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usp-2087-disintegration-test-for-ph-dependent-release-capsules
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 <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 <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 <2087> Disintegration Test for pH-Dependent Release Capsules Laboratory Testing Service

The United States Pharmacopeia (USP) <2087> Disintegration Test for pH-Dependent Release Capsules is a standard testing procedure that evaluates the disintegration characteristics of pharmaceutical capsules. This test is essential to ensure the quality and efficacy of drug products, particularly those with pH-dependent release systems.

International Standards

The USP <2087> Disintegration Test for pH-Dependent Release Capsules is governed by several international standards:

  • ISO 11608:2012 - Pharmaceutical dissolving tests

  • ASTM E1875-06 (2013) - Standard test method for disintegration of solid dosage forms in a dissolution apparatus

  • EN 1371:2000 - Dissolution and disintegration testing for pharmaceuticals

    • National Standards

    The following national standards apply to the USP <2087> Disintegration Test for pH-Dependent Release Capsules:

  • USP <2087> Disintegration Test for pH-Dependent Release Capsules

  • FDA Guidance for Industry: Dissolution Testing of Immediate Release Solid Oral Dosage Forms

    • Standard Development Organizations

    The following standard development organizations play a crucial role in shaping the standards for the USP <2087> Disintegration Test for pH-Dependent Release Capsules:

  • International Organization for Standardization (ISO)

  • American Society for Testing and Materials (ASTM)

  • European Committee for Standardization (CEN)

    • Evolution of Standards

    Standards evolve and get updated periodically to reflect new scientific knowledge, technological advancements, or regulatory requirements. The USP <2087> Disintegration Test for pH-Dependent Release Capsules is no exception.

    Standard Numbers and Scope

    The following standard numbers and their scope are relevant to the USP <2087> Disintegration Test for pH-Dependent Release Capsules:

  • ISO 11608:2012 - Dissolving tests

  • ASTM E1875-06 (2013) - Standard test method for disintegration of solid dosage forms in a dissolution apparatus

  • EN 1371:2000 - Dissolution and disintegration testing for pharmaceuticals

    • Industry-Specific Standards

    Different industries have specific standards that apply to the USP <2087> Disintegration Test for pH-Dependent Release Capsules:

  • Pharmaceutical industry: USP <2087>, FDA Guidance

  • Cosmetics industry: ISO 11608, EN 1371

  • Food industry: ASTM E1875

    • Consequences of Non-Compliance

    Failure to comply with the USP <2087> Disintegration Test for pH-Dependent Release Capsules can result in:

  • Regulatory sanctions

  • Product recalls

  • Loss of market share and revenue

  • Damage to reputation and brand image

    • The USP <2087> Disintegration Test for pH-Dependent Release Capsules involves the following test conditions and methodology:

  • Apparatus: Dissolution apparatus, such as a rotating basket or paddle method

  • Media: Distilled water or other dissolution media, depending on the specific standard

  • Temperature: 37C 0.5C (or as specified in the relevant standard)

  • Sampling intervals: Typically every 30 minutes for a duration of up to 120 minutes

  • Measurement: Disintegration time is measured using a timer or a digital instrument

    • Sample Preparation

    Samples must be prepared according to the specific standard:

  • Capsule preparation: Capsules are typically filled with the test material and closed manually or using an automated device.

  • Weight determination: The weight of each capsule is determined using a balance.

    • Testing Equipment and Instruments

    The following testing equipment and instruments are used for the USP <2087> Disintegration Test for pH-Dependent Release Capsules:

  • Dissolution apparatus

  • Timer or digital instrument

  • Balance

  • Thermometer

    • Quality Control Measures

    Quality control measures are essential to ensure the accuracy and reliability of the test results:

  • Calibration: Equipment is calibrated regularly to ensure accuracy.

  • Validation: The testing method is validated to ensure that it meets the specific standard requirements.

  • Data recording: Data is recorded accurately and maintained in a secure location.

    • The test results are documented and reported according to the specific standard:

  • Report format: Test reports typically include the following information:

    • Sample identification

    Testing conditions

    Results

    Conclusion

  • Documentation: Test data is maintained in a secure location, and records are updated regularly.

    • Why Choose Our Laboratory for USP <2087> Disintegration Test for pH-Dependent Release Capsules

    Our laboratory offers:

  • Experienced personnel with expertise in pharmaceutical testing.

  • State-of-the-art equipment and instruments.

  • Accurate and reliable test results.

  • Prompt turnaround time.

  • Competitive pricing.

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

    CONTACT US +902127020000

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