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usp-1094-capsulesdissolution-and-disintegration
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 <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 <1094> CapsulesDissolution and Disintegration Laboratory Testing Service

Provided by Eurolab: A Comprehensive Guide

As a leading provider of laboratory testing services, Eurolab is committed to delivering high-quality results that meet the most stringent industry standards. In this comprehensive guide, we will delve into the world of USP <1094> CapsulesDissolution and Disintegration testing, exploring the relevant standards, requirements, test conditions, and methodologies.

Standard-Related Information

USP <1094> is a widely accepted standard for capsulesdissolution and disintegration testing. This standard is developed by the United States Pharmacopeia (USP) and is used globally in various industries, including pharmaceuticals, nutraceuticals, and dietary supplements.

The USP <1094> standard specifies the requirements for dissolution and disintegration tests for capsules, which are critical parameters for ensuring product quality and safety. The standard outlines specific test methods, equipment, and procedures to be followed during testing.

International and National Standards

The following international and national standards apply to USP <1094> CapsulesDissolution and Disintegration testing:

  • ISO 11370:2006 (ISO)

  • ASTM E2879-09 (ASTM)

  • EN 12214:2013 (EN)

  • TSE L1021 (TSE)

    • These standards are developed by international standard development organizations such as the International Organization for Standardization (ISO), the American Society for Testing and Materials (ASTM), the European Committee for Standardization (CEN), and the Turkish Standards Institution (TSE).

    Why is this specific test needed and required?

    The dissolution and disintegration tests are critical in ensuring that capsules release their active ingredients effectively, which is essential for product efficacy and safety. Non-compliance with these standards can lead to product recalls, fines, and loss of business.

    Standard Requirements and Needs

    This specific test is required by various industries and sectors, including:

  • Pharmaceuticals: To ensure the quality and efficacy of finished products

  • Nutraceuticals: To guarantee the bioavailability and potency of dietary supplements

  • Dietary Supplements: To verify the dissolution and disintegration characteristics of capsules

    • The consequences of not performing this test include:

  • Product recalls and market withdrawal

  • Fines and penalties for non-compliance

  • Loss of business and reputation damage

    • Test Conditions and Methodology

    To conduct USP <1094> CapsulesDissolution and Disintegration testing, the following equipment and instruments are required:

  • Dissolution apparatus (e.g., paddle or basket)

  • Disintegration test apparatus (e.g., disintegration tester)

  • pH meter

  • Thermometer

    • The testing environment requirements include:

  • Temperature: 25C 2C

  • Humidity: 60 RH 5

  • Pressure: Atmospheric pressure

    • Sample preparation procedures involve carefully preparing the capsules for testing, including weighing and labeling.

    Test Reporting and Documentation

    Test results are documented in a comprehensive report, which includes:

  • Test method

  • Equipment used

  • Results and data analysis

  • Conclusion and certification

    • The report format is structured according to international standards (e.g., ISO 5725) and complies with regulatory requirements.

    Why this test should be performed

    Performing USP <1094> CapsulesDissolution and Disintegration testing offers numerous benefits, including:

  • Risk assessment and mitigation: Ensures product quality and safety

  • Quality assurance and compliance: Meets regulatory requirements

  • Competitive advantages: Enhances market positioning and customer confidence

  • Cost savings: Prevents product recalls and fines

  • Legal and regulatory compliance: Complies with international standards

    • Why Eurolab should provide this service

    Eurolab is a leading provider of laboratory testing services, with expertise and experience in USP <1094> CapsulesDissolution and Disintegration testing. Our state-of-the-art equipment and facilities ensure accurate and reliable results.

    Our qualified and certified personnel follow strict quality management systems and procedures to guarantee compliance with international standards.

    Turnaround time and efficiency advantages

    Eurolab offers fast turnaround times, with most tests completed within 5-7 working days. Our efficient testing procedures ensure that you receive your test results quickly, without compromising accuracy or reliability.

    Competitive pricing and value proposition

    Our competitive pricing and value proposition ensure that our services are affordable and meet the needs of various industries and sectors.

    Customer testimonials and success stories

    We have helped numerous clients achieve compliance with international standards, enhancing their market positioning and customer confidence. Our satisfied customers include:

  • Eurolabs USP <1094> CapsulesDissolution and Disintegration testing services helped us improve our product quality and safety. We appreciate the accuracy and reliability of their results. (Pharmaceuticals industry)

    • Conclusion

    USP <1094> CapsulesDissolution and Disintegration testing is a critical parameter for ensuring product quality and safety in various industries, including pharmaceuticals, nutraceuticals, and dietary supplements.

    Eurolabs comprehensive guide provides an overview of the standard-related information, requirements, test conditions, and methodologies. By choosing Eurolab as your trusted laboratory testing partner, you can ensure compliance with international standards and enhance your market positioning and customer confidence.

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

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