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usp-905-uniformity-of-dosage-units-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 <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 for Capsules

USP <905> Uniformity of Dosage Units Testing: Eurolabs Laboratory Testing Service

The Uniformity of Dosage Units testing, as specified in USP <905>, is a critical quality control test that ensures the uniformity and consistency of dosage units in pharmaceutical products. This test is essential for ensuring product safety, efficacy, and compliance with regulatory requirements.

Relevant Standards

The relevant standards governing USP <905> Uniformity of Dosage Units Testing include:

  • USP <905> Uniformity of Dosage Units, which outlines the testing requirements for uniformity of dosage units.

  • ISO 11292:2009 (IDF/TS 11400), which provides guidelines for the analysis of active pharmaceutical ingredients in dosage forms.

  • ASTM E2586-09, which specifies the test method for evaluating the uniformity of dosage units.

  • EN 12457-2:2011, which outlines the requirements for testing uniformity of dosage units.

    • Legal and Regulatory Framework

    The legal and regulatory framework surrounding USP <905> Uniformity of Dosage Units Testing is governed by various regulations, including:

  • US FDA Guidelines, which require pharmaceutical manufacturers to conduct uniformity of dosage units testing.

  • EMA Guidelines, which specify the requirements for uniformity of dosage units testing in Europe.

  • ICH Q6A, which outlines the guidelines for testing and documentation of active pharmaceutical ingredients.

    • Standard Development Organizations

    Standard development organizations play a crucial role in developing and updating standards related to USP <905> Uniformity of Dosage Units Testing. Some notable organizations include:

  • USP (United States Pharmacopeia), which develops and publishes pharmacopeial standards.

  • ISO (International Organization for Standardization), which develops and publishes international standards.

  • ASTM (American Society for Testing and Materials), which develops and publishes technical standards.

    • Standard Evolution and Update

    Standards related to USP <905> Uniformity of Dosage Units Testing evolve over time to reflect advancements in technology, changes in regulations, and new scientific discoveries. Standard development organizations continuously review and update standards to ensure they remain relevant and effective.

    Specific Standard Numbers and Scope

    The following standard numbers and scopes are relevant to USP <905> Uniformity of Dosage Units Testing:

  • USP <905>: Uniformity of Dosage Units testing.

  • ISO 11292:2009 (IDF/TS 11400): Analysis of active pharmaceutical ingredients in dosage forms.

  • ASTM E2586-09: Test method for evaluating uniformity of dosage units.

    • Standard Compliance Requirements

    Pharmaceutical manufacturers must comply with standard requirements for USP <905> Uniformity of Dosage Units Testing. Compliance requirements vary depending on the country, industry, and type of product.

    The Uniformity of Dosage Units testing is a critical quality control test that ensures product safety, efficacy, and compliance with regulatory requirements.

    Business and Technical Reasons for Conducting USP <905> Uniformity of Dosage Units Testing

    Conducting USP <905> Uniformity of Dosage Units Testing provides numerous benefits, including:

  • Product Safety: Ensures uniformity and consistency of dosage units.

  • Compliance with Regulations: Meets regulatory requirements for pharmaceutical products.

  • Quality Control: Validates the quality of dosage units.

  • Innovation and Research Development: Supports innovation and research development.

    • Consequences of Not Performing USP <905> Uniformity of Dosage Units Testing

    Failure to conduct USP <905> Uniformity of Dosage Units Testing can have serious consequences, including:

  • Product Recalls: Due to non-compliance with regulatory requirements.

  • Financial Losses: Resulting from product recalls and legal liabilities.

  • Loss of Customer Confidence: Due to non-compliance with regulatory requirements.

    • Industries and Sectors that Require USP <905> Uniformity of Dosage Units Testing

    The following industries and sectors require USP <905> Uniformity of Dosage Units Testing:

  • Pharmaceutical Industry

  • Biotechnology Industry

  • Cosmetics Industry

    • Risk Factors and Safety Implications

    Risk factors associated with non-compliance with USP <905> Uniformity of Dosage Units Testing include:

  • Product Contamination: Due to non-uniform dosage units.

  • Inadequate Product Efficacy: Resulting from non-uniform dosage units.

  • Patient Harm: Due to product contamination and inadequate product efficacy.

    • Quality Assurance and Quality Control Aspects

    Conducting USP <905> Uniformity of Dosage Units Testing ensures quality assurance and control aspects, including:

  • Product Safety

  • Compliance with Regulations

  • Innovation and Research Development

    • Competitive Advantage

    Conducting USP <905> Uniformity of Dosage Units Testing provides a competitive advantage by ensuring product safety, efficacy, and compliance with regulatory requirements.

    The test methodology for USP <905> Uniformity of Dosage Units Testing involves the following steps:

    1. Sampling: Random sampling of dosage units.

    2. Weighing: Weighing of individual dosage units.

    3. Analysis: Analysis of active pharmaceutical ingredients in each dosage unit.

    4. Calculation: Calculation of uniformity and consistency of dosage units.

    Instrumentation

    The instrumentation used for USP <905> Uniformity of Dosage Units Testing includes:

  • Balance

  • Analytical Balance

  • Spectrophotometer

    • The test report for USP <905> Uniformity of Dosage Units Testing must include the following information:

    1. Sample Description: Description of the sample tested.

    2. Testing Methodology: Description of the testing methodology used.

    3. Results: Results of the analysis, including uniformity and consistency of dosage units.

    4. Conclusion: Conclusion drawn from the results.

    Certificates and Compliance

    Certificates and compliance documents must be provided to demonstrate compliance with USP <905> Uniformity of Dosage Units Testing requirements.

    The test validation for USP <905> Uniformity of Dosage Units Testing involves:

    1. Validation Protocol: Development of a validation protocol.

    2. Testing: Testing and analysis of the method.

    3. Evaluation: Evaluation of the results.

    4. Report: Report on the validation study.

    Test Method Validation Criteria

    The test method validation criteria for USP <905> Uniformity of Dosage Units Testing include:

    1. Specificity

    2. Sensitivity

    3. Precision

    4. Accuracy

    Re-validation and Maintenance

    USP <905> Uniformity of Dosage Units Testing is a critical quality control test that ensures product safety, efficacy, and compliance with regulatory requirements. Conducting this testing provides numerous benefits, including product safety, compliance with regulations, innovation and research development, and competitive advantage.

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