EUROLAB
ph-eur-2939-dissolution-of-patches-and-implants
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. 2.9.4 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. 2.9.39 Dissolution of Patches and Implants Testing Service Provided by Eurolab

Standard-Related Information

Pharmaceutical testing services play a vital role in ensuring the quality, safety, and efficacy of pharmaceutical products. One such critical test is the dissolution test for patches and implants, governed by Ph. Eur. 2.9.39. This standard outlines the requirements for conducting dissolution tests on transdermal delivery systems (TDS) and implantable drug delivery systems (IDDS). In this article, we will delve into the world of standards related to Ph. Eur. 2.9.39 Dissolution of Patches and Implants testing.

International Standards

The European Pharmacopoeia (Ph. Eur.) is a collection of standards for pharmaceutical products and materials published by the Council of Europe. Ph. Eur. 2.9.39 is one such standard that provides guidelines for dissolution testing of patches and implants. The standard is developed through a collaborative effort between experts from various countries, industries, and regulatory bodies.

National Standards

In addition to international standards, national standards also play a significant role in governing Ph. Eur. 2.9.39 Dissolution of Patches and Implants testing. Each country may have its own national standards or adapt the international standards to suit their specific needs.

Standard Development Organizations

Standard development organizations (SDOs) are instrumental in creating, revising, and maintaining standards. The most prominent SDOs involved in pharmaceutical standardization include:

  • International Organization for Standardization (ISO)

  • American Society for Testing and Materials (ASTM)

  • European Committee for Standardization (CEN)

  • Turkish Standards Institution (TSE)

    • Standard Evolution

    Standards evolve as new scientific knowledge, technologies, and regulatory requirements emerge. The revision process involves a thorough review of the existing standard, incorporating feedback from experts, industries, and regulatory bodies.

    Ph. Eur. 2.9.39 Scope and Requirements

    Ph. Eur. 2.9.39 outlines the requirements for dissolution testing of patches and implants. The standard specifies:

  • Test apparatus

  • Test conditions (temperature, medium, etc.)

  • Sampling procedures

  • Analytical methods (e.g., HPLC, UV spectroscopy)

  • Acceptance criteria

    • Compliance Requirements

    Pharmaceutical manufacturers must comply with Ph. Eur. 2.9.39 and national standards to ensure the quality, safety, and efficacy of their products.

    Standard-Related Consequences

    Failure to comply with Ph. Eur. 2.9.39 may lead to:

  • Regulatory non-compliance

  • Product recall or rejection

  • Loss of market share and reputation

    • Conclusion

    Ph. Eur. 2.9.39 Dissolution of Patches and Implants testing is a critical component in ensuring the quality, safety, and efficacy of pharmaceutical products. Compliance with international and national standards is essential for manufacturers to maintain their market position and regulatory approval.

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    Standard Requirements and Needs

    Ph. Eur. 2.9.39 Dissolution of Patches and Implants testing is necessary due to several reasons:

  • Business and Technical Reasons: Pharmaceutical manufacturers need to ensure that their products meet the required quality, safety, and efficacy standards.

  • Consequences of Not Performing the Test: Failure to comply with Ph. Eur. 2.9.39 may lead to regulatory non-compliance, product recall or rejection, loss of market share, and reputation damage.

    • Industries and Sectors

    Ph. Eur. 2.9.39 Dissolution of Patches and Implants testing is relevant to various industries, including:

  • Pharmaceutical manufacturing

  • Biotechnology

  • Medical devices

    • Risk Factors and Safety Implications

    Non-compliance with Ph. Eur. 2.9.39 may lead to:

  • Patient safety risks (e.g., inadequate dissolution profiles)

  • Regulatory non-compliance

  • Product recall or rejection

    • Quality Assurance and Quality Control Aspects

    Pharmaceutical manufacturers must implement quality assurance and control measures to ensure compliance with Ph. Eur. 2.9.39.

    Conclusion

    Ph. Eur. 2.9.39 Dissolution of Patches and Implants testing is essential for pharmaceutical manufacturers to ensure the quality, safety, and efficacy of their products.

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    Test Conditions and Methodology

    Conducting Ph. Eur. 2.9.39 Dissolution of Patches and Implants testing involves several steps:

    1. Apparatus Preparation: The test apparatus must be properly prepared, calibrated, and validated.

    2. Sample Preparation: The sample must be accurately weighed, prepared, and placed in the dissolution vessel.

    3. Test Conditions: The test is conducted under specified conditions (temperature, medium, etc.).

    4. Sampling Procedures: Samples are taken at regular intervals for analysis.

    5. Analytical Methods: Analytical methods such as HPLC or UV spectroscopy are used to determine the dissolved drug concentration.

    Acceptance Criteria

    Pharmaceutical manufacturers must meet the specified acceptance criteria outlined in Ph. Eur. 2.9.39.

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    Conclusion

    Ph. Eur. 2.9.39 Dissolution of Patches and Implants testing is a critical component in ensuring the quality, safety, and efficacy of pharmaceutical products. Compliance with international and national standards is essential for manufacturers to maintain their market position and regulatory approval.

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    Eurolabs Expertise

    At Eurolab, we have extensive experience in Ph. Eur. 2.9.39 Dissolution of Patches and Implants testing. Our team of experts will ensure that your products meet the required standards, providing you with peace of mind and compliance with regulatory requirements.

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    Why Choose Eurolab?

    Eurolab offers:

  • Expertise: Our team has extensive experience in Ph. Eur. 2.9.39 Dissolution of Patches and Implants testing.

  • Compliance: We ensure that your products meet the required standards, ensuring regulatory compliance.

  • Quality: Our facilities are equipped with state-of-the-art equipment and technologies to ensure accurate results.

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    Conclusion

    Ph. Eur. 2.9.39 Dissolution of Patches and Implants testing is a critical component in ensuring the quality, safety, and efficacy of pharmaceutical products. Compliance with international and national standards is essential for manufacturers to maintain their market position and regulatory approval. At Eurolab, we are committed to providing you with expert services that meet your requirements.

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