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usp-891-nuclear-magnetic-resonance-nmr-for-structural-elucidation
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 <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 <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 <891>: Nuclear Magnetic Resonance (NMR) for Structural Elucidation Laboratory Testing Service Provided by Eurolab

Standard-Related Information

The United States Pharmacopeia (USP) is a non-profit organization that develops and publishes standards for the pharmaceutical industry. USP <891> is one of these standards, which outlines the requirements for Nuclear Magnetic Resonance (NMR) spectroscopy for structural elucidation testing.

Relevant Standards

  • ISO 17294-1:2006 - Nuclear magnetic resonance (NMR) data processing

  • ASTM E2940-12 - Standard Practice for Nuclear Magnetic Resonance Spectroscopy

  • EN 13609-2:2015 - Chemical analytical and chemical testing methods for the analysis of pharmaceuticals

  • TSE L101/4:2016 - Nuclear magnetic resonance (NMR) spectroscopy

    • Legal and Regulatory Framework

    The USP <891> standard is a regulatory requirement in many countries, including the United States. Compliance with this standard is essential to ensure that pharmaceutical products meet the required quality standards.

    Standard Development Organizations

  • International Organization for Standardization (ISO)

  • American Society for Testing and Materials (ASTM)

  • European Committee for Standardization (CEN)

    • These organizations develop and publish standards for various industries, including pharmaceuticals. Their standards are widely adopted and recognized globally.

    International and National Standards

    USP <891> is based on the ISO 17294-1 standard, which provides guidelines for NMR data processing. Other national and international standards may also apply to this testing service.

    Standard Compliance Requirements

    Compliance with USP <891> requires that laboratories have the necessary equipment, expertise, and quality control procedures in place to ensure accurate and reliable results.

    Industries and Sectors Requiring This Testing

    Pharmaceutical companies, research institutions, and regulatory agencies require NMR spectroscopy for structural elucidation testing as part of their quality control programs.

    Consequences of Not Performing This Test

    Failure to conduct USP <891> testing can result in non-compliance with regulatory requirements, product recalls, and reputational damage.

    Business and Technical Reasons for Conducting USP <891> Testing

    This testing is necessary to ensure the quality and purity of pharmaceutical products. It provides valuable information about the molecular structure of substances, which is essential for their identification and characterization.

    Risk Factors and Safety Implications

    Poorly designed or executed NMR spectroscopy experiments can result in inaccurate or unreliable results, which may compromise product safety and efficacy.

    Quality Assurance and Quality Control Aspects

    Laboratories conducting USP <891> testing must have robust quality control procedures in place to ensure accurate and reliable results. This includes calibration and validation of equipment, sample preparation, and data analysis.

    Competitive Advantages of Having This Testing Performed

    Companies that conduct USP <891> testing demonstrate their commitment to quality and compliance with regulatory requirements. This can enhance customer trust and confidence in their products.

    Cost-Benefit Analysis of Performing This Test

    The costs associated with conducting USP <891> testing are offset by the benefits of improved product safety, efficacy, and regulatory compliance.

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    Standard Requirements and Needs

    Why This Specific Test is Needed and Required

    NMR spectroscopy for structural elucidation testing is essential to ensure that pharmaceutical products meet quality standards. It provides valuable information about molecular structure, which is critical for product identification and characterization.

    Business and Technical Reasons for Conducting USP <891> Testing

    This testing is necessary to ensure the quality and purity of pharmaceutical products. It provides valuable information about the molecular structure of substances, which is essential for their identification and characterization.

    Consequences of Not Performing This Test

    Failure to conduct USP <891> testing can result in non-compliance with regulatory requirements, product recalls, and reputational damage.

    Industries and Sectors Requiring This Testing

    Pharmaceutical companies, research institutions, and regulatory agencies require NMR spectroscopy for structural elucidation testing as part of their quality control programs.

    Risk Factors and Safety Implications

    Poorly designed or executed NMR spectroscopy experiments can result in inaccurate or unreliable results, which may compromise product safety and efficacy.

    Quality Assurance and Quality Control Aspects

    Laboratories conducting USP <891> testing must have robust quality control procedures in place to ensure accurate and reliable results. This includes calibration and validation of equipment, sample preparation, and data analysis.

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    Test Conditions and Methodology

    Testing Equipment and Instruments Used

  • NMR spectrometer

  • Computer system for data processing and analysis

    • Testing Environment Requirements

  • Temperature: 20 5C

  • Humidity: 50 10

    • Sample Preparation Procedures

  • Sample preparation is critical to ensure accurate results. Samples must be carefully prepared to minimize contamination and degradation.

    • Data Analysis

  • Data analysis involves the interpretation of NMR spectra to identify molecular structure and composition.

    • ---

    Calibration and Validation of Equipment

  • Calibration of equipment is essential to ensure accurate results.

  • Validation of equipment is required to demonstrate its performance and reliability.

    • Data Processing and Analysis

  • Data processing involves the conversion of raw NMR data into a format suitable for analysis.

  • Data analysis involves the interpretation of NMR spectra to identify molecular structure and composition.

    • ---

    Quality Control Procedures

  • Laboratories conducting USP <891> testing must have robust quality control procedures in place to ensure accurate and reliable results.

  • This includes calibration and validation of equipment, sample preparation, and data analysis.

    • Training and Experience

  • Personnel conducting USP <891> testing must be properly trained and experienced in NMR spectroscopy.

    • ---

    Documentation and Record Keeping

  • Laboratories conducting USP <891> testing must maintain accurate records of all experiments, including sample preparation, data collection, and analysis.

  • Documentation must include the results of calibration and validation procedures.

    • ---

    Conclusion

    USP <891> is a critical standard for NMR spectroscopy for structural elucidation testing. Compliance with this standard requires that laboratories have the necessary equipment, expertise, and quality control procedures in place to ensure accurate and reliable results.

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