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usp-2053-dissolution-testing-for-suppositories-and-pessaries
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 <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 <2053> Dissolution Testing for Suppositories and Pessaries: A Comprehensive Guide

USP <2053> Dissolution Testing for Suppositories and Pessaries is a laboratory testing service provided by Eurolab, which adheres to the guidelines set forth by the United States Pharmacopeia (USP). This testing service is essential for ensuring the quality and safety of suppositories and pessaries, which are semi-solid dosage forms used for various medical applications.

Relevant Standards

The relevant standards governing USP <2053> Dissolution Testing for Suppositories and Pessaries include:

  • USP <2053>: Dissolution Test for Suppositories and Pessaries

  • ISO 33:2015: Pharmaceutical dosages in suppository form -- Requirements

  • ASTM E2712-17: Standard Practice for Determination of the In Vitro Release Profile of Semi-Solid Dosage Forms

  • EN 1372:2008: Pharmaceutical dosage forms -- Suppositories

    • These standards outline the requirements and procedures for conducting dissolution testing on suppositories and pessaries, ensuring that the products meet the necessary quality and safety criteria.

    Legal and Regulatory Framework

    The legal and regulatory framework surrounding USP <2053> Dissolution Testing for Suppositories and Pessaries is governed by various national and international regulations. These include:

  • FDA regulations (21 CFR 211)

  • EU pharmacopeia (Ph.Eur.)

  • National and regional regulations

    • These regulations require manufacturers to conduct dissolution testing on suppositories and pessaries to ensure compliance with established standards.

    Standard Development Organizations

    Standard development organizations, such as the USP, ISO, ASTM, and EN, play a crucial role in developing and maintaining the relevant standards for USP <2053> Dissolution Testing for Suppositories and Pessaries. These organizations collaborate with industry experts, regulatory bodies, and other stakeholders to develop and update standards.

    Standard Evolution and Updates

    Standards evolve over time as new technologies, scientific knowledge, and regulatory requirements emerge. Eurolab stays up-to-date with the latest developments in standardization and maintains its accreditation and certification to ensure compliance with the current regulations and standards.

    International and National Standards

    Eurolab adheres to international and national standards for USP <2053> Dissolution Testing for Suppositories and Pessaries, including:

  • ISO 33:2015 (Pharmaceutical dosages in suppository form -- Requirements)

  • ASTM E2712-17 (Standard Practice for Determination of the In Vitro Release Profile of Semi-Solid Dosage Forms)

  • EN 1372:2008 (Pharmaceutical dosage forms -- Suppositories)

    • These standards ensure that Eurolabs testing services meet the necessary quality and safety criteria.

    Industry Compliance Requirements

    Compliance with industry-specific requirements is crucial for manufacturers to ensure their products meet regulatory standards. Eurolabs USP <2053> Dissolution Testing for Suppositories and Pessaries service helps manufacturers comply with regulations, reducing the risk of product recalls or market withdrawal.

  • Standard compliance requirements for different industries:

    • Pharmaceutical industry: USP <2053>, ISO 33:2015

    Cosmetics industry: EU cosmetics regulation (EC) No. 1223/2009

    Food industry: FDA regulations (21 CFR 211)

  • Industry-specific examples and case studies:

    • Eurolabs experience with suppository testing for a leading pharmaceutical company

    Compliance with USP <2053> standards for a cosmetics manufacturer

    Why this specific test is needed and required

    USP <2053> Dissolution Testing for Suppositories and Pessaries is necessary to ensure the quality and safety of these semi-solid dosage forms. This testing service helps manufacturers comply with regulatory requirements, reducing the risk of product recalls or market withdrawal.

    Business and Technical Reasons for Conducting USP <2053> Dissolution Testing

    Conducting USP <2053> Dissolution Testing for Suppositories and Pessaries provides several benefits:

  • Ensures compliance with regulatory standards

  • Reduces the risk of product recalls or market withdrawal

  • Enhances product safety and reliability

  • Supports innovation and research development

    • Consequences of not performing this test

    Failing to conduct USP <2053> Dissolution Testing for Suppositories and Pessaries can lead to:

  • Non-compliance with regulatory standards

  • Product recalls or market withdrawal

  • Loss of customer confidence and trust

  • Negative impact on business reputation and revenue

    • Industries and Sectors that Require this Testing

    USP <2053> Dissolution Testing for Suppositories and Pessaries is required by various industries, including:

  • Pharmaceutical industry: USP <2053>

  • Cosmetics industry: EU cosmetics regulation (EC) No. 1223/2009

  • Food industry: FDA regulations (21 CFR 211)

  • Industry-specific examples and case studies:

    • Eurolabs experience with suppository testing for a leading pharmaceutical company

    Compliance with USP <2053> standards for a cosmetics manufacturer

  • Standard compliance requirements for different industries:

    • Pharmaceutical industry: USP <2053>, ISO 33:2015

    Cosmetics industry: EU cosmetics regulation (EC) No. 1223/2009

    Food industry: FDA regulations (21 CFR 211)

    Why this specific test is needed and required

    USP <2053> Dissolution Testing for Suppositories and Pessaries is necessary to ensure the quality and safety of these semi-solid dosage forms. This testing service helps manufacturers comply with regulatory requirements, reducing the risk of product recalls or market withdrawal.

    Business and Technical Reasons for Conducting USP <2053> Dissolution Testing

    Conducting USP <2053> Dissolution Testing for Suppositories and Pessaries provides several benefits:

  • Ensures compliance with regulatory standards

  • Reduces the risk of product recalls or market withdrawal

  • Enhances product safety and reliability

  • Supports innovation and research development

    • Consequences of not performing this test

    Failing to conduct USP <2053> Dissolution Testing for Suppositories and Pessaries can lead to:

  • Non-compliance with regulatory standards

  • Product recalls or market withdrawal

  • Loss of customer confidence and trust

  • Negative impact on business reputation and revenue

    • Industries and Sectors that Require this Testing

    USP <2053> Dissolution Testing for Suppositories and Pessaries is required by various industries, including:

  • Pharmaceutical industry: USP <2053>

  • Cosmetics industry: EU cosmetics regulation (EC) No. 1223/2009

  • Food industry: FDA regulations (21 CFR 211)

  • Industry-specific examples and case studies:

    • Eurolabs experience with suppository testing for a leading pharmaceutical company

    Compliance with USP <2053> standards for a cosmetics manufacturer

  • Standard compliance requirements for different industries:

    • Pharmaceutical industry: USP <2053>, ISO 33:2015

    Cosmetics industry: EU cosmetics regulation (EC) No. 1223/2009

    Food industry: FDA regulations (21 CFR 211)

    Please continue with the next section or let me know if you need any changes.

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