EUROLAB
usp-1181-evaluation-of-stability-indicating-methods
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 <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 CapsulesUSP <905> Uniformity of Dosage Units Testing

USP <1181> Evaluation of Stability-Indicating Methods Laboratory Testing Service Provided by Eurolab: A Comprehensive Guide

Standard-Related Information

The USP <1181> Evaluation of Stability-Indicating Methods is a critical laboratory test that evaluates the stability-indicating properties of pharmaceutical compounds. This test is governed by various international and national standards, including ISO 17025, ASTM E2603, EN ISO/IEC 17025, TSE 1318, and USP <1221>. These standards ensure that laboratories conducting this test adhere to strict guidelines, ensuring the accuracy and reliability of the results.

The legal and regulatory framework surrounding this testing service is primarily driven by the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), and other national regulatory agencies. These organizations mandate the use of stability-indicating methods to ensure that pharmaceutical products are stable and maintain their potency over time.

International standards, such as ISO 17025, emphasize the importance of laboratory competence and the need for laboratories to adhere to specific requirements, including:

  • Laboratory accreditation

  • Calibration and maintenance of testing equipment

  • Use of standardized test procedures

  • Documentation and record-keeping

    • National standards, like TSE 1318, specify additional requirements, such as:

  • Sampling procedures

  • Test method validation

  • Data analysis and interpretation

    • Standard Development Organizations

    The development of international and national standards is primarily driven by organizations, such as:

  • 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, publish, and update standards that ensure laboratory testing services are conducted with consistency and reliability.

    Evolution of Standards

    Standards evolve over time as new technologies emerge, and scientific understanding improves. Updates to standards occur through a collaborative process involving industry experts, regulatory agencies, and standard development organizations. This ensures that standards remain relevant and effective in supporting the accuracy and reliability of laboratory testing services.

    Some notable examples of updated standards include:

  • ISO 17025:2018

  • ASTM E2603-19

  • EN ISO/IEC 17025:2017

    • Specific Standard Numbers and Scope

    The following standard numbers are relevant to USP <1181> Evaluation of Stability-Indicating Methods testing:

  • ISO 17025:2018 - General requirements for the competence of testing and calibration laboratories

  • ASTM E2603-19 - Standard Practice for Development and Validation of Analytical Methods for Pharmaceutical Compounds

  • EN ISO/IEC 17025:2017 - General requirements for the competence of testing and calibration laboratories

    • These standards provide detailed guidelines on the requirements for laboratory testing services, including:

  • Laboratory accreditation

  • Test method validation

  • Data analysis and interpretation

    • Standard Compliance Requirements

    Compliance with standard requirements is essential for industries requiring USP <1181> Evaluation of Stability-Indicating Methods testing. These industries include:

  • Pharmaceuticals

  • Biotechnology

  • Cosmetics

  • Food and beverage

    • Failure to comply with standards can result in:

  • Product recalls

  • Regulatory non-compliance

  • Loss of customer confidence

    • Standard Requirements and Needs

    The need for USP <1181> Evaluation of Stability-Indicating Methods testing arises from the requirement for pharmaceutical compounds to be stable over time. This test evaluates the stability-indicating properties of these compounds, ensuring that they maintain their potency and safety profile.

    Conducting this test is essential due to:

  • Regulatory requirements

  • Industry standards

  • Quality assurance and quality control

    • Consequences of not performing this test include:

  • Product failures

  • Regulatory non-compliance

  • Loss of customer confidence

    • Test Conditions and Methodology

    The USP <1181> Evaluation of Stability-Indicating Methods testing is conducted using standardized test procedures, as outlined in the relevant standards. The following steps are involved:

    1. Sample preparation: Collecting and preparing the sample for analysis.

    2. Testing equipment calibration: Ensuring that testing equipment is calibrated and maintained according to standard requirements.

    3. Test method validation: Validating the test method used to evaluate the stability-indicating properties of the pharmaceutical compound.

    4. Data analysis: Analyzing data generated from the test to determine the stability-indicating properties of the compound.

    Test Reporting and Documentation

    Results from the USP <1181> Evaluation of Stability-Indicating Methods testing are documented and reported according to standard requirements. The report should include:

  • Test method used

  • Sample preparation procedures

  • Testing equipment calibration details

  • Data analysis and interpretation

    • The report should be structured to provide clear and concise information on the stability-indicating properties of the pharmaceutical compound.

    Why This Test Should Be Performed

    Conducting USP <1181> Evaluation of Stability-Indicating Methods testing is essential for:

  • Regulatory compliance

  • Industry standards

  • Quality assurance and quality control

    • Failure to perform this test can result in:

  • Product failures

  • Regulatory non-compliance

  • Loss of customer confidence

    • Why Choose Eurolab

    Eurolab offers comprehensive USP <1181> Evaluation of Stability-Indicating Methods testing services, ensuring that our clients meet the required standards. Our laboratory is accredited to ISO 17025 and follows standard procedures for test method validation, data analysis, and interpretation.

    Our team of experts provides:

  • Sample preparation

  • Testing equipment calibration

  • Test method validation

  • Data analysis and interpretation

    • At Eurolab, we ensure that our clients meet regulatory requirements, industry standards, and quality assurance and quality control expectations.

    Need help or have a question?
    Contact us for prompt assistance and solutions.

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