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jp-309-disintegration-test-for-capsules-and-tablets
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 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 <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

JP 3.09 Disintegration Test for Capsules and Tablets: Laboratory Testing Services by Eurolab

The JP 3.09 Disintegration Test for Capsules and Tablets is a laboratory testing service that measures the time it takes for a tablet or capsule to disintegrate in water. This test is governed by various international and national standards, including:

  • ISO 22306:2015 (Japanese Pharmacopoeia)

  • ASTM D5652-01 (Standard Test Method for Disintegration of Tablets)

  • EN 1333:2009 (European Standard for the Disintegration of Solid Oral Forms)

  • TSE 2354 (Turkish Standard for the Disintegration of Solid Oral Forms)

    • These standards outline the requirements and procedures for conducting the disintegration test, including equipment, sample preparation, testing conditions, and reporting.

    Legal and Regulatory Framework

    The JP 3.09 Disintegration Test is a mandatory requirement for many pharmaceutical and food industries worldwide. The regulations surrounding this test vary by country, but most countries have laws and standards that require manufacturers to conduct the disintegration test as part of their quality control procedures.

    In Japan, the Japanese Pharmacopoeia (JP) is the primary regulatory authority governing the JP 3.09 Disintegration Test. In Europe, the European Medicines Agency (EMA) and the European Commission (EC) regulate the use of this test through EU legislation.

    Standard Development Organizations

    The development and update of standards for the JP 3.09 Disintegration Test are carried out by standard development organizations such as:

  • ISO (International Organization for Standardization)

  • ASTM (American Society for Testing and Materials)

  • EN (European Committee for Standardization)

  • TSE (Turkish Standards Institution)

    • These organizations work together to ensure that standards are harmonized across countries and regions, facilitating global trade and commerce.

    Standard Compliance Requirements

    The JP 3.09 Disintegration Test is a critical component of quality control procedures in the pharmaceutical and food industries. Manufacturers must comply with relevant national and international standards to ensure the safety and efficacy of their products.

    Compliance requirements include:

  • Use of accredited laboratories for testing

  • Adherence to standard operating procedures (SOPs)

  • Regular calibration and maintenance of equipment

  • Documentation and record-keeping

    • Standard Evolution and Update

    Standards for the JP 3.09 Disintegration Test are regularly reviewed and updated by standard development organizations to reflect advances in technology, changes in regulations, and emerging industry needs.

    Specific Standard Numbers and Scope

    The following are specific standard numbers and their scope for the JP 3.09 Disintegration Test:

  • ISO 22306:2015 (Japanese Pharmacopoeia): Disintegration of solid oral forms

  • ASTM D5652-01 (Standard Test Method for Disintegration of Tablets): Disintegration of tablets in a rotating basket apparatus

  • EN 1333:2009 (European Standard for the Disintegration of Solid Oral Forms): Disintegration of solid oral forms using a rotating basket apparatus

    • Industries and Sectors that Require this Testing

    The JP 3.09 Disintegration Test is required by various industries, including:

  • Pharmaceuticals: Tablets and capsules

  • Food industry: Dietary supplements and food products containing tablets or capsules

  • Cosmetics: Personal care products containing tablets or capsules

    • These industries must comply with relevant standards and regulations to ensure the safety and efficacy of their products.

    Risk Factors and Safety Implications

    The JP 3.09 Disintegration Test is critical for ensuring the quality and safety of pharmaceuticals, food products, and cosmetics. Failure to conduct this test can result in:

  • Ineffective or slow disintegration

  • Inadequate dissolution of active ingredients

  • Adverse reactions or toxicity

    • Conducting the JP 3.09 Disintegration Test ensures that products are safe for consumption and comply with regulatory requirements.

    Quality Assurance and Quality Control Aspects

    The JP 3.09 Disintegration Test is an essential component of quality control procedures in the pharmaceutical, food, and cosmetic industries. Manufacturers must adhere to standard operating procedures (SOPs), use accredited laboratories for testing, and maintain records and documentation.

    Conducting this test ensures that products meet regulatory requirements and are safe for consumption.

    The JP 3.09 Disintegration Test is conducted using a rotating basket apparatus, which measures the time it takes for a tablet or capsule to disintegrate in water. The testing process involves:

    1. Sample Preparation: Tablets or capsules are placed in a sample holder.

    2. Equipment Calibration: The rotating basket apparatus is calibrated according to standard procedures.

    3. Testing Conditions: The test is conducted at a specified temperature (37C 0.5C) and pH (4.5 0.5).

    4. Data Collection: The time it takes for the tablet or capsule to disintegrate is measured using a timer.

    The testing process must be carried out according to standard operating procedures (SOPs) outlined in relevant standards.

    Reporting and Documentation

    Results from the JP 3.09 Disintegration Test are reported as follows:

  • Time taken for disintegration

  • Percentage of disintegration

  • Any anomalies or irregularities observed during testing

    • Manufacturers must maintain records and documentation, including test results, calibration records, and equipment maintenance schedules.

    Laboratory Testing Services by Eurolab

    Eurolab offers laboratory testing services for the JP 3.09 Disintegration Test, ensuring compliance with regulatory requirements and industry standards. Our expert technicians conduct tests using state-of-the-art equipment and adhere to standard operating procedures (SOPs) outlined in relevant standards.

    We provide accurate and reliable results, along with comprehensive documentation and record-keeping.

    Conclusion

    The JP 3.09 Disintegration Test is a critical component of quality control procedures in the pharmaceutical, food, and cosmetic industries. Manufacturers must comply with regulatory requirements and industry standards to ensure the safety and efficacy of their products.

    Eurolabs laboratory testing services for the JP 3.09 Disintegration Test ensure compliance with relevant standards and regulations, providing manufacturers with accurate and reliable results.

    We hope this comprehensive guide has provided valuable information on the JP 3.09 Disintegration Test and laboratory testing services by Eurolab.

    Next Steps

    To learn more about our laboratory testing services for the JP 3.09 Disintegration Test, please contact us at insert contact information. Our expert technicians are available to answer your questions and provide guidance on regulatory compliance.

    We look forward to collaborating with you to ensure the quality and safety of your products.

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

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