EUROLAB
usp-905-uniformity-of-dosage-units-for-capsules
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 <1216> Tablet Friability TestingUSP <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 Testing

USP <905> Uniformity of Dosage Units for Capsules Laboratory Testing Service

Ensuring Product Safety and Reliability

As a leading provider of laboratory testing services, Eurolab is committed to helping pharmaceutical manufacturers ensure the quality and safety of their products. One critical aspect of this commitment is the provision of USP <905> Uniformity of Dosage Units for Capsules testing services. In this article, we will delve into the world of standards, regulations, and laboratory testing, providing a comprehensive guide to understanding the importance of this specific test.

Standard-Related Information

The testing service offered by Eurolab is governed by various international and national standards, including:

  • ISO 8655: Standard for pipettes

  • ASTM E691: Standard practice for conducting an interlaboratory study to determine the precision of a test method

  • EN ISO 12097: Standard for dosing devices

  • TSE (Turkish Standards Institution): Turkish standards for pharmaceuticals and medical devices

    • These standards outline the requirements for testing equipment, sampling procedures, and measurement methods. They also provide guidelines for ensuring data accuracy, precision, and reliability.

    Standard Development Organizations

    Standards development organizations play a crucial role in shaping the laboratory testing landscape. These organizations include:

  • International Organization for Standardization (ISO): Develops international standards for various industries

  • American Society for Testing and Materials (ASTM): Develops and publishes voluntary consensus standards

  • Deutsches Institut für Normung (DIN): Develops national standards in Germany

    • These organizations collaborate to ensure that standards are harmonized across regions, facilitating global trade and reducing regulatory hurdles.

    Evolution of Standards

    Standards evolve over time as new technologies emerge and best practices are refined. Eurolab stays up-to-date with the latest developments by:

  • Participating in industry events and conferences

  • Engaging with standard development organizations

  • Staying current with relevant publications and research findings

    • This commitment to staying informed enables Eurolab to adapt quickly to changing regulatory requirements.

    Standard Compliance Requirements

    Pharmaceutical manufacturers must comply with a range of standards, regulations, and guidelines. Failure to do so can result in costly delays, product recalls, or even loss of market access.

    Business and Technical Reasons for Conducting USP <905> Testing

    Conducting USP <905> Uniformity of Dosage Units for Capsules testing is essential for several reasons:

  • Ensures product safety and reliability

  • Complies with regulatory requirements

  • Enhances customer confidence and trust

  • Supports international market access and trade facilitation

    • Test Conditions and Methodology

    The test involves measuring the weight variation of capsules to ensure uniformity. The process involves:

    1. Sample preparation: Preparing a representative sample of capsules for testing

    2. Testing equipment: Using calibrated and validated equipment to measure weight variations

    3. Measurement and analysis: Recording and analyzing data to determine weight variability

    Test Reporting and Documentation

    Results are documented in a comprehensive test report, which includes:

  • Test parameters and conditions

  • Sample preparation procedures

  • Measurement and analysis methods

  • Results interpretation

  • Certification and accreditation details

    • The report format is structured according to relevant standards, ensuring transparency and ease of understanding.

    Why This Test Should be Performed

    Performing USP <905> Uniformity of Dosage Units for Capsules testing offers numerous benefits, including:

  • Risk assessment and mitigation: Identifying potential issues before they impact product quality or customer safety

  • Quality assurance and compliance: Ensuring products meet regulatory requirements and industry standards

  • Competitive advantages: Demonstrating commitment to quality and customer trust

    • Why Eurolab Should Provide This Service

    Eurolabs expertise, state-of-the-art equipment, and qualified personnel make it an ideal partner for pharmaceutical manufacturers. Our services include:

  • Accreditation and certification: Ensuring compliance with regulatory requirements

  • Quality management systems: Implementing best practices to ensure data accuracy and precision

  • Turnaround time and efficiency: Providing fast and efficient testing services

    • Conclusion

    USP <905> Uniformity of Dosage Units for Capsules testing is a critical aspect of pharmaceutical manufacturing. By understanding the importance of this test, manufacturers can ensure product safety and reliability while complying with regulatory requirements.

    At Eurolab, we are committed to providing expert laboratory testing services that support our clients success. Our team of qualified professionals, state-of-the-art equipment, and commitment to quality make us an ideal partner for pharmaceutical manufacturers.

    References

  • USP <905> Uniformity of Dosage Units

  • ISO 8655:2019 Pipettes - Requirements and Testing Methods

  • ASTM E691-11 Standard Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method

  • EN ISO 12097:2018 Dosing devices - Requirements

    • About Eurolab

    Eurolab is a leading provider of laboratory testing services, committed to ensuring product safety and reliability. Our team of qualified professionals and state-of-the-art equipment make us an ideal partner for pharmaceutical manufacturers.

    Contact Us:

    Phone: 1 800-1234

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

    Website: eurolab.com

    Disclaimer

    This article is for general information purposes only and should not be considered as legal or regulatory advice. Please consult relevant standards, regulations, and guidelines for specific requirements.

    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