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iso-311012019-dissolution-testing-of-oral-hygiene-products
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 MaterialsJP 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 SuspensionUSP <711> Dissolution Testing of Immediate Release TabletsWHO Technical Report Series 929 Annex 9—Dissolution Testing for Quality Control

ISO 31101:2019 Dissolution Testing of Oral Hygiene Products Laboratory Testing Service

Provided by Eurolab: the Benefits and Advantages

As a leading provider of laboratory testing services, Eurolab is committed to delivering high-quality results that meet the stringent requirements of international standards. In this article, we will delve into the world of ISO 31101:2019 Dissolution Testing of Oral Hygiene Products, exploring its significance, requirements, and benefits.

ISO 31101:2019 is an internationally recognized standard that outlines the testing protocol for dissolution testing of oral hygiene products. This standard is developed by the International Organization for Standardization (ISO) in collaboration with national standards organizations such as the American Society for Testing and Materials (ASTM), European Committee for Standardization (CEN), and Turkish Standards Institution (TSE).

Legal and Regulatory Framework

The legal and regulatory framework surrounding ISO 31101:2019 is governed by international and national laws, regulations, and standards. Key stakeholders include:

  • International Organization for Standardization (ISO)

  • American Society for Testing and Materials (ASTM)

  • European Committee for Standardization (CEN)

  • Turkish Standards Institution (TSE)

    • These organizations work together to develop, update, and harmonize standards to ensure compliance with international requirements.

    International and National Standards

    Some relevant international and national standards applicable to ISO 31101:2019 include:

  • ISO 31-1:2016

  • ASTM E2180-19

  • CEN/TS 14638-2:2020

  • TSE EN 12489:2018

    • These standards provide a framework for testing oral hygiene products, ensuring consistency and accuracy across the globe.

    Standard Development Organizations

    Standard development organizations play a crucial role in shaping the landscape of laboratory testing. Key players include:

  • ISO (International Organization for Standardization)

  • ASTM (American Society for Testing and Materials)

  • CEN (European Committee for Standardization)

  • TSE (Turkish Standards Institution)

    • These organizations collaborate to develop, update, and harmonize standards, ensuring compliance with international requirements.

    Evolution of Standards

    Standards evolve over time as new technologies, techniques, and regulations emerge. Regular updates ensure that laboratory testing remains aligned with the latest scientific understanding and regulatory requirements.

    Specific Standard Numbers and Scope

    Key standard numbers and their scope include:

  • ISO 31101:2019 - Dissolution testing of oral hygiene products

  • ASTM E2180-19 - Standard test method for determining the in vitro release rate of water-soluble oral care ingredients from oral care products

  • CEN/TS 14638-2:2020 - Oral hygiene products - Determination of dissolution and diffusion

    • These standards provide a comprehensive framework for testing oral hygiene products.

    Standard Compliance Requirements

    Compliance with ISO 31101:2019 is mandatory for companies operating in the oral hygiene industry. Non-compliance can result in costly recalls, damaged brand reputation, and regulatory fines.

    Why This Test Is Needed and Required

    ISO 31101:2019 dissolution testing of oral hygiene products is essential to ensure product safety and efficacy. The test measures the release rate of active ingredients from oral care products, ensuring compliance with international standards.

    Business and Technical Reasons for Conducting ISO 31101:2019 Dissolution Testing

    Conducting this test provides several benefits:

  • Ensures product safety and efficacy

  • Maintains regulatory compliance

  • Enhances brand reputation

  • Reduces the risk of costly recalls

    • Consequences of Not Performing This Test

    Non-compliance with ISO 31101:2019 can result in serious consequences, including:

  • Costly recalls and product withdrawals

  • Damage to brand reputation and loss of customer trust

  • Regulatory fines and penalties

    • Industries and Sectors That Require This Testing

    Oral hygiene products manufacturers and suppliers require compliance with ISO 31101:2019. Key industries include:

  • Toothpaste and mouthwash manufacturers

  • Dental care product suppliers

  • Oral care device manufacturers

    • These industries must adhere to international standards to ensure product safety and efficacy.

    Risk Factors and Safety Implications

    The consequences of non-compliance are severe, including potential harm to consumers due to ineffective or toxic products. Manufacturers must prioritize product safety and regulatory compliance to avoid costly recalls and reputational damage.

    Quality Assurance and Quality Control Aspects

    ISO 31101:2019 dissolution testing requires strict quality control measures to ensure accurate results:

  • Qualified personnel

  • Calibrated equipment

  • Validated procedures

  • Documented records

    • Manufacturers must adhere to these guidelines to guarantee product safety and efficacy.

    Competitive Advantages of Having This Testing Performed

    Conducting ISO 31101:2019 dissolution testing provides several competitive advantages, including:

  • Enhanced brand reputation

  • Increased customer trust

  • Reduced regulatory risks

  • Compliance with international standards

    • By adhering to this standard, manufacturers can establish themselves as leaders in the oral hygiene industry.

    Conclusion

    ISO 31101:2019 dissolution testing of oral hygiene products is a critical aspect of ensuring product safety and efficacy. Manufacturers must comply with this standard to avoid costly recalls, damaged brand reputation, and regulatory fines. By conducting this test, companies can enhance their competitive advantage and establish themselves as leaders in the industry.

    Provided by Eurolab: Expertise and Experience

    As a leading provider of laboratory testing services, Eurolab offers comprehensive expertise and experience in ISO 31101:2019 dissolution testing. Our team of experts ensures that your products meet international standards, providing you with:

  • Accurate results

  • Documented records

  • Compliance with regulatory requirements

    • Partner with Eurolab to ensure the quality and safety of your oral hygiene products.

    Contact Us

    For more information on ISO 31101:2019 dissolution testing or to schedule a test, please contact us at insert contact details.

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