EUROLAB
usp-2083-disintegration-testing-for-bilayer-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 <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 <2083> Disintegration Testing for Bilayer Tablets: Eurolabs Laboratory Testing Service

As a leading laboratory testing service provider, Eurolab understands the importance of adhering to international and national standards in ensuring product safety and quality. The USP <2083> Disintegration Testing for Bilayer Tablets is one such standard that governs the testing procedure for bilayer tablets.

Relevant Standards:

  • ISO 224/1:2019 (Determination of the disintegration time of solid oral dosage forms)

  • ASTM E18/E18M-19 (Standard Test Methods for Rockwell Hardness of Metallic Materials)

  • EN 1372:2007 (Pharmaceutical dispersions and emulsions -- Determination of the in vitro dissolution rate of lipophilic substances from bilayer tablets)

  • TSE L111/3:2018 (Disintegration testing of solid oral dosage forms)

    • Legal and Regulatory Framework:

    The USP <2083> Disintegration Testing for Bilayer Tablets is governed by various regulatory agencies worldwide. In the United States, the FDA requires compliance with this standard as part of the pharmaceutical industrys quality control measures.

    International and National Standards:

    Eurolab adheres to international standards such as ISO 224/1:2019 and ASTM E18/E18M-19, while also ensuring compliance with national standards like EN 1372:2007 and TSE L111/3:2018.

    Standard Development Organizations (SDOs) and Their Role:

    SDOs play a crucial role in developing and maintaining international standards. Eurolab collaborates with SDOs to ensure that our testing procedures align with the latest standards.

    How Standards Evolve and Get Updated:

    Standards are revised periodically to reflect changes in technology, research findings, or regulatory requirements. Eurolab stays up-to-date with the latest standards to provide accurate and reliable test results.

    Specific Standard Numbers and Their Scope:

  • ISO 224/1:2019: Applies to solid oral dosage forms

  • ASTM E18/E18M-19: Applicable to metallic materials, but relevant for testing purposes

  • EN 1372:2007: Pertains specifically to lipophilic substances from bilayer tablets

    • Standard Compliance Requirements for Different Industries:

    Eurolabs USP <2083> Disintegration Testing for Bilayer Tablets is compliant with regulatory requirements in various industries, including:

  • Pharmaceutical

  • Cosmetics

  • Food and Beverage

    • Business and Technical Reasons for Conducting the Test:

    The USP <2083> Disintegration Testing for Bilayer Tablets ensures that bilayer tablets disintegrate within a specified time frame, which is essential for product safety and efficacy.

    Consequences of Not Performing the Test:

    Non-compliance with this standard can result in product recalls, regulatory penalties, or even market withdrawal.

    Industries and Sectors That Require This Testing:

    The test is required by various industries, including pharmaceuticals, cosmetics, food and beverages, and veterinary medicine.

    Risk Factors and Safety Implications:

    Inadequate disintegration of bilayer tablets can lead to reduced product efficacy, increased risk of adverse reactions, or even toxicity.

    Quality Assurance and Quality Control Aspects:

    Eurolabs USP <2083> Disintegration Testing for Bilayer Tablets is designed to ensure quality assurance and control throughout the testing process.

    Why This Test Contributes to Product Safety and Reliability:

    The test ensures that bilayer tablets disintegrate within a specified time frame, which enhances product safety and efficacy.

    Competitive Advantages of Having This Testing Performed:

    Eurolabs USP <2083> Disintegration Testing for Bilayer Tablets provides customers with a competitive advantage by ensuring compliance with regulatory requirements and maintaining high product quality standards.

    Cost-Benefit Analysis of Performing the Test:

    While there may be initial costs associated with testing, these are outweighed by the benefits of improved product safety, efficacy, and regulatory compliance.

    Why This Specific Test is Needed and Required:

    The USP <2083> Disintegration Testing for Bilayer Tablets is essential to ensure that bilayer tablets disintegrate within a specified time frame, which is critical for product safety and efficacy.

    Business and Technical Reasons for Conducting the Test:

    Eurolabs customers require this testing service due to its importance in ensuring regulatory compliance, maintaining high product quality standards, and minimizing risks associated with inadequate disintegration of bilayer tablets.

    Consequences of Not Performing the Test:

    Non-compliance with this standard can result in severe consequences, including product recalls, regulatory penalties, or even market withdrawal.

    Industries and Sectors That Require This Testing:

    The test is required by various industries, including pharmaceuticals, cosmetics, food and beverages, and veterinary medicine.

    Risk Factors and Safety Implications:

    Inadequate disintegration of bilayer tablets can lead to reduced product efficacy, increased risk of adverse reactions, or even toxicity.

    Quality Assurance and Quality Control Aspects:

    Eurolabs USP <2083> Disintegration Testing for Bilayer Tablets is designed to ensure quality assurance and control throughout the testing process.

    Why This Test Contributes to Product Safety and Reliability:

    The test ensures that bilayer tablets disintegrate within a specified time frame, which enhances product safety and efficacy.

    Competitive Advantages of Having This Testing Performed:

    Eurolabs USP <2083> Disintegration Testing for Bilayer Tablets provides customers with a competitive advantage by ensuring compliance with regulatory requirements and maintaining high product quality standards.

    Cost-Benefit Analysis of Performing the Test:

    While there may be initial costs associated with testing, these are outweighed by the benefits of improved product safety, efficacy, and regulatory compliance.

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