensure that patients receive the correct dose of medication, thereby minimizing the risk of adverse reactions or treatment failures.

    Inadequate testing can lead to serious consequences, including:

  • Ineffective treatment

  • Adverse reactions

  • Treatment failure

  • Product recalls

    • The pharmaceutical industry relies on accurate and reliable testing to ensure product safety and efficacy. Failure to perform this test can result in significant financial losses and damage to reputation.

    The USP <2071> standard requires that testing be performed under specific conditions, including:

  • Temperature: 25C 2C

  • Humidity: 60 5

  • Pressure: 101.3 kPa 1.3 kPa

  • Sample preparation: Samples are prepared according to the manufacturers instructions.

    • The testing procedure involves the following steps:

    1. Sample preparation

    2. Testing of release rate

    3. Measurement and analysis

    4. Calibration and validation

    Eurolab uses state-of-the-art equipment, including spectrophotometers and chromatographs, to perform this test with precision and accuracy. Our experienced technicians are trained in the latest methodologies and techniques, ensuring that testing is performed according to the USP <2071> standard.

    Test results are documented and reported in a clear and concise manner, following the format outlined in the USP <2071> standard. The report includes:

  • Test conditions

  • Sample preparation details

  • Testing parameters

  • Results

  • Conclusion

    • Eurolabs reporting system is designed to ensure that test results are accurately recorded and communicated to clients. Our electronic reporting system allows for quick access to test data, making it easier to track and analyze results.

    Performing the USP <2071> drug release testing for injectable gels has numerous benefits, including:

  • Quality assurance and compliance

  • Risk assessment and mitigation

  • Competitive advantages and market positioning

  • Cost savings and efficiency improvements

  • Legal and regulatory compliance benefits

  • Customer confidence and trust building

  • International market access and trade facilitation

  • Innovation and research development support

    • By performing this test, companies can ensure that their products meet the necessary quality and safety standards, thereby protecting patients from potential harm.

    Why Eurolab is the Best Choice

    Eurolab has been providing laboratory testing services for over 20 years, with a reputation for accuracy, reliability, and precision. Our experienced technicians are trained in the latest methodologies and techniques, ensuring that testing is performed according to the USP <2071> standard.

    We offer flexible scheduling, quick turnaround times, and competitive pricing, making us an attractive choice for companies seeking laboratory testing services.

    In conclusion, the USP <2071> drug release testing for injectable gels is a critical component of product development and quality control. By performing this test, companies can ensure that their products meet the necessary quality and safety standards, thereby protecting patients from potential harm.

    Eurolab is committed to delivering high-quality, reliable results that meet the stringent requirements of the pharmaceutical industry. Contact us today to learn more about our laboratory testing services and how we can help your company achieve its goals.

    Appendix

  • USP <2071> standard: Available for download on the USP website.

  • ISO 10993-12:2012: Biological evaluation of medical devices -- Part 12: Sample preparation and reference materials. (Available for purchase on the ISO website.)

  • ASTM E2187-08: Standard Test Method for Determination of the Release Rate of Solid Medicaments in Injectable Gels. (Available for purchase on the ASTM website.)

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