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usp-941-characterization-of-impurity-solubility-and-pka
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 <891>: Nuclear Magnetic Resonance (NMR) for Structural ElucidationUSP <905>: Content Uniformity Related to ImpuritiesUSP <905>: Uniformity of Dosage Units Affected by ImpuritiesWHO TRS 970 Annex 2: Impurity Control in Medicines

USP <941>: Characterization of Impurity Solubility and pKa Laboratory Testing Service Provided by Eurolab

The United States Pharmacopeia (USP) is a non-profit organization that sets standards for the quality, purity, and identity of pharmaceuticals, dietary supplements, and other healthcare products. USP <941> provides guidelines for characterizing impurity solubility and pKa, which are critical parameters in ensuring the safety and efficacy of medicinal products.

Relevant Standards

  • ISO 10993-5: Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity

  • ASTM E2557-07: Standard Guide for Characterization of Impurities in Pharmaceuticals by HPLC-UV Detection

  • EN 13726-1: In vitro evaluation of implantable materials

  • TSE (Turkish Standards Institution) ISO/TS 17134:2018: Medical devices - Risk management - Requirements for application of risk management to medical devices

    • Legal and Regulatory Framework

    The USP <941> is a compendial standard that sets forth requirements for the characterization of impurity solubility and pKa. Compliance with this standard is mandatory for pharmaceutical manufacturers, suppliers, and regulatory agencies.

    Standard Development Organizations (SDOs)

  • International Organization for Standardization (ISO)

  • American Society for Testing and Materials (ASTM)

  • European Committee for Standardization (CEN)

  • Turkish Standards Institution (TSE)

    • These SDOs develop and maintain standards that ensure the quality, safety, and efficacy of medicinal products.

    Evolution of Standards

    Standards evolve over time to address new scientific knowledge, technological advancements, and regulatory requirements. The USP <941> has undergone several revisions since its initial publication in 2003.

    Standard Numbers and Scope

  • ISO 10993-5:2014

  • ASTM E2557-07 (withdrawn)

  • EN 13726-1:2006A1:2010

  • TSE ISO/TS 17134:2018

    • These standards provide guidelines for characterizing impurity solubility and pKa, which are essential parameters in ensuring the safety and efficacy of medicinal products.

    Standard Compliance Requirements

    Pharmaceutical manufacturers, suppliers, and regulatory agencies must comply with these standards to ensure the quality, purity, and identity of medicinal products.

    Standard-Related Information Table

    Standard Number Title Scope

    --- --- ---

    ISO 10993-5:2014 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity Specifies tests for in vitro cytotoxicity of implantable materials

    ASTM E2557-07 (withdrawn) Standard Guide for Characterization of Impurities in Pharmaceuticals by HPLC-UV Detection Provides guidelines for characterizing impurities in pharmaceuticals using HPLC-UV detection

    EN 13726-1:2006A1:2010 In vitro evaluation of implantable materials Specifies tests for evaluating the biocompatibility of implantable materials

    TSE ISO/TS 17134:2018 Medical devices - Risk management - Requirements for application of risk management to medical devices Specifies requirements for applying risk management to medical devices

    Standard-Related Information Figure

    Insert a figure illustrating the standard-related information

    ---

    Why this Specific Test is Needed and Required

    The characterization of impurity solubility and pKa is essential in ensuring the safety and efficacy of medicinal products. Impurities can affect the quality, purity, and identity of pharmaceuticals, leading to adverse reactions, reduced efficacy, or even product failure.

    Business and Technical Reasons for Conducting USP <941>

    Pharmaceutical manufacturers must comply with regulatory requirements, industry standards, and customer specifications to ensure the quality, purity, and identity of medicinal products. The characterization of impurity solubility and pKa is critical in ensuring the safety and efficacy of pharmaceuticals.

    Consequences of Not Performing this Test

    Failure to perform USP <941> can result in:

  • Product failure

  • Reduced efficacy or potency

  • Adverse reactions or toxicity

  • Regulatory non-compliance

  • Loss of customer confidence and reputation

    • Industries and Sectors that Require this Testing

    Pharmaceutical manufacturers, suppliers, and regulatory agencies must comply with USP <941> to ensure the quality, purity, and identity of medicinal products.

    Risk Factors and Safety Implications

    Impurities can affect the quality, purity, and identity of pharmaceuticals, leading to adverse reactions, reduced efficacy, or even product failure. The characterization of impurity solubility and pKa is essential in ensuring the safety and efficacy of medicinal products.

    USP <941> Table

    Parameter Importance

    --- ---

    Impurity solubility Critical for ensuring the quality and purity of pharmaceuticals

    pKa Essential for determining the ionization state of impurities

    ---

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