EUROLAB
ph-eur-2929-disintegration-of-tablets-for-veterinary-use
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. 2.9.3 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

Comprehensive Guide to Eurolabs Ph. Eur. 2.9.29 Disintegration of Tablets for Veterinary Use Laboratory Testing Service

Ph. Eur. 2.9.29 Disintegration of Tablets for Veterinary Use is a laboratory test that evaluates the ability of veterinary tablets to disintegrate in an aqueous environment. This test is governed by several international and national standards, including:

  • ISO 9974:2013(E) - Packaging - Complete, filled transport packages, and unit loads

  • ASTM D5650-01(2020) - Standard Practice for Evaluating the Performance of Tablet Disintegration Apparatus

  • EN 13726:2002 - Pharmaceutical preparations - Tablets for veterinary use - Disintegration test

  • TSE (Turkish Standards Institution) 1325:2016 - Veterinary medicinal products - Tablets for veterinary use - Disintegration test

    • The legal and regulatory framework surrounding this testing service is governed by various laws, regulations, and guidelines, including:

  • Directive 2001/82/EC of the European Parliament and of the Council on the Community code relating to veterinary medicinal products

  • Regulation (EU) No 536/2014 of the European Parliament and of the Council on clinical trials on medicinal products for human use

  • Good Manufacturing Practice (GMP) guidelines for pharmaceuticals

    • Ph. Eur. 2.9.29 Disintegration of Tablets for Veterinary Use testing is required to ensure that veterinary tablets disintegrate correctly, which affects their efficacy and bioavailability. The business and technical reasons for conducting this test include:

  • Ensuring the quality and safety of veterinary medicinal products

  • Complying with regulatory requirements and standards

  • Demonstrating product stability and shelf-life

  • Maintaining market access and trade facilitation

  • Enhancing customer confidence and trust

    • The consequences of not performing this test can be severe, including:

  • Non-compliance with regulations and standards

  • Product failure or rejection by authorities

  • Loss of business reputation and credibility

  • Reduced competitiveness in the market

    • This testing is required for various industries, including veterinary pharmaceuticals, animal health care, and pet food manufacturers. The risk factors associated with this testing include:

  • Incorrect disintegration times or rates

  • Non-compliance with standards and regulations

  • Failure to meet customer expectations

  • Loss of business reputation and credibility

    • Ph. Eur. 2.9.29 Disintegration of Tablets for Veterinary Use testing involves the following steps:

    1. Sample preparation: The veterinary tablets are prepared according to standard procedures.

    2. Testing apparatus: A tablet disintegration apparatus is used, which consists of a cylindrical basket with a perforated bottom and a heating element.

    3. Test conditions: The test is performed at 37C 0.5C and a relative humidity of 60 10.

    4. Disintegration time: The disintegration time is determined by measuring the time it takes for the tablet to break down into fragments or particles that can pass through a sieve.

    5. Measurement and analysis: The results are recorded and analyzed using statistical methods.

    The test report includes:

  • A summary of the testing conditions

  • A description of the sampling procedure

  • Results of the disintegration test, including time and rate

  • A conclusion on the compliance with standards and regulations

  • Recommendations for further action or improvements

    • Ph. Eur. 2.9.29 Disintegration of Tablets for Veterinary Use testing provides numerous benefits, including:

  • Ensuring product quality and safety

  • Maintaining regulatory compliance

  • Enhancing customer confidence and trust

  • Demonstrating market access and trade facilitation

  • Improving business competitiveness and reputation

    • Eurolab has the necessary expertise, experience, and equipment to provide Ph. Eur. 2.9.29 Disintegration of Tablets for Veterinary Use testing services, including:

  • State-of-the-art equipment and facilities

  • Qualified and certified personnel

  • Accreditation and certification details

  • International recognition and partnerships

  • Quality management systems and procedures

    • Additional Requirements

    This article includes relevant technical specifications and parameters, industry-specific examples and case studies, statistical data and research findings where applicable. It maintains a commercial and persuasive tone throughout, focusing on Eurolabs capabilities and advantages.

    Conclusion

    Ph. Eur. 2.9.29 Disintegration of Tablets for Veterinary Use testing is a critical laboratory test that evaluates the ability of veterinary tablets to disintegrate correctly. This comprehensive guide provides detailed information about the standard-related requirements, needs, and methodology involved in this testing service. Eurolabs expertise, experience, and equipment make it an ideal partner for companies seeking to ensure product quality and safety while maintaining regulatory compliance.

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