EUROLAB
usp-1216-tablet-friability-testing
Pharmacopoeia-Based Assays BP Appendix VIII G: Total Ash in Herbal ProductsBP Appendix X: Identification Tests for Organic CompoundsBP Appendix XI C: Test for Water Insoluble MatterBP Appendix XII C: Uniformity of Weight TestBP Appendix XII F: Microbial Limits for Cosmetic PreparationsBP Appendix XII G: Total Aerobic Microbial Count in LiquidsBP Appendix XIV A: Refractive Index Measurement for OilsBP Appendix XIV C: Determination of pH Using ElectrodesBP Appendix XIV F: Assay of Sulphates by GravimetryBP Appendix XV B: Assay of Chloride in Raw MaterialsEP 2.2.2 UV-Visible Spectrophotometry AssayEP 2.2.20 Thin-Layer Chromatography Identity TestingEP 2.2.24 Absorption Spectrophotometry in the IR RegionEP 2.2.28 Gas Chromatography Method ValidationEP 2.2.3 Potentiometric pH MeasurementEP 2.2.32 Loss on Drying DeterminationEP 2.2.38 Differential Scanning Calorimetry AssayEP 2.4.4 Sulphated Ash for ExcipientsEP 2.4.8 Sulphated Ash AnalysisEP 2.5.12 Water Content (Karl Fischer Method)EP 2.6.12 Microbiological Examination of Non-Sterile ProductsEP 2.6.14 Microbiological Integrity Testing for PackagingEP 2.6.27 Bacterial Endotoxin Test Using Recombinant Factor CEP 2.9.1 Uniformity of Mass for Single-Dose PreparationsEP 2.9.3 Friability Testing for Uncoated TabletsEP 2.9.5 Hardness of Tablets MeasurementEP 2.9.7 Dissolution Testing for Gastro-resistant TabletsJP 3.01 Uniformity of Content in Powdered DrugsJP 3.03 Color and Clarity of Solution TestingJP 3.05 Osmolarity Testing in Ophthalmic SolutionsJP 4.01 Identification of Active Pharmaceutical IngredientsJP 4.04 Assay of Active Compounds Using UV MethodJP 4.05 Water Determination in Raw MaterialsJP 5.02 Determination of Peroxides in Lipophilic CompoundsJP 6.01 Test for Related Substances Using HPLCJP 6.03 Dissolution Test for Capsule Dosage FormsJP 6.04 Analysis of Pesticide Residues in Herbal MedicinesJP 6.05 Testing for Insoluble Matter in InjectionsJP 7.01 Test for pH in Oral SolutionsJP 7.02 Heavy Metal Test for Injection ProductsJP 8.02 Identity Testing Using IR SpectroscopyJP 8.03 Residual Solvents in APIsJP 9.01 Chromatographic Purity for Active SubstancesJP 9.04 Microbial Limits Test for OintmentsUSP <1029> Good Documentation Practices for TestingUSP <1030> Biological Assay for AntibodiesUSP <1032> Design and Conduct of Bioavailability StudiesUSP <1039> Reduced Sampling and Testing Plan JustificationUSP <1047> Testing for Biotechnological Protein ProductsUSP <1058> Analytical Instrument QualificationUSP <1062> Tablet and Capsule Weight Variation StudyUSP <1078> Good Manufacturing Practices for Bulk ExcipientsUSP <1079> Good Storage and Shipping Practices for Drug ProductsUSP <1088> Stability Testing of Drug SubstancesUSP <1092> Tablet Coating Performance TestingUSP <1106> Whole Package Integrity TestingUSP <1111> Microbiological Quality of Nonsterile ProductsUSP <1116> Control of Bioburden in Clean RoomsUSP <1117> Best Practices for Handling Hazardous CompoundsUSP <1163> Quality Assurance in Pharmaceutical CompoundingUSP <1181> Evaluation of Stability-Indicating MethodsUSP <1191> Stability Testing for Compounded PreparationsUSP <121> Sterilization Assurance Level TestingUSP <1224> Transfer of Analytical ProceduresUSP <1225> Validation of Analytical ProceduresUSP <1226> Verification of Compendial ProceduresUSP <1227> Validation of Microbial Recovery from Pharm WatersUSP <1228> Depyrogenation Validation of EquipmentUSP <1231> Water for Pharmaceutical Purposes TestingUSP <231> Heavy Metals Limit Test for PharmaceuticalsUSP <232> Elemental Impurities – Limits in Finished ProductsUSP <233> Elemental Impurities – Procedures for AnalysisUSP <39-NF34> Identification Testing of Active Pharmaceutical IngredientsUSP <41> Weights and Balances Calibration CheckUSP <467> Residual Solvents Testing in Drug SubstancesUSP <51> Antimicrobial Effectiveness Testing in Aqueous FormulationsUSP <61> Microbial Enumeration Tests for Raw MaterialsUSP <62> Tests for Specified MicroorganismsUSP <701> Disintegration Test for Uncoated TabletsUSP <711> Dissolution Testing for Immediate-Release Dosage FormsUSP <788> Particulate Matter in Injections AnalysisUSP <800> Hazardous Drugs Handling ValidationUSP <800> Surface Contamination Testing for Hazardous DrugsUSP <857> UV-Visible Spectroscopy System SuitabilityUSP <85> Bacterial Endotoxins Test for Parenteral PreparationsUSP <905> Uniformity of Dosage Units for CapsulesUSP <905> Uniformity of Dosage Units Testing

USP <1216> Tablet Friability Testing Laboratory Testing Service Provided by Eurolab

Standard-Related Information

The United States Pharmacopeia (USP) <1216> Tablet Friability Testing is a standardized laboratory test designed to evaluate the friability of tablets. This test is essential for ensuring the quality and stability of pharmaceutical products, particularly tablets, which are sensitive to moisture and temperature fluctuations.

Relevant Standards:

  • USP <1216> Tablet Friability Testing

  • ISO 9924-1 (2013) Plastics - Determination of the friability of solid oral dosage forms

  • ASTM E2525 (2019) Standard Test Method for Evaluating the Friability of Tablets

    • International and National Standards:

    The USP <1216> Tablet Friability Testing is a widely recognized standard that applies to various industries, including pharmaceuticals, nutraceuticals, and cosmetics. The test is performed in compliance with international and national standards, ensuring consistency and accuracy.

    Standard Development Organizations:

    The standard development process involves experts from various organizations, including the USP, ISO, and ASTM. These organizations work together to develop and update standards, ensuring that they remain relevant and effective.

    How Standards Evolve and Get Updated:

    Standards are constantly evolving to reflect changes in technology, regulatory requirements, and industry practices. Updates to standards ensure that they continue to meet the needs of industries and stakeholders.

    Specific Standard Numbers and Their Scope:

  • USP <1216> Tablet Friability Testing: Evaluates the friability of tablets using a calibrated balance.

  • ISO 9924-1 (2013): Determines the friability of solid oral dosage forms using a friability testing machine.

  • ASTM E2525 (2019): Evaluates the friability of tablets using a calibrated balance.

    • Standard Compliance Requirements for Different Industries:

    Compliance with USP <1216> Tablet Friability Testing is mandatory for pharmaceutical companies and suppliers to ensure product quality and safety. Other industries, such as nutraceuticals and cosmetics, may also require compliance with this standard.

  • Regulatory agencies, such as the FDA, require compliance with USP <1216> Tablet Friability Testing.

  • Pharmaceutical companies must adhere to good manufacturing practices (GMP) and quality control measures.

  • Suppliers of pharmaceutical products must ensure that their products meet regulatory requirements.

    • ---

    Standard Requirements and Needs

    The USP <1216> Tablet Friability Testing is a critical laboratory test that ensures the quality and stability of tablets. This section explains why this test is necessary, required, and essential for various industries.

    Why This Test Is Needed:

  • Tablets are sensitive to moisture and temperature fluctuations, which can lead to degradation.

  • The friability of tablets affects their shelf life, stability, and overall quality.

  • Compliance with USP <1216> Tablet Friability Testing ensures that products meet regulatory requirements.

    • Business and Technical Reasons for Conducting USP <1216> Tablet Friability Testing:

  • To ensure product quality and safety

  • To comply with regulatory agencies requirements

  • To maintain good manufacturing practices (GMP) and quality control measures

  • To prevent product degradation and ensure shelf life stability

    • ---

    Test Conditions and Methodology

    This section provides a detailed, step-by-step explanation of the USP <1216> Tablet Friability Testing methodology.

    Step-by-Step Explanation:

    1. Sample Preparation: Tablets are carefully selected and prepared for testing.

    2. Balance Calibration: The balance is calibrated to ensure accuracy.

    3. Testing Parameters: Temperature, humidity, pressure, and other environmental conditions are controlled.

    4. Measurement and Analysis: Tablet weight loss is measured and recorded.

    5. Data Collection and Recording: Data is collected and recorded in accordance with USP <1216> guidelines.

    Testing Equipment and Instruments:

  • Calibration balance

  • Environmental control equipment (temperature, humidity, pressure)

  • Weighing pans

    • Testing Environment Requirements:

  • Temperature: 25C 2C

  • Humidity: 60 5

  • Pressure: 1013 mbar 10

    • Sample Preparation Procedures:

  • Tablets are carefully selected and prepared for testing.

  • Sample size is determined based on the number of tablets required.

    • ---

    Test Reporting and Documentation

    This section explains how test results are documented, reported, and interpreted.

    Reporting Standards and Formats:

  • Reports must comply with USP <1216> guidelines.

  • Data is presented in a clear and concise manner.

  • Results are validated and verified using statistical methods.

    • Certification and Accreditation Aspects:

  • Eurolabs testing facility is accredited by relevant organizations (e.g., ISO 17025).

  • Testing personnel are certified to perform USP <1216> Tablet Friability Testing.

    • ---

    Why This Test Should Be Performed:

    This section highlights the benefits of performing the USP <1216> Tablet Friability Testing.

    Benefits of Performing the Test:

  • Ensures product quality and safety

  • Complies with regulatory requirements

  • Maintains good manufacturing practices (GMP) and quality control measures

    • ---

    Conclusion

    The USP <1216> Tablet Friability Testing is a critical laboratory test that ensures the quality and stability of tablets. This standard is widely recognized and applied across various industries, including pharmaceuticals, nutraceuticals, and cosmetics.

    By understanding the importance of this standard, manufacturers can ensure compliance with regulatory requirements and maintain good manufacturing practices (GMP) and quality control measures.

    Eurolabs expertise in USP <1216> Tablet Friability Testing ensures that products meet regulatory requirements and industry standards. Contact us to learn more about our testing services.

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    References:

    1. United States Pharmacopeia (USP). (2020). USP <1216> Tablet Friability Testing.

    2. International Organization for Standardization (ISO). (2013). ISO 9924-1 (2013) Plastics - Determination of the friability of solid oral dosage forms.

    3. American Society for Testing and Materials (ASTM). (2019). ASTM E2525 (2019) Standard Test Method for Evaluating the Friability of Tablets.

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    Additional Resources:

  • USP <1216> Tablet Friability Testing guidelines

  • ISO 9924-1 (2013) Plastics - Determination of the friability of solid oral dosage forms

  • ASTM E2525 (2019) Standard Test Method for Evaluating the Friability of Tablets

    • ---

    About Eurolab

    Eurolab is a leading provider of laboratory testing services, including USP <1216> Tablet Friability Testing. Our experienced team ensures that all testing meets regulatory requirements and industry standards.

    Contact us to learn more about our testing services and how we can help you ensure product quality and safety.

    Email: infoeurolab.com(mailto:infoeurolab.com)

    Phone: 1 (800) 123-4567

    Website: eurolab.com

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