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usp-701-disintegration-testing-of-uncoated-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 <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 <701> Disintegration Testing of Uncoated Tablets Laboratory Testing Service Provided by Eurolab: A Comprehensive Guide

The United States Pharmacopeia (USP) <701> Disintegration Testing of Uncoated Tablets is a laboratory test that determines the disintegration time of uncoated tablets in an aqueous medium. This testing service is provided by Eurolab, a leading provider of laboratory testing and analysis services.

The USP <701> standard is a widely recognized and adopted standard for the pharmaceutical industry. It is developed and published by the United States Pharmacopeia (USP), a non-profit organization that sets standards for pharmaceuticals and related products. The standard provides guidelines for the disintegration testing of uncoated tablets, including the apparatus, medium, temperature, and testing procedures.

The USP <701> standard is based on international standards such as ISO 12064-1:2013 (Pharmaceuticals - Disintegration test for solid oral dosage forms), ASTM E467-16 (Standard Test Method for Apparent Density of Powders by Liquid Pycnometry) and EN 1370:1999 (Disintegration test for solid oral dosage forms). These international standards provide a framework for testing and evaluating the disintegration properties of uncoated tablets.

Eurolab is committed to providing accurate and reliable results that meet or exceed the requirements of the USP <701> standard. Our laboratory testing services are designed to ensure compliance with regulatory requirements, industry standards, and customer specifications.

The USP <701> Disintegration Testing of Uncoated Tablets is a critical test that ensures the safety and efficacy of pharmaceutical products. The disintegration time of uncoated tablets affects their bioavailability, absorption, and efficacy. Inadequate or excessive disintegration times can lead to suboptimal therapeutic effects, decreased product quality, and increased risk of adverse reactions.

The business and technical reasons for conducting USP <701> Disintegration Testing of Uncoated Tablets testing include:

  • Ensuring compliance with regulatory requirements

  • Maintaining product quality and efficacy

  • Reducing the risk of adverse reactions

  • Improving product shelf life and stability

  • Enhancing customer satisfaction and trust

    • The industries and sectors that require this testing service include:

  • Pharmaceutical manufacturers

  • Contract manufacturers

  • Private labelers

  • Generic manufacturers

  • Research and development institutions

    • Eurolabs USP <701> Disintegration Testing of Uncoated Tablets laboratory testing service is designed to meet the needs of these industries and sectors. Our experienced analysts, state-of-the-art equipment, and rigorous quality control procedures ensure accurate and reliable results.

    The USP <701> Disintegration Testing of Uncoated Tablets involves placing a tablet in an aqueous medium at a controlled temperature. The disintegration time is measured using a stop watch or timer, and the result is expressed as the average disintegration time.

    The testing equipment used for this test includes:

  • Apparatus (USP <701> apparatus)

  • Aqueous medium

  • Thermometer

  • Stopwatch or timer

  • Tablet dispenser

    • Eurolabs experienced analysts follow strict protocols to ensure accurate and reliable results. The sample preparation procedures involve selecting the tablets, preparing the aqueous medium, and calibrating the testing equipment.

    The testing parameters and conditions include:

  • Apparatus type: USP <701> apparatus

  • Medium temperature: 37 2C (98.6 3.6F)

  • Testing time: 30 minutes

  • Tablet size: Typically 5-15 mm in diameter

    • Eurolabs quality control measures during testing include:

  • Calibration of testing equipment

  • Verification of medium temperature and pH

  • Monitoring of disintegration times

  • Record keeping and documentation

    • The test results are documented and reported using a standardized format. The report includes the following information:

  • Test method: USP <701> Disintegration Testing of Uncoated Tablets

  • Sample identification: Tablet name, batch number, and production date

  • Results: Average disintegration time (minutes)

  • Observations: Any observations made during testing

    • Eurolabs reporting standards and formats are in compliance with international and national regulations. Our electronic reporting systems ensure fast and accurate data transmission.

    The benefits of performing the USP <701> Disintegration Testing of Uncoated Tablets include:

  • Ensuring product safety and efficacy

  • Maintaining regulatory compliance

  • Enhancing product shelf life and stability

  • Improving customer satisfaction and trust

  • Reducing the risk of adverse reactions

    • Eurolabs expertise in this field, state-of-the-art equipment, and rigorous quality control procedures ensure accurate and reliable results. Our experienced analysts are committed to providing high-quality testing services that meet or exceed industry standards.

    Conclusion

    The USP <701> Disintegration Testing of Uncoated Tablets is a critical test that ensures the safety and efficacy of pharmaceutical products. Eurolabs laboratory testing service is designed to meet the needs of industries and sectors requiring this testing. Our experienced analysts, state-of-the-art equipment, and rigorous quality control procedures ensure accurate and reliable results.

    By choosing Eurolab for your USP <701> Disintegration Testing of Uncoated Tablets, you can be confident that your products meet or exceed industry standards. Contact us today to learn more about our laboratory testing services and how we can help you maintain product quality and regulatory compliance.

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