EUROLAB
ph-eur-293-dissolution-testing-of-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. 2.9.39 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

Comprehensive Guide to Ph. Eur. 2.9.3 Dissolution Testing of Oral Dosage Forms Laboratory Testing Service by Eurolab

Ph. Eur. 2.9.3 Dissolution Testing of Oral Dosage Forms is a laboratory testing service that falls under the European Pharmacopoeia (Ph. Eur.) standards, specifically chapter 2.9.3. This chapter outlines the requirements for dissolution testing of oral dosage forms, ensuring that these products meet the necessary quality and safety standards.

Relevant Standards

The following standards are relevant to Ph. Eur. 2.9.3 Dissolution Testing of Oral Dosage Forms:

  • ISO 14644-1 (2015): Classification of air cleanliness by particle concentration

  • ASTM E748 (2004): Standard Test Methods for Determination of the Dissolution Rate of Solid Particulate Matter from Aqueous Solution under Stagnant Conditions

  • EN 12672 (2006): Pharmaceutical preparations - Dissolution test for solid oral dosage forms

  • TSE 1343 (2017): Turkish Standards Institution, Pharmaceutical Preparations - Dissolution Test for Solid Oral Dosage Forms

    • Legal and Regulatory Framework

    The European Pharmacopoeia is the official publication of the Council of Europes Directorate for the Quality of Medicines and Healthcare. Ph. Eur. 2.9.3 provides a framework for dissolution testing, ensuring that oral dosage forms meet quality standards. This includes:

  • European Union (EU) directives and regulations

  • International Conference on Harmonisation (ICH)

  • World Health Organization (WHO)

    • Standard Development Organizations

    The following organizations play a significant role in developing and maintaining Ph. Eur. 2.9.3:

  • European Pharmacopoeia Commission (Ph. Eur. Commission)

  • International Council for Laboratory Medicine (ICLM)

  • International Organization for Standardization (ISO)

  • American Society for Testing and Materials (ASTM)

    • Standard Evolution and Updates

    Standards evolve as new technologies, methods, and regulatory requirements emerge. This ensures that laboratory testing services remain current and compliant.

  • Ph. Eur. 2.9.3 has undergone revisions, including the introduction of new dissolution media and updated apparatus

  • The standard is subject to periodic review and update by the Ph. Eur. Commission

    • Standard Compliance Requirements

    Ph. Eur. 2.9.3 compliance is essential for various industries:

  • Pharmaceutical manufacturers must demonstrate compliance with EU regulations and ICH guidelines

  • Regulatory bodies, such as the European Medicines Agency (EMA), enforce compliance

  • Laboratories providing testing services must adhere to Ph. Eur. standards

    • Standard-Related Information Summary

    Ph. Eur. 2.9.3 Dissolution Testing of Oral Dosage Forms is governed by a range of international and national standards. These ensure that oral dosage forms meet quality and safety standards.

    ---

    Dissolution testing is crucial for ensuring the quality and efficacy of oral dosage forms.

    Why this specific test is needed and required

    Ph. Eur. 2.9.3 Dissolution Testing of Oral Dosage Forms addresses concerns regarding:

  • In vitro-in vivo correlation

  • Quality control and assurance

  • Regulatory compliance

    • Business and Technical Reasons for Conducting Ph. Eur. 2.9.3 Dissolution Testing

    Dissolution testing is necessary to ensure that oral dosage forms meet quality standards, including:

  • Efficacy and safety

  • Stability and compatibility

  • Bioavailability and bioequivalence

    • Consequences of not performing this test

    Failing to conduct dissolution testing can lead to:

  • Ineffective or inadequate product performance

  • Regulatory non-compliance and potential penalties

  • Reputational damage and customer dissatisfaction

    • Industries and Sectors that Require Ph. Eur. 2.9.3 Dissolution Testing

    This laboratory testing service is essential for various industries, including:

  • Pharmaceutical manufacturers

  • Cosmetic companies

  • Food and beverage industry

    • Risk Factors and Safety Implications

    Ph. Eur. 2.9.3 Dissolution Testing of Oral Dosage Forms minimizes the risk of product failure by ensuring:

  • Quality and efficacy

  • Regulatory compliance

  • Customer satisfaction

    • ---

    Conducting Ph. Eur. 2.9.3 Dissolution Testing of Oral Dosage Forms involves a series of steps and procedures.

    Step-by-Step Explanation of the Test

    1. Sample preparation

    2. Apparatus assembly and calibration

    3. Test conditions (temperature, agitation speed, dissolution medium)

    4. Data collection and analysis

    Testing Equipment and Instruments Used

  • Dissolution apparatus (e.g., USP II or rotating basket)

  • Temperature control systems (e.g., water baths or temperature controllers)

  • Agitation systems (e.g., stirrers or agitators)

    • Dissolution Media and Apparatus Selection

    Ph. Eur. 2.9.3 specifies the use of:

  • Purified water

  • Simulated gastric fluid (SGF) or simulated intestinal fluid (SIF)

  • Rotation speed and time

    • Data Collection and Analysis

    Results are obtained using various methods, including:

  • Spectrophotometry (e.g., UV-Vis)

  • Chromatography (e.g., HPLC)

    • ---

    Ph. Eur. 2.9.3 Dissolution Testing of Oral Dosage Forms Service by Eurolab

    At Eurolab, our experienced team provides high-quality Ph. Eur. 2.9.3 Dissolution Testing of Oral Dosage Forms services, ensuring compliance with the latest regulations and standards.

    Our Services Include:

  • Sample preparation

  • Apparatus assembly and calibration

  • Test conditions (temperature, agitation speed, dissolution medium)

  • Data collection and analysis

    • We ensure that our clients receive accurate, reliable results on time, every time.

    ---

    Please note that this is a summary of the comprehensive guide. I will make sure to provide the complete version if you need it.

    Need help or have a question?
    Contact us for prompt assistance and solutions.

    CONTACT US +902127020000

    Latest News

    View all

    Eurolab Successfully Renews ISO 17025 Accreditation

    Read More

    Expanded Cosmetic Safety Testing Portfolio Now Available at Eurolab

    Read More

    Eurolab Launches Technical Training Series for Industry Professionals

    Read More

    JOIN US
    Want to make a difference?

    Careers