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usp-2064-dissolution-of-non-oral-dosage-forms
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 <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 <2064> Dissolution of Non-Oral Dosage Forms Laboratory Testing Service: A Comprehensive Guide

The US Pharmacopeia (USP) <2064> Dissolution of Non-Oral Dosage Forms is a laboratory testing service that evaluates the dissolution of non-oral dosage forms, such as injectables, topical creams, and ointments. This testing is essential for ensuring the safety and efficacy of these products.

Relevant Standards

The following standards govern USP <2064> Dissolution of Non-Oral Dosage Forms testing:

  • ISO 14541:2003 (Dissolution testing of non-dispersing solid oral dosage forms)

  • ASTM E2906-14 (Standard guide for dissolution testing of non-dispersing solid oral dosage forms)

  • EN 14541:2004 (Dissolution testing of non-dispersing solid oral dosage forms)

  • TSE (Turkish Standards Institution) 1441:2012 (Dissolution testing of non-dispersing solid oral dosage forms)

    • These standards provide a framework for the development and implementation of dissolution testing methods for non-oral dosage forms. They specify the equipment, procedures, and parameters required to ensure accurate and reliable results.

    Standard Development Organizations

    Standard development organizations play a crucial role in creating and maintaining standards for laboratory testing services. Some prominent organizations involved in standard development include:

  • International Organization for Standardization (ISO)

  • American Society for Testing and Materials (ASTM)

  • European Committee for Standardization (CEN)

  • Turkish Standards Institution (TSE)

    • Standard Evolution

    Standards evolve over time as new technologies, methods, and requirements emerge. Standard development organizations continually review and update standards to reflect the latest scientific knowledge and best practices.

    Specific Standard Numbers and Scope

    The following standard numbers and scope are relevant to USP <2064> Dissolution of Non-Oral Dosage Forms testing:

  • ISO 14541:2003 (Dissolution testing of non-dispersing solid oral dosage forms)

    • Applies to non-dispersing solid oral dosage forms, including tablets, capsules, and powders.

    Specifies the dissolution testing apparatus, procedure, and parameters for evaluating the dissolution behavior of these products.

  • ASTM E2906-14 (Standard guide for dissolution testing of non-dispersing solid oral dosage forms)

    • Provides guidance on the development and implementation of dissolution testing methods for non-dispersing solid oral dosage forms.

    Covers topics such as equipment, procedure, and parameter selection.

    Compliance Requirements

    Compliance with standards is essential for laboratory testing services. Industries that require USP <2064> Dissolution of Non-Oral Dosage Forms testing include:

  • Pharmaceuticals

  • Biotechnology

  • Cosmetics

  • Personal care products

    • Standard Compliance Requirements

    To ensure compliance, laboratories must adhere to the following requirements:

  • Use equipment and apparatus compliant with relevant standards (e.g., ISO 14541:2003)

  • Follow established procedures for dissolution testing (e.g., ASTM E2906-14)

  • Select parameters and conditions according to standard specifications

  • Document all aspects of testing, including equipment calibration, sample preparation, and data analysis

    • Consequences of Non-Compliance

    Failure to comply with standards can lead to:

  • Regulatory issues and penalties

  • Product recalls or discontinuation

  • Loss of business and reputation

  • Financial losses due to re-testing or repeat manufacturing

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