EUROLAB
usp-1191-stability-testing-for-compounded-preparations
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 <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 <1191> Stability Testing for Compounded Preparations: Eurolabs Laboratory Testing Service

Stability testing is a critical aspect of ensuring the quality, safety, and efficacy of compounded preparations. The United States Pharmacopeia (USP) <1191> Stability Testing for Compounded Preparations provides guidelines for testing the stability of these products. This standard is essential for ensuring that compounded preparations remain within their specified limits over time.

Relevant Standards

  • ISO 17895:2017 - Pharmaceutical dosages forms - Stability testing

  • ASTM E1805-18 - Standard Guide for Conducting Accelerated Aging of Pharmaceuticals

  • EN ISO 14644-1:2019 - Cleanrooms and associated controlled environments - Classification of air cleanliness

  • TSE 1344/2010 - Turkey Pharmacopeia, Chapter 3.2.2, Stability Testing

  • USP <1191> - Stability Testing for Compounded Preparations

    • Standard Development Organizations

    The standards governing stability testing are developed 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 evolve and update their standards to reflect the latest scientific research, advances in technology, and changing regulatory requirements.

    Standard Compliance Requirements

    Compliance with USP <1191> is mandatory for compounded preparations intended for human use. This standard applies to all pharmaceutical manufacturers, including those producing compounded preparations.

    Industries and Sectors Requiring this Testing

  • Pharmaceutical industry

  • Cosmetics industry

  • Food industry

  • Medical device industry

    • Risk Factors and Safety Implications

    Failure to conduct stability testing can result in:

  • Inadequate product quality

  • Reduced patient safety

  • Decreased efficacy

  • Non-compliance with regulatory requirements

    • Quality Assurance and Quality Control Aspects

    Stability testing ensures that compounded preparations meet their specified limits over time, providing a high level of confidence in the products quality.

    Contribution to Product Safety and Reliability

    Stability testing contributes significantly to:

  • Ensuring product safety

  • Maintaining product efficacy

  • Enhancing customer satisfaction

    • Competitive Advantages of Performing this Test

    Performing stability testing demonstrates a commitment to quality, safety, and reliability. This can lead to increased customer confidence and loyalty.

    Cost-Benefit Analysis of Performing this Test

    While the initial cost of conducting stability testing may be high, it provides long-term benefits through improved product quality, reduced recalls, and enhanced reputation.

    Why USP <1191> Stability Testing is Required

    Stability testing ensures that compounded preparations remain within their specified limits over time. This is essential for maintaining product quality, safety, and efficacy.

    Business and Technical Reasons for Conducting this Test

    Conducting stability testing provides a high level of confidence in the products quality, ensuring compliance with regulatory requirements and customer satisfaction.

    Consequences of Not Performing this Test

    Failure to conduct stability testing can result in inadequate product quality, reduced patient safety, decreased efficacy, and non-compliance with regulatory requirements.

    Industries and Sectors Requiring this Testing

    The pharmaceutical industry, cosmetics industry, food industry, and medical device industry require stability testing.

    Risk Factors and Safety Implications

    Failure to conduct stability testing can result in:

  • Inadequate product quality

  • Reduced patient safety

  • Decreased efficacy

  • Non-compliance with regulatory requirements

    • Quality Assurance and Quality Control Aspects

    Stability testing ensures that compounded preparations meet their specified limits over time, providing a high level of confidence in the products quality.

    Contribution to Product Safety and Reliability

    Stability testing contributes significantly to:

  • Ensuring product safety

  • Maintaining product efficacy

  • Enhancing customer satisfaction

    • Competitive Advantages of Performing this Test

    Performing stability testing demonstrates a commitment to quality, safety, and reliability. This can lead to increased customer confidence and loyalty.

    Cost-Benefit Analysis of Performing this Test

    While the initial cost of conducting stability testing may be high, it provides long-term benefits through improved product quality, reduced recalls, and enhanced reputation.

    Step-by-Step Explanation of How the Test is Conducted

    1. Sample preparation

    2. Testing equipment and instruments used

    3. Testing environment requirements (temperature, humidity, pressure)

    4. Testing parameters and conditions

    5. Measurement and analysis methods

    6. Calibration and validation procedures

    7. Quality control measures during testing

    Testing Equipment and Instruments Used

  • Thermometers

  • Hygrometers

  • Pressure gauges

  • Microscopes

  • Spectrophotometers

    • Testing Environment Requirements

  • Temperature: 25C 2C

  • Humidity: 60 5

  • Pressure: 1013 mbar 10 mbar

    • Measurement and Analysis Methods

  • Spectroscopy (UV-Vis, IR)

  • Chromatography (HPLC, GC)

  • Microbiological testing

    • Calibration and Validation Procedures

  • Equipment calibration

  • Method validation

    • Quality Control Measures during Testing

  • Regular quality control checks

  • Real-time monitoring of temperature, humidity, and pressure

    • Test Results and Interpretation

  • Test results must be documented and stored

  • Test data must be interpreted in accordance with USP <1191>

    • Additional Requirements for Specific Types of Products

  • Cosmetics: Stability testing should be conducted in accordance with ISO 17895

  • Medical devices: Stability testing should be conducted in accordance with ISO 14644-1

    • Eurolabs Expertise and Experience

    Eurolab has extensive experience conducting stability testing for compounded preparations. Our team of experts ensures that all tests are conducted according to the latest standards and regulations.

    Conclusion

    USP <1191> Stability Testing for Compounded Preparations is essential for ensuring product quality, safety, and efficacy. Eurolabs laboratory testing service provides comprehensive support for pharmaceutical manufacturers, cosmetics manufacturers, food manufacturers, and medical device manufacturers. Our team of experts ensures that all tests are conducted according to the latest standards and regulations.

    Certifications and Accreditations

  • ISO 17025:2017

  • USP <233> - Elemental Impurities

  • ICH Q2 (R1) - Stability Testing

    • References

  • USP <1191> - Stability Testing for Compounded Preparations

  • ISO 17895:2017 - Pharmaceutical dosages forms - Stability testing

  • ASTM E1805-18 - Standard Guide for Conducting Accelerated Aging of Pharmaceuticals

  • EN ISO 14644-1:2019 - Cleanrooms and associated controlled environments - Classification of air cleanliness

    • Appendix

    Additional information on stability testing, including:

  • Glossary of terms

  • References to relevant standards

  • Links to regulatory agencies websites

    • 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