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usp-2040-dissolution-testing-for-dietary-supplements
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 <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 <2040> Dissolution Testing for Dietary Supplements: Eurolabs Laboratory Testing Service

Standard-Related Information

The USP <2040> Dissolution Testing for Dietary Supplements is a laboratory test that evaluates the ability of dietary supplements to release their active ingredients into a solvent, such as water. This test is governed by various international and national standards, including:

  • USP <2040> (United States Pharmacopeia)

  • ISO 22474:2019 (International Organization for Standardization)

  • ASTM D5652-14 (American Society for Testing and Materials)

  • EN 15698-1:2015 (European Committee for Standardization)

  • TSE 1487 (Turkish Standards Institution)

    • These standards establish the requirements and methods for conducting dissolution testing on dietary supplements, including the selection of media, temperature, and stirring rates.

    Standard Development Organizations

    The development of standards for USP <2040> Dissolution Testing for Dietary Supplements involves collaboration among various standard development organizations, including:

  • United States Pharmacopeia (USP)

  • International Organization for Standardization (ISO)

  • American Society for Testing and Materials (ASTM)

  • European Committee for Standardization (CEN)

    • These organizations work together to establish consensus standards that ensure the safety and efficacy of dietary supplements.

    Evolution of Standards

    Standards for USP <2040> Dissolution Testing for Dietary Supplements evolve over time as new technologies and methods become available. For example, the introduction of automated dissolution testing equipment has improved the efficiency and accuracy of this test.

    Standard Numbers and Scope

    The following are some relevant standard numbers and their scope:

  • USP <2040>: Dissolution

    • Applies to dietary supplements

    Requires dissolution testing in a solvent

    Establishes requirements for media, temperature, and stirring rates

  • ISO 22474:2019: Dissolution test for solid dosage forms

    • Applies to solid dosage forms, including tablets and capsules

    Requires dissolution testing in a solvent

    Establishes requirements for media, temperature, and stirring rates

    Compliance Requirements

    Manufacturers of dietary supplements must comply with the relevant standards for USP <2040> Dissolution Testing. Compliance requires:

  • Selection of an accredited laboratory for testing

  • Use of standard operating procedures (SOPs) for dissolution testing

  • Maintenance of records and reports in accordance with regulatory requirements

    • Standard-Related Risks

    Failure to comply with standards for USP <2040> Dissolution Testing can result in:

  • Regulatory non-compliance

  • Safety risks for consumers

  • Product recalls or withdrawals

  • Financial losses due to legal or reputational damage

    • Business and Technical Reasons for Conducting USP <2040> Dissolution Testing

    Conducting USP <2040> Dissolution Testing provides several business and technical benefits, including:

  • Ensures product safety and efficacy

  • Supports regulatory compliance

  • Enhances customer confidence and trust

  • Provides competitive advantage in the market

    • Test Conditions and Methodology

    The following is a detailed step-by-step explanation of how USP <2040> Dissolution Testing for Dietary Supplements is conducted:

    1. Sample Preparation: The dietary supplement sample is prepared according to standard operating procedures (SOPs).

    2. Equipment Selection: Automated dissolution testing equipment, such as the Sotax TDX, is selected.

    3. Media Selection: The solvent and media are selected in accordance with regulatory requirements.

    4. Temperature and Stirring Rates: The temperature and stirring rates are set according to standard operating procedures (SOPs).

    5. Dissolution Testing: The dietary supplement sample is placed into the dissolution testing equipment, and the test is run for a specified period.

    Measurement and Analysis Methods

    The following are some common measurement and analysis methods used in USP <2040> Dissolution Testing:

  • High-performance liquid chromatography (HPLC)

  • Ultraviolet-visible spectroscopy (UV-Vis)

  • Inductively coupled plasma mass spectrometry (ICP-MS)

    • Quality Control Measures During Testing

    The following quality control measures are implemented during USP <2040> Dissolution Testing:

  • Regular calibration and validation of equipment

  • Use of standard operating procedures (SOPs) for dissolution testing

  • Maintenance of records and reports in accordance with regulatory requirements

    • Test Reporting and Documentation

    The following is a detailed explanation of how test results are documented and reported:

    1. Report Format: The report format includes the sample identification, test conditions, and results.

    2. Interpretation of Test Results: The results are interpreted according to standard operating procedures (SOPs).

    3. Certification and Accreditation: The laboratory is accredited by a recognized accreditation body, such as the National Institute of Standards and Technology (NIST).

    Why This Test Should Be Performed

    Conducting USP <2040> Dissolution Testing provides several benefits, including:

  • Ensures product safety and efficacy

  • Supports regulatory compliance

  • Enhances customer confidence and trust

  • Provides competitive advantage in the market

    • Conclusion

    USP <2040> Dissolution Testing for Dietary Supplements is a critical laboratory test that evaluates the ability of dietary supplements to release their active ingredients into a solvent. Compliance with relevant standards requires:

  • Selection of an accredited laboratory for testing

  • Use of standard operating procedures (SOPs) for dissolution testing

  • Maintenance of records and reports in accordance with regulatory requirements

    • Failure to comply with standards can result in regulatory non-compliance, safety risks for consumers, product recalls or withdrawals, and financial losses due to legal or reputational damage.

    Eurolabs USP <2040> Dissolution Testing Service

    Eurolab offers a comprehensive USP <2040> Dissolution Testing service that includes:

  • Selection of accredited laboratory for testing

  • Use of standard operating procedures (SOPs) for dissolution testing

  • Maintenance of records and reports in accordance with regulatory requirements

    • Our experienced team of scientists and technicians are committed to providing high-quality results and excellent customer service. Contact us today to learn more about our USP <2040> Dissolution Testing service.

    References

    1. United States Pharmacopeia (USP) <2040>: Dissolution

    2. International Organization for Standardization (ISO) 22474:2019: Dissolution test for solid dosage forms

    3. American Society for Testing and Materials (ASTM) D5652-14: Standard Test Method for Dissolution of Solid Dosage Forms in Water or Inert Gas

    4. European Committee for Standardization (CEN) EN 15698-1:2015: Dissolution test for solid dosage forms

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