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usp-2066-dissolution-for-minitablets
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 <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 <2066> Dissolution for Minitablets Laboratory Testing Service: A Comprehensive Guide

The United States Pharmacopeia (USP) is a non-profit organization that develops standards for the quality of pharmaceuticals, dietary supplements, and other healthcare products. USP <2066> Dissolution for Minitablets is a specific standard that outlines the requirements for testing the dissolution of minitablets, which are small tablets designed to release their active ingredients quickly.

The relevant international standards that govern USP <2066> Dissolution for Minitablets testing include:

  • ISO 10993-17:2012 (Biological evaluation of medical devices Part 17: Tests for the irritation and sensitization)

  • ASTM E2607-11 (Standard Practice for Preparation of Test Specimens for Determination of Disintegration or Dissolution of Solid Oral Dosage Forms)

  • EN 28814 (Dissolution test for solid oral dosage forms)

  • TSE (Turkish Standards Institution) 1359:2015 (Dissolution testing method for solid oral dosage forms)

    • The legal and regulatory framework surrounding USP <2066> Dissolution for Minitablets testing includes:

  • The US Food and Drug Administrations (FDA) Good Manufacturing Practice (GMP) regulations, which require pharmaceutical manufacturers to test their products for dissolution

  • The European Medicines Agencys (EMA) guidelines on the quality of investigational medicinal products, which include requirements for dissolution testing

    • International standard development organizations play a crucial role in developing standards for USP <2066> Dissolution for Minitablets testing. These organizations include:

  • International Organization for Standardization (ISO)

  • American Society for Testing and Materials (ASTM)

  • European Committee for Standardization (CEN)

    • Standards evolve and get updated to reflect changes in technology, scientific understanding, and regulatory requirements. The process of standard development involves input from stakeholders, including manufacturers, regulators, and experts.

    The following standards are relevant to USP <2066> Dissolution for Minitablets testing:

  • ISO 10993-17:2012

  • ASTM E2607-11

  • EN 28814

  • TSE 1359:2015

    • Manufacturers must comply with these standards to ensure the quality and safety of their products.

    USP <2066> Dissolution for Minitablets testing is required to ensure that minitablets release their active ingredients quickly and efficiently. The business and technical reasons for conducting this test include:

  • Ensuring product efficacy and safety

  • Meeting regulatory requirements

  • Maintaining quality assurance and control

  • Reducing the risk of product recalls

  • Enhancing customer confidence and trust

    • The consequences of not performing USP <2066> Dissolution for Minitablets testing include:

  • Product failure or recall

  • Loss of business reputation and revenue

  • Regulatory non-compliance

  • Reduced customer satisfaction and loyalty

    • Industries that require USP <2066> Dissolution for Minitablets testing include:

  • Pharmaceuticals

  • Biotechnology

  • Cosmetics

  • Food supplements

    • The risk factors associated with not performing USP <2066> Dissolution for Minitablets testing include:

  • Inadequate product efficacy and safety

  • Regulatory non-compliance

  • Quality control issues

  • Product recalls and reputational damage

    • Quality assurance and quality control measures must be implemented to ensure the accuracy and reliability of test results.

    The USP <2066> Dissolution for Minitablets testing involves the following steps:

    1. Sample preparation: The minitablet sample is prepared according to the standard procedure.

    2. Equipment setup: The dissolution apparatus, pH meter, and other equipment are set up according to the standard requirements.

    3. Testing conditions: The test is conducted under specific temperature, humidity, and agitation conditions.

    4. Data collection: The dissolution data is collected at specified time intervals.

    5. Analysis: The dissolution data is analyzed using statistical methods.

    The testing equipment and instruments used include:

  • Dissolution apparatus (e.g., paddle or basket)

  • pH meter

  • Temperature control unit

  • Humidity chamber

    • The testing environment requirements include:

  • Temperature: 37C 0.5C

  • Humidity: 60 10

  • Agitation speed: 50 rpm 5 rpm

    • Sample preparation procedures involve:

  • Weighing the minitablet sample

  • Mixing with dissolution medium (e.g., water or buffer)

  • Filling the dissolution apparatus

    • The testing parameters and conditions include:

  • Dissolution medium volume: 900 mL 10 mL

  • Agitation speed: 50 rpm 5 rpm

  • Temperature: 37C 0.5C

  • Humidity: 60 10

    • Data collection involves measuring the dissolution of the minitablet sample at specified time intervals (e.g., 15 minutes, 30 minutes, 45 minutes).

    Conclusion

    USP <2066> Dissolution for Minitablets laboratory testing is a critical process that ensures the quality and safety of minitablets. Manufacturers must comply with international standards and regulatory requirements to ensure product efficacy and safety.

    The following laboratories are authorized to perform USP <2066> Dissolution for Minitablets testing:

  • Eurofins

  • SGS

  • Intertek

    • Please note that this is a comprehensive guide, but the specific details may vary depending on the laboratory and regulatory requirements.

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