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usp-1191-stability-testing-of-compounded-preparations
Impurity Profiling EMA Guideline on Genotoxic Impurities in PharmaceuticalsEMA Reflection Paper on Low Level ImpuritiesFDA Guidance: Microbial Impurities and Endotoxin LevelsFDA Guidance: Threshold of Toxicological Concern (TTC) for ImpuritiesFDA ICH M3(R2): Impurities in Safety StudiesFDA Q&A on Impurities in Generic Drug ApplicationsFDA Q&A: Managing Impurities in Complex APIsICH E14: QT Interval Evaluation and Impurity ImpactICH M7: Mutagenic Impurity Risk AssessmentICH Q10: Pharmaceutical Quality System for Impurity ManagementICH Q11: Impurity Control Strategy in Drug Substance DevelopmentICH Q12: Lifecycle Management of Impurity Control StrategyICH Q1E: Evaluation of Stability Data Related to Impurity FormationICH Q2(R1): Validation of Analytical Methods for Impurity TestingICH Q3A: Organic Impurity Profiling in Drug SubstancesICH Q3B: Impurity Testing in Finished Drug ProductsICH Q3C: Residual Solvent ProfilingICH Q3D: Elemental Impurity Risk AssessmentICH Q3F: Impurity Guidelines for Biotechnology ProductsICH Q4B: Harmonization of Analytical Procedures for Impurity TestingICH Q5C: Impurity Monitoring in Biotechnological ProductsICH Q6A: Specifications and Acceptance Criteria for ImpuritiesICH S3A: Impurities Arising from Degradation ProductsICH S6: Biotech Product Impurity ProfilingICH S7A: Safety Pharmacology Impurity EvaluationICH S9: Impurities in Oncology ProductsISO 10993-18: Chemical Characterization and Impurity AnalysisISO 17025: Accreditation for Impurity Testing LaboratoriesJP General Rule 2.60: Limit Test for ImpuritiesPh. Eur. 2.2.28: Gas Chromatography for Impurity DetectionPh. Eur. 2.2.38: Thin-Layer Chromatography for ImpuritiesPh. Eur. 2.2.46: Chromatographic Separation for Impurity AnalysisPh. Eur. 2.4.14: Determination of Inorganic ImpuritiesPh. Eur. 2.4.20: Limit Test for Heavy Metals in ImpuritiesPh. Eur. 2.4.24: Related Substances by HPLC in APIsPh. Eur. 2.4.29: Limit Test for Sulfated Ash ImpuritiesPh. Eur. 2.5.13: Oxidizing Impurity TestsPh. Eur. 2.9.40: Uniformity of Dosage Units and Related ImpuritiesPh. Eur. 5.10: Control of Impurities in Substances for Pharmaceutical UsePh. Eur. 5.4: Impurities in Radiopharmaceutical PreparationsUSP <1010>: Analytical Data Integrity in Impurity ReportingUSP <1031>: The Biocompatibility of Materials and ImpuritiesUSP <1051>: Cleaning Validation Limits and Residual ImpuritiesUSP <1058>: Analytical Instrument Qualification for Impurity StudiesUSP <1078>: Good Manufacturing Practices for Impurity ReductionUSP <1085>: Evaluation of Impurity Method PerformanceUSP <1086>: Impurities in Drug SubstancesUSP <1088>: Forced Degradation Studies for Impurity CharacterizationUSP <1091>: Impurity Isolation and Characterization TechniquesUSP <1099>: Acceptable Analytical Performance CriteriaUSP <1121>: Bulk Pharmaceutical Chemicals and Impurity HandlingUSP <1151>: Pharmaceutical Dosage Forms and Impurity ConsiderationUSP <1222>: Terminal Sterilization Impact on ImpuritiesUSP <1224>: Transfer of Impurity Test ProceduresUSP <1225>: Validation of Compendial Procedures for ImpuritiesUSP <1226>: Verification of Compendial Procedures for Impurity DetectionUSP <1231>: Water for Pharmaceutical Purposes and Impurity EffectsUSP <1232>: Water Activity and Impurity StabilityUSP <1241>: Capsules and Shell Impurity InteractionUSP <1251>: Weighing on Analytical Balances for Micro-ImpuritiesUSP <161>: Transdermal Delivery Systems and Impurity ControlUSP <197>: Spectrophotometric Identification of ImpuritiesUSP <233>: Elemental Impurities Profiling Using ICP-MSUSP <41>: Balances Used for Impurity Weight DeterminationUSP <466>: Identification and Quantification of DegradantsUSP <467>: Residual Solvent Testing in APIs and ExcipientsUSP <476>: Impurity Profiling for New Drug ApplicationsUSP <621>: Chromatography Conditions for Impurity IdentificationUSP <730>: Plasma Spectrochemistry for Impurity ProfilingUSP <791>: pH Determination Impact on Impurity SolubilityUSP <797>: Sterile Compounding and Impurity ControlUSP <800>: Hazardous Drug Handling Based on Impurity RiskUSP <851>: Spectrophotometry and Light Scattering for ImpuritiesUSP <853>: Atomic Absorption Spectroscopy for Trace ImpuritiesUSP <857>: UV-Vis Spectroscopy for Impurity QuantificationUSP <85>: Bacterial Endotoxin Limits Related to Impurity SafetyUSP <891>: Nuclear Magnetic Resonance (NMR) for Structural ElucidationUSP <905>: Content Uniformity Related to ImpuritiesUSP <905>: Uniformity of Dosage Units Affected by ImpuritiesUSP <941>: Characterization of Impurity Solubility and pKaWHO TRS 970 Annex 2: Impurity Control in Medicines

USP <1191>: Stability Testing of Compounded Preparations Laboratory Testing Service Provided by Eurolab

USP <1191> is a comprehensive standard that outlines the requirements for stability testing of compounded preparations. The standard is published by the United States Pharmacopeia (USP) and is widely recognized as the gold standard for pharmaceutical and biopharmaceutical products.

Legal and Regulatory Framework

The legal and regulatory framework surrounding USP <1191> is governed by various international and national standards, including:

  • International Organization for Standardization (ISO)

  • American Society for Testing and Materials (ASTM)

  • European Committee for Standardization (CEN)

  • Turkish Standards Institution (TSE)

    • These standards provide a framework for ensuring the quality, safety, and efficacy of compounded preparations.

    Standard Development Organizations

    Standard development organizations play a crucial role in developing and maintaining international and national standards. Some of the key standard development organizations include:

  • ISO

  • ASTM

  • CEN

  • TSE

    • These organizations work together to develop and maintain standards that are recognized globally.

    Evolution of Standards

    Standards evolve over time as new technologies, research findings, and regulatory requirements emerge. The evolution of standards is a continuous process that involves stakeholder input, review, and revision.

    Standard Numbers and Scope

    USP <1191> provides specific standard numbers and their scope for stability testing of compounded preparations. Some of the key standard numbers include:

  • USP <795> for Pharmaceutical Compounding

  • USP <797> for Sterile Compounding

  • USP <800> for Hazardous Drugs

    • These standards provide detailed requirements for stability testing, including temperature, humidity, and light exposure.

    Standard Compliance Requirements

    Different industries have varying standard compliance requirements. For example:

  • Pharmaceutical manufacturers must comply with USP <795>

  • Sterile compounding facilities must comply with USP <797>

  • Hazardous drug handling facilities must comply with USP <800>

    • Compliance with these standards ensures that compounded preparations meet quality, safety, and efficacy standards.

    Why is this specific test needed and required?

    Stability testing of compounded preparations is critical to ensure product safety and efficacy. Compounded preparations are sensitive to environmental conditions such as temperature, humidity, and light exposure, which can affect their stability and potency.

    Business and Technical Reasons for Conducting USP <1191> Testing

    Conducting USP <1191> testing provides several business and technical benefits, including:

  • Ensuring product safety and efficacy

  • Meeting regulatory requirements

  • Enhancing customer confidence and trust

  • Improving market positioning and competitiveness

    • Consequences of Not Performing this Test

    Failure to conduct stability testing can result in serious consequences, including:

  • Product recalls

  • Regulatory actions

  • Loss of customer confidence and trust

  • Damage to brand reputation

    • Industries and Sectors that Require this Testing

    Compounded preparations are used across various industries, including:

  • Pharmaceutical manufacturing

  • Sterile compounding facilities

  • Hazardous drug handling facilities

  • Veterinary medicine

    • These industries require stability testing to ensure product safety and efficacy.

    Risk Factors and Safety Implications

    Stability testing helps identify potential risk factors and safety implications associated with compounded preparations. These risks include:

  • Product contamination

  • Inadequate potency or bioavailability

  • Incorrect labeling or packaging

  • Inadequate storage or handling

    • Addressing these risks ensures product safety and efficacy.

    Quality Assurance and Quality Control Aspects

    USP <1191> emphasizes the importance of quality assurance and quality control in stability testing. These aspects include:

  • Equipment calibration and validation

  • Sample preparation and analysis

  • Data collection and recording

  • Reporting and documentation

    • These measures ensure accurate and reliable test results.

    Competitive Advantages of Having this Testing Performed

    Conducting USP <1191> testing provides several competitive advantages, including:

  • Enhanced customer confidence and trust

  • Improved market positioning and competitiveness

  • Increased brand reputation and credibility

  • Reduced risk of product recalls and regulatory actions

    • Cost-Benefit Analysis of Performing this Test

    The cost-benefit analysis of performing USP <1191> testing is clear. While the initial investment may seem high, the long-term benefits far outweigh the costs.

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

    USP <1191> provides a detailed step-by-step explanation of how stability testing should be conducted. These steps include:

  • Sample preparation

  • Equipment calibration and validation

  • Data collection and recording

  • Reporting and documentation

    • Each step requires careful attention to detail and adherence to standard procedures.

    Temperature, Humidity, and Light Exposure Requirements

    Stability testing involves exposing compounded preparations to various environmental conditions, including temperature, humidity, and light exposure. These requirements are specified in USP <1191> and include:

  • Temperature range: 25C 2C

  • Relative humidity: 60 5

  • Light exposure: 10 hours/day at 1000 lux

    • These conditions simulate real-world scenarios and help identify potential stability issues.

    Equipment Calibration and Validation

    Accurate equipment calibration and validation are critical to ensuring reliable test results. USP <1191> requires that equipment be calibrated and validated according to standard procedures, including:

  • Equipment maintenance and repair

  • Calibration and verification

  • Validation and certification

    • These measures ensure accurate and reliable data collection.

    Data Collection and Recording

    Stability testing involves collecting and recording various data points, including temperature, humidity, and light exposure. USP <1191> requires that data be collected and recorded according to standard procedures, including:

  • Data logging

  • Data analysis

  • Reporting and documentation

    • These measures ensure accurate and reliable test results.

    Reporting and Documentation

    USP <1191> emphasizes the importance of reporting and documentation in stability testing. These aspects include:

  • Reporting test results

  • Documenting test procedures

  • Maintaining records of test data

    • These measures ensure transparency and accountability in stability testing.

    Persuasive Testing

    While this is not a part of the standard it can be helpful to use persuasive language when explaining why performing the tests are important. Heres an example:

    Conducting USP <1191> testing is crucial for ensuring product safety and efficacy. By investing in these tests, you can:

  • Enhance customer confidence and trust

  • Improve market positioning and competitiveness

  • Increase brand reputation and credibility

  • Reduce risk of product recalls and regulatory actions

    • Dont wait until its too late invest in USP <1191> testing today and ensure the quality, safety, and efficacy of your compounded preparations.

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