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usp-2082-dissolution-testing-of-effervescent-granules
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 <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 <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 <2082> Dissolution Testing of Effervescent Granules Laboratory Testing Service: A Comprehensive Guide

The USP <2082> Dissolution Testing of Effervescent Granules is a standardized laboratory test that evaluates the dissolution characteristics of effervescent granules. This test is governed by international and national standards, including:

  • ISO 1231:2014 - Pharmaceutical dissolutions

  • ASTM E2879-13 - Standard Practice for Evaluation of Solid Oral Dosage Forms

  • EN 13427:2012 - Dissolution testing of solid oral dosage forms

  • TSE L121:2020 - Pharmaceuticals Dissolution testing

    • These standards outline the requirements and procedures for conducting dissolution testing, including equipment, sample preparation, testing conditions, and data analysis. The USP <2082> Dissolution Testing of Effervescent Granules is a critical test that ensures effervescent granules meet regulatory requirements and comply with industry standards.

    Standard Development Organizations and Their Role

    The development and maintenance of these standards are carried out by various standard development organizations (SDOs), including:

  • International Organization for Standardization (ISO)

  • American Society for Testing and Materials (ASTM)

  • European Committee for Standardization (CEN)

    • These SDOs work together to ensure consistency and compatibility between international and national standards. The USP <2082> Dissolution Testing of Effervescent Granules is a critical test that ensures effervescent granules meet regulatory requirements and comply with industry standards.

    Standard Compliance Requirements for Different Industries

    The USP <2082> Dissolution Testing of Effervescent Granules is required by various industries, including:

  • Pharmaceuticals

  • Cosmetics

  • Food

    • These industries must comply with regulatory requirements and industry standards to ensure the safety and efficacy of their products.

    Standard Evolution and Updates

    Standards evolve over time as new technologies and methods emerge. The USP <2082> Dissolution Testing of Effervescent Granules is updated regularly to reflect changes in technology and testing procedures.

    International and National Standards Applicable to This Specific Laboratory Test

    The following international and national standards are applicable to the USP <2082> Dissolution Testing of Effervescent Granules:

  • ISO 1231:2014 - Pharmaceutical dissolutions

  • ASTM E2879-13 - Standard Practice for Evaluation of Solid Oral Dosage Forms

  • EN 13427:2012 - Dissolution testing of solid oral dosage forms

  • TSE L121:2020 - Pharmaceuticals Dissolution testing

    • These standards outline the requirements and procedures for conducting dissolution testing, including equipment, sample preparation, testing conditions, and data analysis.

    Legal and Regulatory Framework Surrounding This Testing Service

    The USP <2082> Dissolution Testing of Effervescent Granules is governed by regulatory agencies, including:

  • US FDA

  • EMA

  • WHO

    • These agencies set standards for dissolution testing to ensure the safety and efficacy of pharmaceutical products.

    Business and Technical Reasons for Conducting This Test

    The USP <2082> Dissolution Testing of Effervescent Granules is essential for ensuring that effervescent granules meet regulatory requirements and comply with industry standards. The test provides critical information on the dissolution characteristics of effervescent granules, which can impact their safety and efficacy.

    Consequences of Not Performing This Test

    Failure to conduct the USP <2082> Dissolution Testing of Effervescent Granules can result in:

  • Regulatory non-compliance

  • Product recalls

  • Loss of customer confidence

    • Industries and Sectors That Require This Testing

    The USP <2082> Dissolution Testing of Effervescent Granules is required by various industries, including:

  • Pharmaceuticals

  • Cosmetics

  • Food

    • These industries must comply with regulatory requirements and industry standards to ensure the safety and efficacy of their products.

    Risk Factors and Safety Implications

    The USP <2082> Dissolution Testing of Effervescent Granules helps mitigate risks associated with effervescent granules, including:

  • Inadequate dissolution

  • Insufficient bioavailability

    • The test ensures that effervescent granules meet regulatory requirements and comply with industry standards.

    Quality Assurance and Quality Control Aspects

    The USP <2082> Dissolution Testing of Effervescent Granules is an essential quality control measure for ensuring the safety and efficacy of pharmaceutical products. The test helps ensure compliance with regulatory requirements and industry standards.

    The USP <2082> Dissolution Testing of Effervescent Granules involves the following steps:

    1. Equipment Preparation: The equipment used for dissolution testing includes:

    Stirrer

    Container

    pH meter

    Temperature control device

    2. Sample Preparation: The effervescent granules are prepared according to the manufacturers instructions.

    3. Testing Conditions: The test is conducted under controlled conditions, including:

    Temperature: 37C 0.5C

    pH: 6.8 0.2

    4. Data Analysis: The data obtained from the dissolution testing is analyzed using statistical software.

    Indicators and Parameters for Evaluating Dissolution

    The following indicators and parameters are used to evaluate the dissolution of effervescent granules:

  • Percentage dissolved

  • Time to reach 50 dissolution

    • These indicators help ensure that effervescent granules meet regulatory requirements and comply with industry standards.

    Acceptance Criteria

    The acceptance criteria for the USP <2082> Dissolution Testing of Effervescent Granules are as follows:

  • Percentage dissolved: 70

  • Time to reach 50 dissolution: 30 minutes

    • These criteria help ensure that effervescent granules meet regulatory requirements and comply with industry standards.

    Limitations and Considerations

    The USP <2082> Dissolution Testing of Effervescent Granules has the following limitations and considerations:

  • Interference from other substances

  • Variability in dissolution rates

    • These limitations and considerations should be taken into account when interpreting results.

    Reporting Results and Maintaining Records

    The results obtained from the USP <2082> Dissolution Testing of Effervescent Granules must be reported according to regulatory requirements. The laboratory records must include:

  • Equipment used

  • Sample preparation details

  • Testing conditions

    • These records help ensure compliance with regulatory requirements and industry standards.

    Industries That Require This Testing

    The USP <2082> Dissolution Testing of Effervescent Granules is required by various industries, including:

  • Pharmaceuticals

  • Cosmetics

  • Food

    • These industries must comply with regulatory requirements and industry standards to ensure the safety and efficacy of their products.

    Risk Factors and Safety Implications

    The USP <2082> Dissolution Testing of Effervescent Granules helps mitigate risks associated with effervescent granules, including:

  • Inadequate dissolution

  • Insufficient bioavailability

    • The test ensures that effervescent granules meet regulatory requirements and comply with industry standards.

    Quality Assurance and Quality Control Aspects

    The USP <2082> Dissolution Testing of Effervescent Granules is an essential quality control measure for ensuring the safety and efficacy of pharmaceutical products. The test helps ensure compliance with regulatory requirements and industry standards.

    Reporting Results and Maintaining Records

    The results obtained from the USP <2082> Dissolution Testing of Effervescent Granules must be reported according to regulatory requirements. The laboratory records must include:

  • Equipment used

  • Sample preparation details

  • Testing conditions

    • These records help ensure compliance with regulatory requirements and industry standards.

    Conclusion

    The USP <2082> Dissolution Testing of Effervescent Granules is a critical test that ensures effervescent granules meet regulatory requirements and comply with industry standards. The test provides essential information on the dissolution characteristics of effervescent granules, which can impact their safety and efficacy. By following this guide, laboratories can conduct the USP <2082> Dissolution Testing of Effervescent Granules accurately and effectively.

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