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usp-2051-dissolution-testing-for-ion-exchange-resin-based-formulations
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 <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 <2051> Dissolution Testing for Ion Exchange Resin-Based Formulations Laboratory Testing Service

Provided by Eurolab: Ensuring Quality and Compliance

Standard-Related Information

USP <2051> Dissolution Testing for Ion Exchange Resin-Based Formulations is a laboratory testing service that ensures the quality and compliance of ion exchange resin-based formulations with regulatory requirements. This article will provide comprehensive information about the relevant standards, legal and regulatory framework, standard development organizations, and international and national standards.

International Standards

  • ISO 6978:2010, Ion Exchange Resins - Determination of Chloride Content

  • ISO 6979:2005, Ion exchange resins - Determination of sodium content

  • ASTM D974-08, Standard Test Methods for Ion-Exchange Capacity of Water and Wastewater

    • National Standards

  • USP <2051>, Dissolution Testing for Ion Exchange Resin-Based Formulations

  • EN 15954-1:2010, Ion exchange resins - Determination of chloride content

  • TSE (Turkish Standard) 1623:2012, Ion exchange resins - Determination of sodium content

    • 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 through a continuous process of development, review, and revision. This ensures that standards remain relevant and effective in supporting quality and compliance.

    Standard Numbers and Scope

  • USP <2051>: Dissolution Testing for Ion Exchange Resin-Based Formulations

    • Scope: This standard describes the dissolution testing method for ion exchange resin-based formulations.

    Purpose: To ensure the quality and compliance of ion exchange resin-based formulations with regulatory requirements.

  • ISO 6978:2010: Determination of Chloride Content

    • Scope: This standard specifies a method for determining chloride content in ion exchange resins.

    Purpose: To ensure accurate measurement of chloride content.

    Compliance Requirements

    Regulatory compliance is essential to ensure that products meet the required standards. Compliance requirements vary by industry and region, but generally involve:

  • Adhering to relevant national and international standards

  • Ensuring product quality and safety

  • Maintaining documentation and records

    • Standard-Related Industries

    Ion exchange resin-based formulations are used in various industries, including:

  • Water treatment

  • Chemical processing

  • Food and beverage

  • Pharmaceutical manufacturing

    • Consequences of Non-Compliance

    Non-compliance with regulatory requirements can result in:

  • Product recalls

  • Reputational damage

  • Financial losses

  • Safety risks

    • Why USP <2051> Dissolution Testing is Required

    USP <2051> dissolution testing is necessary to ensure the quality and compliance of ion exchange resin-based formulations. This test is required because:

  • Ion exchange resins can affect water quality and safety

  • Inaccurate measurement of chloride content can impact product performance

  • Regulatory compliance ensures product safety and reliability

    • Standard Requirements and Needs

    Ion exchange resin-based formulations require testing to ensure their quality and compliance with regulatory requirements. The main reasons for conducting USP <2051> dissolution testing include:

  • Ensuring product safety and reliability

  • Maintaining regulatory compliance

  • Meeting industry-specific standards and regulations

  • Reducing the risk of product recalls and reputational damage

    • Test Conditions and Methodology

    The test conditions and methodology for USP <2051> dissolution testing are as follows:

  • Equipment: dissolution apparatus, pH meter, conductivity meter

  • Sample preparation: ion exchange resin-based formulation, distilled water

  • Testing parameters: temperature, pH, conductivity

  • Measurement and analysis methods: spectrophotometry, chromatography

  • Calibration and validation procedures: calibration of equipment, validation of test results

    • Test Reporting and Documentation

    The test report for USP <2051> dissolution testing includes:

  • Sample identification and preparation details

  • Test conditions and methodology

  • Results and data analysis

  • Conclusion and recommendations

    • Why This Test Should Be Performed

    Performing USP <2051> dissolution testing has numerous benefits, including:

  • Ensuring product safety and reliability

  • Maintaining regulatory compliance

  • Meeting industry-specific standards and regulations

  • Reducing the risk of product recalls and reputational damage

  • Improving quality assurance and control

    • Why Eurolab Should Provide This Service

    Eurolab is an experienced laboratory testing service provider that offers USP <2051> dissolution testing. The benefits of choosing Eurolab include:

  • Expertise and experience in ion exchange resin-based formulations testing

  • State-of-the-art equipment and facilities

  • Qualified and certified personnel

  • International recognition and partnerships

  • Quality management systems and procedures

    • Conclusion

    USP <2051> dissolution testing is essential for ensuring the quality and compliance of ion exchange resin-based formulations. Eurolabs expertise and experience make it an ideal laboratory testing service provider for this test. By choosing Eurolab, customers can ensure that their products meet regulatory requirements and are safe and reliable.

    References

  • USP <2051>, Dissolution Testing for Ion Exchange Resin-Based Formulations

  • ISO 6978:2010, Ion Exchange Resins - Determination of Chloride Content

  • ASTM D974-08, Standard Test Methods for Ion-Exchange Capacity of Water and Wastewater

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