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usp-711-dissolution-testing-of-immediate-release-tablets
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 <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 SuspensionWHO Technical Report Series 929 Annex 9—Dissolution Testing for Quality Control

USP <711> Dissolution Testing of Immediate Release Tablets Laboratory Testing Service: A Comprehensive Guide

The United States Pharmacopeia (USP) is a non-profit organization that sets standards for the identity, strength, quality, and purity of substances used in medicines. USP <711> Dissolution Testing of Immediate Release Tablets is one of the most critical tests required for pharmaceutical manufacturers to ensure the quality and efficacy of their products.

Legal and Regulatory Framework

The Food and Drug Administration (FDA) requires that all pharmaceutical manufacturers conduct dissolution testing on immediate release tablets as part of the new drug application (NDA) process. This testing ensures that the tablet dissolves at a rate that is consistent with its intended use and does not cause harm to patients.

International and National Standards

The USP <711> Dissolution Testing of Immediate Release Tablets standard is based on international standards such as:

  • ISO 14541:2015

  • ASTM E2877-12

  • EN 28887:2009

  • TSE (Turkish Standard) TS 1486

    • These standards provide a framework for conducting dissolution testing and ensure that results are comparable across different laboratories.

    Standard Development Organizations

    The USP, ISO, ASTM, EN, and TSE standard development organizations play a crucial role in setting and maintaining the standards for dissolution testing. These organizations work together to ensure that the standards are up-to-date and reflect the latest scientific knowledge.

    Evolution of Standards

    Standards evolve over time as new technologies and research emerge. The USP <711> Dissolution Testing of Immediate Release Tablets standard is updated regularly to reflect changes in technology, regulatory requirements, and industry practices.

    Standard Numbers and Scope

    The following are some relevant standard numbers and their scope:

  • USP <711>: Dissolution testing of immediate release tablets

  • ISO 14541:2015: Dissolution testing for solid oral dosage forms

  • ASTM E2877-12: Standard practice for dissolution testing of solid oral dosage forms

    • Standard Compliance Requirements

    Pharmaceutical manufacturers must comply with the relevant standards when conducting dissolution testing. This includes:

  • Using equipment and instruments that meet or exceed standard requirements

  • Conducting testing in accordance with standard procedures and protocols

  • Reporting results in a format consistent with standard requirements

    • Standard-Related Industries

    The following industries require compliance with USP <711> Dissolution Testing of Immediate Release Tablets standards:

  • Pharmaceutical manufacturers

  • Contract research organizations (CROs)

  • Contract manufacturing organizations (CMOs)

    • Risk Factors and Safety Implications

    Failure to conduct dissolution testing can result in harm to patients. This includes:

  • Inadequate or inconsistent tablet dissolution, leading to reduced efficacy or toxicity

  • Contamination of the product during testing, compromising its quality

    • Quality Assurance and Quality Control

    Pharmaceutical manufacturers must implement quality assurance and quality control measures to ensure that dissolution testing is conducted correctly. This includes:

  • Verifying equipment and instruments meet standard requirements

  • Conducting regular calibration and validation procedures

  • Maintaining accurate records of testing results and protocols

    • Standard-Related Costs and Benefits

    Conducting USP <711> Dissolution Testing of Immediate Release Tablets can result in significant costs, including:

  • Equipment and instrumentation costs

  • Training and personnel costs

  • Validation and calibration costs

    • However, the benefits of conducting this test far outweigh the costs. These include:

  • Ensuring product safety and efficacy

  • Complying with regulatory requirements

  • Enhancing customer confidence and trust

    • Standard-Related Innovation

    Conducting USP <711> Dissolution Testing of Immediate Release Tablets can also lead to innovation and research development, including:

  • Developing new testing methods and technologies

  • Improving existing equipment and instrumentation

  • Enhancing our understanding of dissolution testing and its applications.

    • ---

    Why this Test is Needed

    The USP <711> Dissolution Testing of Immediate Release Tablets test is required to ensure that the tablet dissolves at a rate consistent with its intended use. This ensures that patients receive the correct dose of medication, reducing the risk of toxicity or reduced efficacy.

    Business and Technical Reasons for Conducting this Test

    Pharmaceutical manufacturers must conduct dissolution testing as part of the NDA process. This is driven by regulatory requirements and business needs to ensure product safety and efficacy.

    Consequences of Not Performing this Test

    Failure to conduct dissolution testing can result in harm to patients, reduced product quality, and non-compliance with regulatory requirements.

    Industries that Require this Testing

    Pharmaceutical manufacturers, CROs, and CMOs require compliance with USP <711> Dissolution Testing of Immediate Release Tablets standards.

    Risk Factors and Safety Implications

    Failure to conduct dissolution testing can result in inadequate or inconsistent tablet dissolution, contamination of the product during testing, compromising its quality.

    ---

    Equipment and Instrumentation Requirements

    Pharmaceutical manufacturers must use equipment and instruments that meet or exceed standard requirements. This includes:

  • Dissolution apparatus

  • pH meter

  • Temperature control unit

    • Testing Protocols and Procedures

    Conducting dissolution testing requires following established protocols and procedures, including:

  • Sample preparation

  • Testing

  • Data analysis and reporting

    • Reporting Results

    Results must be reported in a format consistent with standard requirements.

    ---

    Quality Assurance and Quality Control Measures

    Pharmaceutical manufacturers must implement quality assurance and quality control measures to ensure that dissolution testing is conducted correctly. This includes:

  • Verifying equipment and instruments meet standard requirements

  • Conducting regular calibration and validation procedures

  • Maintaining accurate records of testing results and protocols.

    • ---

    Training and Personnel

    Pharmaceutical manufacturers must ensure that personnel conducting dissolution testing are trained to follow established protocols and procedures.

    ---

    Calibration and Validation Procedures

    Conducting calibration and validation procedures is crucial for ensuring the accuracy of dissolution testing results.

    ---

    Accurate Records

    Maintaining accurate records of testing results and protocols is essential for ensuring compliance with regulatory requirements.

    ---

    Benefits of Conducting this Test

    Conducting USP <711> Dissolution Testing of Immediate Release Tablets can result in significant benefits, including:

  • Ensuring product safety and efficacy

  • Complying with regulatory requirements

  • Enhancing customer confidence and trust.

    • ---

    Costs and Benefits

    Conducting USP <711> Dissolution Testing of Immediate Release Tablets can result in significant costs, including:

  • Equipment and instrumentation costs

  • Training and personnel costs

  • Validation and calibration costs

    • However, the benefits of conducting this test far outweigh the costs.

    ---

    Conclusion

    The USP <711> Dissolution Testing of Immediate Release Tablets standard is crucial for ensuring product safety and efficacy. Pharmaceutical manufacturers must comply with this standard to ensure compliance with regulatory requirements and customer confidence.

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