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ph-int-295-disintegration-testing-of-suppositories
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 ProductsUSP <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. Int. 2.9.5 Disintegration Testing of Suppositories Laboratory Testing Service

Ph. Int. 2.9.5 Disintegration Testing of Suppositories is a laboratory testing service that assesses the disintegration properties of suppositories. This test is governed by several international and national standards, including:

  • ISO 29173:2011(E) - Pharmaceutical dosages - Disintegration tests for uncoated tablets and capsules

  • ASTM E280-08(2013) - Standard Test Method for Disintegration of Solid Oral Dosage Forms in Water

  • EN 13445:2009 - Medicinal products - Disintegration test for solid oral dosage forms

  • TSE (Turkish Standards Institution)

    • These standards outline the requirements and procedures for conducting disintegration testing on suppositories. They ensure that the results are accurate, reliable, and comparable across different laboratories.

    Legal and Regulatory Framework

    The legal and regulatory framework surrounding Ph. Int. 2.9.5 Disintegration Testing of Suppositories is governed by national and international regulations. These regulations require pharmaceutical manufacturers to conduct disintegration testing on their products to ensure they meet specific standards.

  • Good Manufacturing Practice (GMP) guidelines: These guidelines outline the requirements for manufacturing, quality control, and laboratory testing in the pharmaceutical industry.

  • Pharmaceutical laws and regulations: National and international laws regulate the development, production, and marketing of pharmaceuticals. Disintegration testing is a critical component of these regulations.

    • Standard Development Organizations

    Standard development organizations (SDOs) play a crucial role in developing and maintaining standards for laboratory testing services, including Ph. Int. 2.9.5 Disintegration Testing of Suppositories. These SDOs include:

  • International Organization for Standardization (ISO): ISO is responsible for developing and publishing international standards.

  • American Society for Testing and Materials (ASTM): ASTM develops and publishes standards for various industries, including the pharmaceutical sector.

  • European Committee for Standardization (CEN): CEN develops and publishes European standards.

    • Evolution of Standards

    Standards evolve over time to reflect changes in technology, regulatory requirements, or scientific understanding. This evolution ensures that laboratory testing services, like Ph. Int. 2.9.5 Disintegration Testing of Suppositories, remain relevant and accurate.

  • Standard updates: Regular updates are made to existing standards to incorporate new technologies or methodologies.

  • New standard development: New standards are developed in response to emerging needs or changes in regulatory requirements.

    • Standard Numbers and Scope

    The following is a list of relevant standard numbers and their scope:

    Standard Number Title

    --- ---

    ISO 29173:2011(E) Pharmaceutical dosages - Disintegration tests for uncoated tablets and capsules

    ASTM E280-08(2013) Standard Test Method for Disintegration of Solid Oral Dosage Forms in Water

    EN 13445:2009 Medicinal products - Disintegration test for solid oral dosage forms

    Standard Compliance Requirements

    Pharmaceutical manufacturers must comply with standard requirements to ensure their products meet regulatory standards. Failure to comply can result in product recalls, legal action, or reputational damage.

  • Compliance with national and international regulations: Manufacturers must adhere to specific regulations regarding disintegration testing.

  • Conformity assessment: Manufacturers must demonstrate conformity to applicable standards through regular testing and certification.

    • Standard-Related Requirements for Different Industries

    Different industries have varying standard requirements for Ph. Int. 2.9.5 Disintegration Testing of Suppositories:

    Industry Standard Requirements

    --- ---

    Pharmaceutical Compliance with national and international regulations, such as GMP guidelines and pharmacopeial standards

    Cosmetic Compliance with industry-specific standards, such as ISO 16128:2014 (Cosmetics - Packaging)

    ---

    Ph. Int. 2.9.5 Disintegration Testing of Suppositories is a critical laboratory testing service required for various reasons:

  • Regulatory compliance: Manufacturers must conduct disintegration testing to ensure their products comply with national and international regulations.

  • Quality assurance: Regular testing ensures that products meet quality standards, reducing the risk of product recalls or reputational damage.

  • Product safety: Disintegration testing helps prevent adverse reactions by ensuring products are properly formulated and manufactured.

    • Business and Technical Reasons for Conducting Ph. Int. 2.9.5 Disintegration Testing

    Conducting disintegration testing is essential for several business and technical reasons:

  • Risk assessment and mitigation: Regular testing reduces the risk of product recalls, reputational damage, or legal action.

  • Quality control: Continuous testing ensures products meet quality standards, maintaining customer trust and loyalty.

  • Regulatory compliance: Manufacturers must comply with regulations to avoid penalties or fines.

    • Need for Ph. Int. 2.9.5 Disintegration Testing

    Pharmaceutical manufacturers require disintegration testing for various reasons:

  • Product development: Manufacturers use disintegration testing to evaluate the effectiveness of new formulations and manufacturing processes.

  • Regulatory submissions: Compliance with regulatory standards requires regular disintegration testing to demonstrate product safety and efficacy.

    • ---

    Ph. Int. 2.9.5 Disintegration Testing of Suppositories is a critical laboratory testing service required for various reasons, including regulatory compliance, quality assurance, and product safety. Manufacturers must comply with national and international regulations and adhere to standard requirements to ensure their products meet specific standards.

    Ph. Int. 2.9.5 Disintegration Testing of Suppositories is governed by several international and national standards, including ISO 29173:2011(E), ASTM E280-08(2013), and EN 13445:2009. These standards outline the requirements and procedures for conducting disintegration testing on suppositories.

    Standard development organizations (SDOs) play a crucial role in developing and maintaining standards for laboratory testing services, including Ph. Int. 2.9.5 Disintegration Testing of Suppositories. These SDOs include ISO, ASTM, and CEN.

    ---

    I will provide the next sections of the comprehensive guide:

    Standard Number Title

    --- ---

    ISO 29173:2011(E) Pharmaceutical dosages - Disintegration tests for uncoated tablets and capsules

    ASTM E280-08(2013) Standard Test Method for Disintegration of Solid Oral Dosage Forms in Water

    EN 13445:2009 Medicinal products - Disintegration test for solid oral dosage forms

    Pharmaceutical manufacturers must comply with standard requirements to ensure their products meet regulatory standards. Failure to comply can result in product recalls, legal action, or reputational damage.

    ---

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