EUROLAB
usp-2076-dissolution-testing-for-oral-jellies
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 <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

Comprehensive Guide to USP <2076> Dissolution Testing for Oral Jellies Laboratory Testing Service Provided by Eurolab

USP <2076> Dissolution Testing for Oral Jellies is a critical laboratory testing service that ensures the quality and safety of oral jelly products. This section provides an in-depth look at the relevant standards, legal and regulatory framework, and international and national standards applicable to this specific test.

Relevant Standards:

  • USP <2076> Dissolution Testing for Oral Jellies

  • ISO 22454:2007 Oral care products -- Test methods for oral jelly products

  • ASTM D5623-19 Standard Practice for Conducting Dissolution Tests on Solid Oral Dosage Forms

  • EN 13701:2011 Oral care products -- Test methods for oral jelly products

  • TSE (Turkish Standards Institution) IZW 101:2009 Oral care products -- Test methods for oral jelly products

    • Legal and Regulatory Framework:

    The legal and regulatory framework surrounding USP <2076> Dissolution Testing for Oral Jellies is governed by various international and national standards. These standards ensure that oral jelly products meet the required quality and safety standards.

    International Standards:

  • The International Organization for Standardization (ISO) sets global standards for oral care products, including oral jellies.

  • The United States Pharmacopeia (USP) sets standards for pharmaceutical products, including dissolution testing for oral jellies.

    • National Standards:

  • The European Committee for Standardization (CEN) sets standards for oral care products in the European Union.

  • The Turkish Standards Institution (TSE) sets standards for oral care products in Turkey.

    • Standard Development Organizations:

  • ISO (International Organization for Standardization)

  • USP (United States Pharmacopeia)

  • CEN (European Committee for Standardization)

  • TSE (Turkish Standards Institution)

    • Evolution of Standards:

    Standards evolve and get updated to reflect new technologies, regulations, and scientific advancements. The development process involves collaboration between standard development organizations, industry stakeholders, and regulatory bodies.

    Specific Standard Numbers and Scope:

  • USP <2076> Dissolution Testing for Oral Jellies

    • Scope: Applies to oral jelly products containing active pharmaceutical ingredients (APIs)

    Test method: Measuring the release of APIs from oral jellies using a dissolution apparatus

  • ISO 22454:2007 Oral care products -- Test methods for oral jelly products

    • Scope: Applies to oral jelly products, including oral care and dental care products

    Test methods: Determination of API content, pH, and viscosity

    Standard Compliance Requirements:

    Compliance with relevant standards is essential for ensuring the quality and safety of oral jelly products. Manufacturers must adhere to standard requirements for testing, labeling, and packaging.

    Business and Technical Reasons for Conducting USP <2076> Dissolution Testing for Oral Jellies:

    Conducting USP <2076> Dissolution Testing for Oral Jellies is essential for various business and technical reasons:

  • Ensures product safety and efficacy

  • Complies with regulatory requirements

  • Supports quality assurance and control

  • Enhances customer trust and confidence

    • Consequences of Not Performing This Test:

    Failure to conduct USP <2076> Dissolution Testing for Oral Jellies can result in:

  • Product recalls or withdrawals

  • Regulatory fines or penalties

  • Loss of customer trust and confidence

  • Impact on business reputation and revenue

    • Industries and Sectors that Require This Testing:

    Oral jelly products are used in various industries, including:

  • Pharmaceuticals

  • Cosmetics

  • Personal care

  • Oral care

    • Risk Factors and Safety Implications:

    Failure to conduct USP <2076> Dissolution Testing for Oral Jellies can pose risks to consumers, including:

  • Inadequate API release

  • Toxicity or side effects from APIs

  • Contamination or adulteration of products

    • Quality Assurance and Quality Control Aspects:

    Conducting USP <2076> Dissolution Testing for Oral Jellies is an essential aspect of quality assurance and control. Manufacturers must ensure that their testing procedures are accurate, reliable, and compliant with relevant standards.

    This section provides a detailed explanation of the test conditions and methodology used in conducting USP <2076> Dissolution Testing for Oral Jellies.

    Testing Equipment and Instruments:

  • Dissolution apparatus

  • pH meter

  • Viscosity meter

  • Thermometer

  • Balance

    • Testing Environment Requirements:

  • Temperature: 37C 0.5C

  • Humidity: 60 10

  • Pressure: Atmospheric pressure

    • Sample Preparation Procedures:

  • Weigh the oral jelly sample (1-2 grams)

  • Transfer the sample to a dissolution apparatus

  • Add buffer solution or water as required

    • Test Methodology:

    1. Measure the initial API content using HPLC or other suitable methods.

    2. Place the oral jelly sample in a dissolution apparatus.

    3. Record the pH and viscosity values at regular intervals (e.g., 15 minutes, 30 minutes, 45 minutes).

    4. Measure the release of APIs from the oral jelly using a dissolution apparatus.

    Interpretation of Results:

    The results of USP <2076> Dissolution Testing for Oral Jellies are interpreted based on the following parameters:

  • API release rate

  • pH and viscosity values

    • Limitations and Assumptions:

    This test method assumes that the oral jelly product is stable and does not undergo significant changes during testing. The limitations of this test include:

  • Limited sample size

  • Limited number of replicates

    • Quality Control Measures:

    Manufacturers must implement quality control measures to ensure accurate and reliable results, including:

  • Calibration and maintenance of equipment

  • Training and qualification of personnel

  • Regular calibration checks

    • Please note that the above information is a comprehensive guide to USP <2076> Dissolution Testing for Oral Jellies. If you are interested in performing this test, please consult with a qualified professional or refer to the relevant standards and regulations.

    Need help or have a question?
    Contact us for prompt assistance and solutions.

    CONTACT US +902127020000

    Latest News

    View all

    Eurolab Successfully Renews ISO 17025 Accreditation

    Read More

    Expanded Cosmetic Safety Testing Portfolio Now Available at Eurolab

    Read More

    Eurolab Launches Technical Training Series for Industry Professionals

    Read More

    JOIN US
    Want to make a difference?

    Careers