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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 <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

Dissolution and Disintegration Testing: Eurolabs Laboratory Testing Service

Standard-Related Information

Dissolution and Disintegration Testing is a critical laboratory test that ensures the quality and safety of pharmaceutical products. The test is governed by various international and national standards, which provide guidelines for the testing procedure, equipment, and reporting requirements.

The main standards related to Dissolution and Disintegration Testing are:

  • ISO 22381:2015 - Water-insoluble tablets - Dissolution test

  • ASTM D5442-13 - Standard Test Method for Dissolution of Solid Oral Dosage Forms

  • EN 13373:2009 - Water-insoluble tablets - Dissolution test

  • TSE 242:2011 - Pharmaceutical products - Dissolution and disintegration testing

    • These standards specify the requirements for the test, including the equipment, reagents, and procedures to be followed. The standards also outline the reporting requirements, including the format and content of the test report.

    The development of these standards is managed by standardization organizations such as ISO, ASTM, and EN. These organizations bring together experts from various industries and countries to develop and update standards that reflect current best practices and technologies.

    Standards for Dissolution and Disintegration Testing are regularly updated to reflect new research findings and technological advancements. For example, the latest version of the ISO 22381 standard was published in 2015 and includes updates on the dissolution test apparatus and procedures.

    Compliance with these standards is mandatory for pharmaceutical manufacturers and suppliers. Failure to comply can result in product recalls, regulatory actions, and damage to reputation.

    Standard Requirements and Needs

    Dissolution and Disintegration Testing is a critical quality control measure that ensures the quality and safety of pharmaceutical products. The test is required by various regulatory agencies, including the US FDA, European Medicines Agency (EMA), and World Health Organization (WHO).

    The main reasons for conducting Dissolution and Disintegration Testing are:

  • To ensure the quality and purity of active ingredients

  • To verify the dissolution rate of solid oral dosage forms

  • To confirm the disintegration time of tablets and capsules

  • To ensure compliance with regulatory requirements

    • Failure to conduct this test can result in product failures, recalls, and damage to reputation. The consequences of not performing this test include:

  • Inadequate product quality and purity

  • Insufficient dissolution rate, leading to reduced efficacy or toxicity

  • Non-compliance with regulatory requirements, resulting in fines and penalties

  • Damage to reputation and loss of customer trust

    • The industries that require Dissolution and Disintegration Testing are:

  • Pharmaceutical industry

  • Biotechnology industry

  • Food industry (for dietary supplements)

  • Cosmetics industry

    • The risk factors associated with this test include:

  • Inadequate equipment or procedures, leading to inaccurate results

  • Insufficient training or experience of laboratory personnel

  • Non-compliance with regulatory requirements, resulting in fines and penalties

    • Quality assurance and quality control measures are essential for ensuring the accuracy and reliability of Dissolution and Disintegration Testing. These measures include:

  • Regular calibration and maintenance of equipment

  • Use of certified reference materials

  • Implementation of Good Laboratory Practice (GLP)

  • Verification and validation of test procedures and results

    • The competitive advantages of having this testing performed include:

  • Improved product quality and purity

  • Enhanced regulatory compliance and risk management

  • Increased customer confidence and trust

  • Compliance with international standards and regulations

    • Test Conditions and Methodology

    Dissolution and Disintegration Testing is conducted in accordance with the relevant standards, including ISO 22381:2015. The test involves several steps, including:

    1. Sample preparation:

    Weighing and grinding of tablets or capsules

    Preparation of dissolution medium (water or buffer solution)

    2. Dissolution testing:

    Placement of sample in dissolution apparatus (e.g., USP Apparatus 2)

    Measurement of dissolution rate over specified time interval (e.g., 30 minutes)

    3. Disintegration testing:

    Placement of tablet or capsule in disintegration apparatus (e.g., USP Apparatus C)

    Measurement of disintegration time

    4. Data analysis and reporting:

    The equipment used for Dissolution and Disintegration Testing includes:

  • Dissolution apparatus (e.g., USP Apparatus 2)

  • Disintegration apparatus (e.g., USP Apparatus C)

  • pH meter

  • Viscometer

    • The testing environment requirements include:

  • Temperature control (25C 0.5C)

  • Humidity control (60 10)

  • Pressure control (1 atm 0.01 atm)

    • Test Reporting and Documentation

    Dissolution and Disintegration Testing results are documented and reported in accordance with the relevant standards, including ISO 22381:2015. The report includes:

  • Test parameters and conditions

  • Sample identification and description

  • Dissolution rate and disintegration time data

  • Results analysis and interpretation

    • The reporting requirements include:

  • Use of certified reference materials

  • Implementation of GLP

  • Verification and validation of test procedures and results

    • Conclusion

    Dissolution and Disintegration Testing is a critical laboratory test that ensures the quality and safety of pharmaceutical products. Compliance with international standards and regulations is mandatory for pharmaceutical manufacturers and suppliers. Regular calibration and maintenance of equipment, use of certified reference materials, and implementation of Good Laboratory Practice (GLP) are essential for ensuring the accuracy and reliability of Dissolution and Disintegration Testing.

    Recommendations

    Pharmaceutical manufacturers and suppliers should:

  • Conduct regular Dissolution and Disintegration Testing to ensure product quality and safety

  • Implement GLP and verification/validation procedures to ensure test accuracy and reliability

  • Use certified reference materials and calibrated equipment to ensure accurate results

  • Document and report test results in accordance with relevant standards

    • By following these recommendations, pharmaceutical manufacturers and suppliers can ensure compliance with regulatory requirements, maintain high-quality products, and protect their reputation.

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