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usp-2079-disintegration-test-for-multi-unit-pellet-systems
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 <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 <2079> Disintegration Test for Multi-Unit Pellet Systems: Eurolabs Laboratory Testing Service

The USP <2079> Disintegration Test for Multi-Unit Pellet Systems is a critical laboratory test that evaluates the disintegration properties of multi-unit pellet systems. This test is governed by several international and national standards, including:

  • ISO 9974:2017(E) - Packaging - Complete, filled transport packages and unit loads - Testing

  • ASTM D4169-16 - Standard Practice for Performance Testing of Shipping Containers

  • EN 12020-1:2006 - Packaging - Complete, filled transport packages and unit loads - Test methods for general requirements

  • TSE (Turkish Standards Institution) ISO 9974:2017(E)

  • Other relevant standards, such as ASTM D3073-18 and ISO 11607-1:2019

    • The legal and regulatory framework surrounding this testing service is complex and multifaceted. In the United States, for example, the FDA regulates multi-unit pellet systems under Title 21 of the Code of Federal Regulations (CFR), while in Europe, the European Medicines Agency (EMA) governs these products.

    International standards development organizations, such as ISO and ASTM, play a crucial role in establishing and maintaining global standards for laboratory testing. These organizations bring together experts from around the world to develop and update standards that reflect the latest scientific knowledge and technological advancements.

    Standards evolve and get updated periodically to reflect changes in technology, regulatory requirements, or industry practices. For example, the ISO 9974 standard has undergone several revisions since its initial publication in 1985. Compliance with these standards is mandatory for industries such as pharmaceuticals, cosmetics, and food processing.

    The USP <2079> Disintegration Test for Multi-Unit Pellet Systems is essential for ensuring the safety and efficacy of these products. This test assesses the disintegration properties of multi-unit pellet systems, which can affect their performance and stability in various environments.

    Business and technical reasons for conducting this test include:

  • Ensuring compliance with regulatory requirements

  • Verifying product quality and performance

  • Minimizing risk associated with product failure or recall

  • Enhancing customer confidence and trust

    • Consequences of not performing this test can be severe, including:

  • Product failure or recall due to inadequate disintegration properties

  • Regulatory non-compliance and fines

  • Loss of customer confidence and market share

  • Decreased revenue and profitability

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

  • Pharmaceutical industry (e.g., tablets, capsules)

  • Cosmetics industry (e.g., creams, lotions)

  • Food processing industry (e.g., packaging materials)

    • The risk factors associated with this testing include:

  • Product failure or recall

  • Regulatory non-compliance

  • Loss of customer confidence and market share

    • Quality assurance and quality control aspects of this test involve:

  • Ensuring that the test is performed in accordance with established standards and protocols

  • Verifying that the equipment and personnel are calibrated, qualified, and validated

  • Maintaining accurate records and documentation of test results

    • This test contributes to product safety and reliability by ensuring that multi-unit pellet systems disintegrate properly under various conditions.

    The USP <2079> Disintegration Test for Multi-Unit Pellet Systems involves the following steps:

    1. Sample preparation: The multi-unit pellet system is prepared according to established protocols.

    2. Testing equipment: A suitable testing apparatus, such as a disintegration tester or a dissolution tester, is used to measure the disintegration properties of the sample.

    3. Testing environment: The test is conducted in an environmentally controlled room with precise temperature, humidity, and pressure conditions.

    4. Sample size: A specific number of samples are tested according to established protocols.

    5. Measurement and analysis methods: The disintegration properties of the sample are measured using various techniques, such as time, weight, or volume.

    The testing equipment used for this test includes:

  • Disintegration testers (e.g., USP <2079> tester)

  • Dissolution testers (e.g., USP <711> tester)

  • pH meters

  • Temperature control systems

    • The testing environment requirements include:

  • Temperature: 20C 5C

  • Humidity: 50 RH 10

  • Pressure: atmospheric pressure

    • The test results are documented and reported in accordance with established protocols. The report format and structure include:

  • Introduction

  • Test methodology

  • Results

  • Discussion

  • Conclusion

  • Recommendations

    • The interpretation of test results involves:

  • Verifying that the test was performed according to established standards and protocols

  • Evaluating the disintegration properties of the sample based on the test results

  • Identifying any deviations from expected performance

    • Accurate records and documentation of test results are essential for ensuring compliance with regulatory requirements and maintaining product quality.

    Conclusion

    The USP <2079> Disintegration Test for Multi-Unit Pellet Systems is a critical laboratory test that evaluates the disintegration properties of these products. This test is governed by various international and national standards, and its importance cannot be overstated.

    By performing this test according to established protocols and using suitable testing equipment, industries can ensure compliance with regulatory requirements, verify product quality and performance, and minimize risk associated with product failure or recall.

    Eurolabs laboratory testing service offers a comprehensive range of testing services for multi-unit pellet systems, including the USP <2079> Disintegration Test. Our expert technicians and state-of-the-art equipment ensure accurate and reliable results that meet the highest standards of quality and regulatory compliance.

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