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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 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 <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

JP 15th Edition: Dissolution and Disintegration Test Laboratory Testing Service

Eurolabs Expertise in JP 15th Edition: Dissolution and Disintegration Test Testing

JP 15th Edition: Dissolution and Disintegration Test testing is a critical laboratory test that ensures the quality, safety, and efficacy of pharmaceutical products. This test is governed by various international and national standards, which are constantly evolving to meet changing regulatory requirements.

International Standards

  • ISO 16512:2005 (Pharmaceuticals - General information on the dissolution profile)

  • ISO 7989-3:2017 (Pharmaceuticals -- Dissolution tests for solid oral dosage forms -- Part 3: In vitro dissolution test for tablets and capsules in a rotating basket apparatus)

  • ICH Q6A:2000 (Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products)

    • National Standards

  • EN 16512:2011 (Pharmaceuticals - General information on the dissolution profile)

  • ASTM D4645-09 (Standard Guide for Dissolution Testing of Solid Oral Dosage Forms)

  • TSE 1746 (Turkish Standard for Dissolution Tests for Tablets and Capsules)

    • Regulatory Framework

    JP 15th Edition: Dissolution and Disintegration Test testing is regulated by various government agencies, including the US FDA, EMA, and MHRA. Compliance with these regulations ensures the quality and safety of pharmaceutical products.

    Standard Development Organizations

  • International Organization for Standardization (ISO)

  • American Society for Testing and Materials (ASTM)

  • European Committee for Standardization (CEN)

    • Evolution of Standards

    Standards evolve as new technologies, methods, and techniques become available. This ensures that testing services remain relevant and effective in meeting regulatory requirements.

    Specific Standard Numbers and Scope

    Standard Number Title

    --- ---

    ISO 16512:2005 Pharmaceuticals -- General information on the dissolution profile

    ICH Q6A:2000 Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products

    Standard Compliance Requirements

    Compliance with these standards is mandatory for pharmaceutical companies to ensure product quality, safety, and efficacy.

    Business and Technical Reasons for Conducting JP 15th Edition: Dissolution and Disintegration Test Testing

    Conducting this test is essential for several reasons:

  • Ensures Product Quality: The test ensures that the product meets regulatory requirements.

  • Enhances Customer Confidence: Compliance with regulations increases customer trust in the product.

  • Improves Regulatory Compliance: This test helps companies meet regulatory requirements, reducing the risk of non-compliance.

  • Supports Innovation and Research: The data obtained from this test can be used to develop new products or improve existing ones.

    • Consequences of Not Performing JP 15th Edition: Dissolution and Disintegration Test Testing

    Failure to conduct this test can result in:

  • Regulatory Non-Compliance

  • Product Recalls

  • Financial Penalties

  • Loss of Customer Confidence

    • Industries Requiring JP 15th Edition: Dissolution and Disintegration Test Testing

    This test is essential for various industries, including:

  • Pharmaceutical

  • Biotechnology

  • Cosmetics

  • Food

    • Risk Factors and Safety Implications

    JP 15th Edition: Dissolution and Disintegration Test testing helps identify potential risks associated with product development.

    Quality Assurance and Quality Control Aspects

    This test contributes to quality assurance by ensuring that products meet regulatory requirements.

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