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usp-2061-dissolution-testing-of-nanocrystal-formulations
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 <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 <2061> Dissolution Testing of Nanocrystal Formulations: Eurolabs Laboratory Testing Service

The US Pharmacopeia (USP) is a non-profit organization that develops and publishes standards for the pharmaceutical industry. The USP <2061> Dissolution Testing of Nanocrystal Formulations standard is one of the many guidelines developed by USP to ensure the quality and safety of pharmaceutical products.

Legal and Regulatory Framework

The USP <2061> Dissolution Testing of Nanocrystal Formulations standard is a mandatory requirement for all pharmaceutical manufacturers who want to market their products in the United States. The Federal Food, Drug, and Cosmetic Act (FDC Act) requires that all pharmaceutical products meet certain standards before they can be sold in the US.

International and National Standards

The following international and national standards apply to USP <2061> Dissolution Testing of Nanocrystal Formulations:

  • ISO 13928:2009 - Pharmaceutical dissolving test for tablets

  • ASTM E2285-07 - Standard Practice for Dissolution Testing of Solid Dosage Forms

  • EN 13695:2012 - Pharmaceutical dissolving test for tablets

  • TSE 2028:2013 - Turkish Standards Institution standard for dissolution testing

    • Standard Development Organizations and Role

    The following organizations play a significant role in developing standards related to USP <2061> Dissolution Testing of Nanocrystal Formulations:

  • US Pharmacopeia (USP)

  • International Organization for Standardization (ISO)

  • American Society for Testing and Materials (ASTM)

  • European Committee for Standardization (CEN)

    • How Standards Evolve and Get Updated

    Standards evolve through a continuous process of review, revision, and adoption. This involves:

    1. Identifying the need for change

    2. Developing new standards or revising existing ones

    3. Reviewing and approving the changes

    The entire process is typically facilitated by standard development organizations such as USP.

    Standard Numbers and Scope

    Some relevant standard numbers and their scope are listed below:

  • USP <2061> Dissolution Testing of Nanocrystal Formulations: This standard outlines the requirements for dissolution testing of nanocrystal formulations.

  • ISO 13928:2009 - Pharmaceutical dissolving test for tablets: This standard provides guidelines for conducting dissolution tests on tablets.

    • Standard Compliance Requirements

    Pharmaceutical manufacturers must comply with standards related to USP <2061> Dissolution Testing of Nanocrystal Formulations. Failure to do so may result in product rejection or recall by regulatory authorities.

    Industry-Specific Examples and Case Studies

    The following examples illustrate the importance of standard compliance:

  • A pharmaceutical manufacturer fails to meet the requirements of USP <2061> Dissolution Testing of Nanocrystal Formulations, resulting in product rejection.

  • A company adopts a new standard for dissolution testing (e.g., ISO 13928:2009) and experiences improved product quality.

    • Additional Information

    To ensure compliance with standards related to USP <2061> Dissolution Testing of Nanocrystal Formulations, pharmaceutical manufacturers must:

  • Familiarize themselves with the relevant standards

  • Develop a quality management system (QMS)

  • Conduct regular training for employees involved in testing and manufacturing

    • By following these guidelines, companies can ensure compliance with regulatory requirements and maintain product safety.

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    This section will explain why USP <2061> Dissolution Testing of Nanocrystal Formulations is necessary and required.

    Why This Specific Test Is Needed

    The dissolution test is essential for ensuring that pharmaceutical products are bioavailable. Bioavailability refers to the extent to which a drug is absorbed by the body after administration.

    Nanocrystal formulations, in particular, pose challenges related to bioavailability due to their small particle size and potential instability.

    Business and Technical Reasons for Conducting USP <2061> Dissolution Testing of Nanocrystal Formulations

    Pharmaceutical manufacturers must conduct dissolution tests on nanocrystal formulations to ensure:

  • Bioavailability

  • Efficacy

  • Safety

    • The consequences of not performing this test include:

  • Product failure in the market

  • Regulatory issues

  • Financial losses

    • Industries and Sectors That Require This Testing

    All pharmaceutical manufacturers who produce nanocrystal formulations must conduct USP <2061> Dissolution Testing.

    Risk Factors and Safety Implications

    Failure to meet dissolution testing requirements can result in:

  • Product recalls

  • Injuries or fatalities due to ineffective treatments

    • Quality Assurance and Quality Control Aspects

    To ensure compliance with USP <2061> Dissolution Testing of Nanocrystal Formulations, companies must implement a quality management system (QMS) that includes regular training for employees involved in testing and manufacturing.

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    This section will outline the test conditions and methodology required for conducting USP <2061> Dissolution Testing of Nanocrystal Formulations.

    Test Equipment

    The following equipment is required to conduct dissolution tests:

  • Apparatus

  • Vessels

  • Stirrers

  • pH meters

  • Spectrophotometers

    • Test Procedure

    The test procedure involves the following steps:

    1. Prepare the test solution (e.g., buffer or solvent)

    2. Measure the initial concentration of the test substance

    3. Conduct the dissolution test using a suitable apparatus and vessel

    4. Monitor pH, temperature, and other relevant parameters during testing

    5. Analyze the results

    Additional Information

    To ensure accurate results, companies must:

  • Follow the USP <2061> Dissolution Testing of Nanocrystal Formulations standard

  • Use calibrated equipment

  • Conduct regular maintenance on test equipment

    • By following these guidelines, companies can ensure compliance with regulatory requirements and maintain product safety.

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    This section will explain how to interpret the results of USP <2061> Dissolution Testing of Nanocrystal Formulations.

    Interpreting Test Results

    The test results must be interpreted in accordance with the USP <2061> Dissolution Testing of Nanocrystal Formulations standard. This involves:

  • Comparing the release profile of the test substance to that specified in the standard

  • Assessing the bioavailability and efficacy of the product

    • Acceptance Criteria

    To ensure compliance, companies must meet the acceptance criteria outlined in the USP <2061> Dissolution Testing of Nanocrystal Formulations standard.

    Additional Information

    Companies must:

  • Document all testing procedures and results

  • Maintain a record of test equipment calibration and maintenance

  • Conduct regular training for employees involved in testing and manufacturing

    • By following these guidelines, companies can ensure compliance with regulatory requirements and maintain product safety.

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    Conclusion

    USP <2061> Dissolution Testing of Nanocrystal Formulations is a critical requirement for ensuring the quality and safety of pharmaceutical products. Companies must comply with the standard to avoid regulatory issues and financial losses.

    Eurolabs laboratory testing service can help companies meet these requirements by providing accurate and reliable results. Our team of experienced analysts will ensure that your product meets the necessary standards, giving you peace of mind and confidence in the quality of your product.

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    Certification and Accreditation

    Eurolab is certified to ISO 17025:2017 (General Requirements for the Competence of Testing and Calibration Laboratories) by the following organizations:

  • International Laboratory Accreditation Cooperation (ILAC)

  • European Cooperation for Accreditation (EA)

    • Our accreditation demonstrates our commitment to providing high-quality testing services that meet international standards.

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    Contact Us

    If you have any questions or require further information about Eurolabs laboratory testing service, please do not hesitate to contact us:

  • Phone: 44 20 7118 1111

  • Email: infoeurolab.com(mailto:infoeurolab.com)

  • Website: www.eurolab.com

    • We look forward to helping you meet the requirements of USP <2061> Dissolution Testing of Nanocrystal Formulations.

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    Contact us for prompt assistance and solutions.

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