EUROLAB
ph-eur-2238-thin-layer-chromatography-for-impurities
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. 2.2.46: 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 ImpuritiesUSP <941>: Characterization of Impurity Solubility and pKaWHO TRS 970 Annex 2: Impurity Control in Medicines

Eurolabs Ph. Eur. 2.2.38: Thin-Layer Chromatography for Impurities Laboratory Testing Service

Ph. Eur. 2.2.38: Thin-Layer Chromatography for Impurities is a laboratory testing service that adheres to the guidelines and regulations set forth by the European Pharmacopoeia (Ph. Eur.). The standard is designed to ensure the quality and purity of pharmaceutical products, particularly in the context of impurity detection.

Relevant Standards

The following standards are relevant to Ph. Eur. 2.2.38: Thin-Layer Chromatography for Impurities:

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

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

  • Ph. Eur. 2.2.38: Thin-layer chromatography (TLC) for impurities

    • Legal and Regulatory Framework

    The regulatory framework surrounding Ph. Eur. 2.2.38: Thin-Layer Chromatography for Impurities is primarily governed by the European Unions (EU) pharmaceutical regulations, including:

  • EU Directive 2001/82/EC: Animal health products

  • EU Directive 2001/83/EC: Medicinal products for human use

    • Standard Development Organizations

    The standard development organizations involved in Ph. Eur. 2.2.38: Thin-Layer Chromatography for Impurities include:

  • European Pharmacopoeia Commission (Ph. Eur.)

  • International Organization for Standardization (ISO)

  • Comité Européen de Normalisation (CEN)

    • Standard Evolution and Update

    Standards are continually evolving to reflect advancements in technology, scientific understanding, and regulatory requirements. Regular updates ensure that standards remain relevant and effective.

    Standard Compliance Requirements

    Pharmaceutical manufacturers and suppliers must comply with Ph. Eur. 2.2.38: Thin-Layer Chromatography for Impurities as a requirement for product registration and market access.

    Industry-Specific Examples and Case Studies

  • Pharmaceutical industry: A manufacturer of active pharmaceutical ingredients (APIs) must conduct regular impurity testing using Ph. Eur. 2.2.38: Thin-Layer Chromatography for Impurities to ensure compliance with regulatory requirements.

  • Cosmetics industry: A cosmetic manufacturer must test their products for impurities, including heavy metals and other contaminants, in accordance with Ph. Eur. 2.2.38: Thin-Layer Chromatography for Impurities.

    • Why This Test Should Be Performed

    Ph. Eur. 2.2.38: Thin-Layer Chromatography for Impurities testing is essential to ensure product quality, safety, and efficacy. Non-compliance with regulatory requirements can result in:

  • Product recalls

  • Loss of market access

  • Regulatory penalties

  • Food industry: A food manufacturer must test their products for impurities, including heavy metals and other contaminants, in accordance with Ph. Eur. 2.2.38: Thin-Layer Chromatography for Impurities.

  • Chemical industry: A chemical supplier must conduct regular impurity testing using Ph. Eur. 2.2.38: Thin-Layer Chromatography for Impurities to ensure compliance with regulatory requirements.

    • Why This Test is Needed and Required

    Ph. Eur. 2.2.38: Thin-Layer Chromatography for Impurities testing is required by regulatory authorities as a means of ensuring product quality, safety, and efficacy.

    Business and Technical Reasons for Conducting the Test

    The business and technical reasons for conducting Ph. Eur. 2.2.38: Thin-Layer Chromatography for Impurities testing include:

  • Product safety

  • Regulatory compliance

  • Quality assurance

  • Cost savings

  • Competitive advantages

    • Consequences of Not Performing the Test

    Non-compliance with regulatory requirements can result in:

  • Product recalls

  • Loss of market access

  • Regulatory penalties

    • Industries and Sectors Requiring This Testing

    The following industries and sectors require Ph. Eur. 2.2.38: Thin-Layer Chromatography for Impurities testing:

  • Pharmaceutical industry

  • Cosmetics industry

  • Food industry

  • Chemical industry

    • Quality Assurance and Quality Control Aspects

    Ph. Eur. 2.2.38: Thin-Layer Chromatography for Impurities testing is an essential component of a laboratorys quality assurance and quality control program.

    Ph. Eur. 2.2.38: Thin-Layer Chromatography for Impurities testing ensures:

  • Product purity

  • Regulatory compliance

  • Quality assurance

    • Test Methodology and Procedure

    The test methodology and procedure for Ph. Eur. 2.2.38: Thin-Layer Chromatography for Impurities involve the following steps:

    1. Sample preparation

    2. TLC analysis

    3. Detection and quantification

    Instrumentation and Equipment

    The instrumentation and equipment required for Ph. Eur. 2.2.38: Thin-Layer Chromatography for Impurities testing include:

  • TLC plates

  • Developing solvents

  • Detector systems

    • Sample Preparation

    Sample preparation involves the following steps:

    1. Homogenization

    2. Extraction

    3. Cleaning

    TLC Analysis

    TLC analysis involves the following steps:

    1. Plate loading

    2. Development

    3. Detection and quantification

    Detector Systems

    Detector systems used for Ph. Eur. 2.2.38: Thin-Layer Chromatography for Impurities testing include:

  • UV-Vis detectors

  • Fluorescence detectors

    • Ph. Eur. 2.2.38: Thin-Layer Chromatography for Impurities testing ensures:

  • Product purity

  • Regulatory compliance

  • Quality assurance

    • Interpretation of Results

    The interpretation of results for Ph. Eur. 2.2.38: Thin-Layer Chromatography for Impurities involves the following steps:

    1. Data analysis

    2. Result reporting

    3. Certificate issuance

    Data Analysis

    Data analysis involves the following steps:

    1. Peak identification

    2. Quantification

    3. Limit of detection (LOD) determination

    Result Reporting

    Result reporting involves the following steps:

    1. Reporting format

    2. Data presentation

    3. Certificate issuance

    Certificate Issuance

    Certificate issuance involves the following steps:

    1. Certification body involvement

    2. Certificate preparation

    3. Certificate issuance

    Ph. Eur. 2.2.38: Thin-Layer Chromatography for Impurities testing ensures:

  • Product purity

  • Regulatory compliance

  • Quality assurance

    • Conclusion

    Ph. Eur. 2.2.38: Thin-Layer Chromatography for Impurities is a laboratory testing service that adheres to the guidelines and regulations set forth by the European Pharmacopoeia (Ph. Eur.). The standard ensures product quality, safety, and efficacy while ensuring regulatory compliance.

    References

  • European Pharmacopoeia Commission (Ph. Eur.): Thin-layer chromatography (TLC) for impurities

  • International Organization for Standardization (ISO): General requirements for the competence of testing and calibration laboratories

  • Comité Européen de Normalisation (CEN): General requirements for the competence of testing and calibration laboratories

    • Appendix

    The following documents are provided as appendices:

  • Ph. Eur. 2.2.38: Thin-layer chromatography (TLC) for impurities

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

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

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