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usp-1002-dissolution-testing-for-powder-filled-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 <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 <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 <1002> Dissolution Testing for Powder-Filled Capsules: Laboratory Testing Services

The United States Pharmacopeia (USP) <1002> dissolution testing for powder-filled capsules is a crucial laboratory test that ensures the quality and safety of pharmaceutical products. This article provides an in-depth look at the relevant standards, regulatory framework, and international requirements governing this testing service.

Relevant Standards

  • ISO 10993-1:2018 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process

  • ASTM E2875-11 Standard Guide for Testing of Solid Oral Dosage Forms

  • EN ISO 10993-10:2010 Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization

  • TSE (Turkish Standards Institution) TS 13581:2018 Biological evaluation of medical devices

  • USP <1002> Dissolution Testing for Powder-Filled Capsules

    • Legal and Regulatory Framework

    The Food and Drug Administration (FDA), the European Medicines Agency (EMA), and other regulatory agencies worldwide require pharmaceutical companies to conduct dissolution testing on powder-filled capsules as part of their quality control procedures. Non-compliance with these regulations can result in product recalls, fines, or even market withdrawal.

    International and National Standards

  • ISO 9001:2015 Quality management systems Requirements

  • ASTM E1383-11 Standard Guide for Testing of Solid Oral Dosage Forms

  • EN ISO 10993-10:2010 Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization

  • USP <1002> Dissolution Testing for Powder-Filled Capsules

    • Standard Development Organizations

    The International Organization for Standardization (ISO), the American Society for Testing and Materials (ASTM), and the European Committee for Standardization (CEN) are prominent standard development organizations that create, update, and maintain standards related to dissolution testing.

    Evolution of Standards

    Standards evolve through a continuous process of review, revision, and updates. This ensures that laboratory tests remain relevant, accurate, and effective in maintaining product quality and safety.

    Standard Numbers and Scope

    USP <1002> Dissolution Testing for Powder-Filled Capsules (1.0) outlines the requirements for testing powder-filled capsules using a dissolution apparatus. The standard specifies the test conditions, equipment, and procedures for conducting dissolution tests on these products.

    Compliance Requirements

    Pharmaceutical companies must comply with national and international standards related to dissolution testing, including USP <1002>. Failure to do so can result in product recalls, fines, or market withdrawal.

    Why This Specific Test is Needed and Required

    Dissolution testing for powder-filled capsules is essential to ensure the quality and safety of pharmaceutical products. The test helps to assess the bioavailability, solubility, and stability of these products, which are critical factors in maintaining product efficacy and preventing adverse reactions.

    Business and Technical Reasons for Conducting USP <1002> Dissolution Testing

    Pharmaceutical companies must conduct dissolution testing on powder-filled capsules as part of their quality control procedures to:

  • Ensure product safety and efficacy

  • Comply with regulatory requirements

  • Prevent product recalls and fines

  • Maintain market share and customer trust

    • Consequences of Not Performing This Test

    Failure to conduct USP <1002> dissolution testing can result in:

  • Product recalls and fines

  • Loss of market share and customer trust

  • Regulatory non-compliance

  • Increased risk of adverse reactions and product failures

    • Industries and Sectors that Require This Testing

    Pharmaceutical companies, regulatory agencies, and quality control organizations require dissolution testing on powder-filled capsules.

    Risk Factors and Safety Implications

    Failure to conduct dissolution testing can result in:

  • Adverse reactions and product failures

  • Loss of product efficacy and potency

  • Regulatory non-compliance

    • Quality Assurance and Quality Control Aspects

    Dissolution testing for powder-filled capsules involves a series of quality control procedures, including sample preparation, equipment calibration, and data analysis.

    Contribution to Product Safety and Reliability

    Dissolution testing helps to ensure the safety and efficacy of pharmaceutical products by assessing their bioavailability, solubility, and stability.

    Competitive Advantages of Having This Testing Performed

    Pharmaceutical companies that conduct dissolution testing on powder-filled capsules can:

  • Maintain market share and customer trust

  • Ensure regulatory compliance

  • Prevent product recalls and fines

    • Cost-Benefit Analysis of Performing This Test

    The cost-benefit analysis of conducting USP <1002> dissolution testing is favorable, as it helps to prevent product recalls, fines, and regulatory non-compliance.

    Test Conditions

    Dissolution testing for powder-filled capsules involves a series of test conditions, including:

  • Temperature

  • pH

  • Rotation speed

    • Equipment and Materials

    The equipment and materials required for dissolution testing include:

  • Dissolution apparatus

  • Measuring cups and cylinders

  • pH meters

    • Procedures

    The procedures involved in conducting dissolution testing include:

  • Sample preparation

  • Equipment calibration

  • Data analysis

    • Data Analysis

    The data collected from dissolution testing is analyzed to assess the bioavailability, solubility, and stability of powder-filled capsules.

    Interpretation of Results

    The results of dissolution testing are interpreted to ensure that pharmaceutical products meet regulatory requirements and maintain product quality and safety.

    Conclusion

    USP <1002> dissolution testing for powder-filled capsules is a critical laboratory test that ensures the quality and safety of pharmaceutical products. Pharmaceutical companies must comply with national and international standards related to dissolution testing, including USP <1002>, to prevent product recalls, fines, and regulatory non-compliance.

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    This article has provided an in-depth look at the relevant standards, regulatory framework, and international requirements governing USP <1002> dissolution testing for powder-filled capsules. It is essential that pharmaceutical companies understand the importance of this testing and comply with national and international standards related to dissolution testing.

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