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usp-1004-disintegration-testing-of-vaginal-tablets
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 <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

USP <1004> Disintegration Testing of Vaginal Tablets: Eurolabs Laboratory Testing Service

The United States Pharmacopeia (USP) is a non-profit organization that establishes standards for the quality, safety, and efficacy of pharmaceuticals. USP <1004> Disintegration Testing of Vaginal Tablets is one such standard that outlines the requirements for disintegration testing of vaginal tablets.

1.1 Legal and Regulatory Framework

The legal and regulatory framework surrounding USP <1004> Disintegration Testing of Vaginal Tablets is governed by various national and international standards, including:

  • USP <1004>

  • ISO 13485:2016

  • ASTM E1820-11

  • EN 13721:2009

  • TSE (Turkish Standards Institution) TS 1231:2018

    • 1.2 Standard Development Organizations

    Standard development organizations such as the International Organization for Standardization (ISO), American Society for Testing and Materials (ASTM), and European Committee for Standardization (CEN) play a crucial role in developing and updating standards.

    1.3 Evolution of Standards

    Standards evolve over time to reflect new technologies, scientific advancements, and changing regulatory requirements.

    1.4 Specific Standard Numbers and Scope

    The following are some specific standard numbers and their scope:

  • USP <1004>: Disintegration testing of vaginal tablets

  • ISO 13485:2016: Medical devices - Quality management systems - Requirements for regulatory purposes

  • ASTM E1820-11: Standard Test Method for Disintegration of Solid Oral Dosage Forms

  • EN 13721:2009: Medical devices - Sterilization of medical instruments and equipment by dry heat (130C)

  • TSE TS 1231:2018: Pharmacopoeial standards for vaginal tablets

    • 1.5 Industry-Specific Compliance Requirements

    Compliance with these standards is mandatory for various industries, including:

  • Pharmaceutical manufacturers

  • Medical device manufacturers

  • Contract research organizations (CROs)

  • Contract manufacturing organizations (CMOs)

    • 2.1 Why This Test is Needed and Required

    Disintegration testing of vaginal tablets is essential to ensure the safety, efficacy, and quality of these products.

    2.2 Business and Technical Reasons for Conducting USP <1004> Disintegration Testing of Vaginal Tablets

    The test provides valuable information on the disintegration properties of vaginal tablets, which affects their performance in vivo.

    2.3 Consequences of Not Performing This Test

    Failure to conduct this test can lead to suboptimal product performance, regulatory non-compliance, and potential harm to patients.

    2.4 Industries and Sectors That Require This Testing

    The following industries and sectors require disintegration testing of vaginal tablets:

  • Pharmaceutical industry

  • Medical device industry

  • Contract research organizations (CROs)

  • Contract manufacturing organizations (CMOs)

    • 2.5 Risk Factors and Safety Implications

    Incorrect or inadequate disintegration properties can lead to adverse events, product recalls, and reputational damage.

    3.1 Detailed Step-by-Step Explanation of How the Test is Conducted

    The test involves the following steps:

  • Sample preparation

  • Testing equipment calibration

  • Disintegration testing

  • Data collection and analysis

    • 3.2 Testing Equipment and Instruments Used

    The following instruments are used for disintegration testing:

  • Disintegration tester

  • Water bath

  • Thermometer

  • Stopwatch

    • 3.3 Testing Environment Requirements

    The testing environment must meet the following conditions:

  • Temperature: 37C 0.5C

  • Humidity: 55 5

  • Pressure: 1 atm 0.05 atm

    • 4.1 How Test Results are Documented and Reported

    Test results are documented in a clear, concise manner using standardized report templates.

    4.2 Report Format and Structure

    Reports include the following information:

  • Sample identification

  • Testing conditions

  • Disintegration time

  • Data analysis

    • 4.3 Interpretation of Test Results

    Results are interpreted based on established criteria to ensure compliance with USP <1004> standards.

    5.1 Benefits and Advantages

    This test provides a range of benefits, including:

  • Ensuring product safety and efficacy

  • Enhancing regulatory compliance

  • Improving product performance

  • Mitigating risk factors

  • Building customer trust and confidence

    • Eurolab offers comprehensive testing services for disintegration of vaginal tablets, including:

  • Experienced staff with expertise in pharmaceutical testing

  • State-of-the-art equipment and facilities

  • High-quality test reports and documentation

  • Efficient turnaround times

  • Competitive pricing

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

    CONTACT US +902127020000

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