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usp-1091-impurity-isolation-and-characterization-techniques
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 <1099>: Acceptable Analytical Performance CriteriaUSP <1121>: Bulk Pharmaceutical Chemicals and Impurity HandlingUSP <1151>: Pharmaceutical Dosage Forms and Impurity ConsiderationUSP <1191>: Stability Testing of Compounded PreparationsUSP <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

Comprehensive Guide to USP <1091>: Impurity Isolation and Characterization Techniques Laboratory Testing Service Provided by Eurolab

USP <1091> is a comprehensive standard that outlines the requirements for impurity isolation and characterization techniques in pharmaceutical and related industries. This standard is published by the United States Pharmacopeia (USP) and is widely adopted globally.

Legal and Regulatory Framework

The legal and regulatory framework surrounding USP <1091> is governed by various international, national, and industry-specific standards. Some of the key standards include:

  • ISO 14644: Cleanrooms and associated controlled environments

  • ASTM E2500-13: Standard Guide for Establishing a Quality Management System in Testing Laboratories

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

  • TSE (Turkish Standards Institution) and other national standards

    • International and National Standards

    The following international and national standards apply to USP <1091>:

  • ISO 9001: Quality management systems - Requirements

  • ASTM E1505-18: Standard Guide for Development of a Quality Management System in Testing Laboratories

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

    • Standard Development Organizations

    Standard development organizations (SDOs) play a crucial role in developing and maintaining standards. Some key SDOs include:

  • International Organization for Standardization (ISO)

  • American Society for Testing and Materials (ASTM)

  • European Committee for Standardization (CEN)

    • Evolution of Standards

    Standards evolve and get updated to reflect changes in technology, regulations, and industry practices. The following is an overview of the standard development process:

    1. Proposal: An SDO proposes a new or revised standard.

    2. Drafting: A drafting committee develops the standard.

    3. Review: Stakeholders review and comment on the draft.

    4. Approval: The final standard is approved by the SDO.

    Standard Numbers and Scope

    The following are some key standard numbers and their scope:

  • USP <1091>: Impurity Isolation and Characterization Techniques

  • ISO 14644-7: Cleanrooms and associated controlled environments - Part 7: Classification of air cleanliness in cleanrooms and clean zones

  • ASTM E2500-13: Standard Guide for Establishing a Quality Management System in Testing Laboratories

    • Compliance Requirements

    Compliance with these standards is mandatory for various industries, including:

  • Pharmaceutical and related industries

  • Food and beverage industries

  • Biotechnology and biopharmaceutical industries

  • Medical device manufacturers

    • Non-compliance can result in regulatory fines, product recalls, and damage to reputation.

    Why This Test is Needed and Required

    USP <1091> testing is required to ensure the safety and efficacy of pharmaceutical products. Impurities can affect product stability, shelf life, and patient safety. This test is essential for:

  • Ensuring product quality

  • Meeting regulatory requirements

  • Protecting public health

    • Business and Technical Reasons for Conducting USP <1091> Testing

    Conducting USP <1091> testing has several business and technical benefits, including:

  • Reduced risk of product recalls

  • Compliance with regulations

  • Improved product safety and efficacy

  • Enhanced customer confidence

  • Increased market access

    • Consequences of Not Performing This Test

    Not performing USP <1091> testing can result in:

  • Product recalls

  • Regulatory fines

  • Damage to reputation

  • Loss of customer trust

    • Industries and Sectors Requiring USP <1091> Testing

    USP <1091> testing is required for various industries, including:

  • Pharmaceutical manufacturers

  • Biotechnology companies

  • Medical device manufacturers

  • Food and beverage manufacturers

    • Risk Factors and Safety Implications

    Impurities can have serious safety implications, including:

  • Adverse reactions in patients

  • Product instability

  • Shelf life reduction

    • Quality Assurance and Control Aspects

    USP <1091> testing is an essential part of quality assurance and control. This test ensures that products meet regulatory requirements and are safe for consumption.

    Contributions to Product Safety and Reliability

    USP <1091> testing contributes significantly to product safety and reliability by:

  • Ensuring impurity levels meet regulatory limits

  • Detecting potential contaminants

  • Improving product stability and shelf life

    • Step-by-Step Explanation of the Test

    The following is a step-by-step explanation of the USP <1091> test:

    1. Sample preparation: The sample is prepared according to standard procedures.

    2. Instrumentation: Various instruments, including GC-MS, HPLC, and ICP-MS, are used for analysis.

    3. Testing parameters: Parameters such as retention time, peak area, and wavelength are measured.

    4. Data analysis: Results are analyzed using software and compared with regulatory limits.

    Equipment Used

    The following equipment is used for USP <1091> testing:

  • Gas chromatography-mass spectrometry (GC-MS)

  • High-performance liquid chromatography (HPLC)

  • Inductively coupled plasma mass spectrometry (ICP-MS)

    • Conclusion

    In conclusion, USP <1091> is a comprehensive standard that outlines the requirements for impurity isolation and characterization techniques in pharmaceutical and related industries. This test is essential for ensuring product safety and efficacy, meeting regulatory requirements, and protecting public health.

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    Please note that this is not a complete document but rather a summary of the main points to give you an idea of what a comprehensive guide might look like.

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