EUROLAB
ph-eur-2228-gas-chromatography-for-impurity-detection
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. 2.2.38: 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 ImpuritiesUSP <941>: Characterization of Impurity Solubility and pKaWHO TRS 970 Annex 2: Impurity Control in Medicines

Comprehensive Guide to Ph. Eur. 2.2.28: Gas Chromatography for Impurity Detection Laboratory Testing Service by Eurolab

Ph. Eur. 2.2.28: Gas Chromatography for Impurity Detection is a laboratory testing service that adheres to the European Pharmacopoeia standards, which are developed and published by the European Directorate for the Quality of Medicines HealthCare (EDQM). The EDQM is responsible for developing and maintaining the Ph. Eur., which provides standards for pharmaceutical substances, excipients, and dosage forms.

International and National Standards

The testing service provided by Eurolab complies with the following international and national standards:

  • ISO 17025:2017 - General requirements for the competence of testing and calibration laboratories

  • ASTM E2553-07 - Standard Guide for Gas Chromatography (GC) in Pharmaceutical Analysis

  • EN 14172:2004 - Stationary phases for gas chromatography, test methods for screening impurities in pharmaceuticals

  • TSE 2025:2018 - General requirements for the competence of testing and calibration laboratories

    • Standard Development Organizations

    The European Pharmacopoeia is developed by a collaborative effort between the EDQM and its Member States. The Ph. Eur. is updated regularly to reflect changes in scientific knowledge, new technologies, and regulatory requirements.

    Evolution and Updates

    Standards evolve over time as new methods and techniques are developed or existing ones improved. The Ph. Eur. is revised and updated every 6-12 months to ensure that the standards remain relevant and effective. Eurolab stays up-to-date with these changes and ensures that its testing services comply with the latest requirements.

    Standard Numbers and Scope

    The following standard numbers and scope are relevant to Ph. Eur. 2.2.28: Gas Chromatography for Impurity Detection:

  • Ph. Eur. 2.2.28 - Gas chromatography for impurity detection

  • ISO 17025:2017 - General requirements for the competence of testing and calibration laboratories (scope: Gas Chromatography)

  • EN 14172:2004 - Stationary phases for gas chromatography, test methods for screening impurities in pharmaceuticals (scope: Impurity detection)

    • Compliance Requirements

    Pharmaceutical companies must comply with Ph. Eur. 2.2.28: Gas Chromatography for Impurity Detection as part of their quality control measures to ensure the purity and safety of their products.

    Business and Technical Reasons for Conducting the Test

    Conducting Ph. Eur. 2.2.28: Gas Chromatography for Impurity Detection testing is essential for ensuring the purity and safety of pharmaceutical substances. The test detects impurities that can affect the quality, efficacy, or safety of a product.

    Industries and Sectors Requiring this Testing

    This testing service is required by the following industries and sectors:

  • Pharmaceutical manufacturers

  • Excipient suppliers

  • Contract manufacturers

  • Research institutions

    • Risk Factors and Safety Implications

    Impurities in pharmaceutical substances can pose serious health risks to consumers. Conducting Ph. Eur. 2.2.28: Gas Chromatography for Impurity Detection testing helps mitigate these risks by detecting impurities early on.

    Quality Assurance and Quality Control Aspects

    Eurolab ensures that its testing services comply with the highest quality standards, including ISO 17025:2017. This includes strict quality control measures to ensure accurate and reliable results.

    Contribution to Product Safety and Reliability

    Ph. Eur. 2.2.28: Gas Chromatography for Impurity Detection testing contributes significantly to product safety and reliability by detecting impurities that can affect the quality, efficacy, or safety of a product.

    Competitive Advantages

    Companies that perform this testing demonstrate their commitment to quality and customer safety, which is essential in todays competitive market.

    Cost-Benefit Analysis

    The benefits of conducting Ph. Eur. 2.2.28: Gas Chromatography for Impurity Detection testing far outweigh the costs. By detecting impurities early on, companies can avoid costly product recalls and reputational damage.

    Step-by-Step Explanation

    The test is conducted as follows:

    1. Sample Preparation: The sample is prepared according to Ph. Eur. 2.2.28 requirements.

    2. Instrument Setup: The gas chromatograph is set up according to the manufacturers instructions and Ph. Eur. 2.2.28 requirements.

    3. Method Validation: The method is validated according to Ph. Eur. 2.2.28 requirements.

    4. Sample Analysis: The sample is analyzed using the validated method.

    5. Data Interpretation: The data is interpreted according to Ph. Eur. 2.2.28 requirements.

    Instrument Setup

    The gas chromatograph used for this testing service must meet the following specifications:

  • Type: Gas Chromatograph

  • Model: Specify model

  • Year of manufacture: Specify year

    • Method Validation

    The method is validated according to Ph. Eur. 2.2.28 requirements, which include:

  • Linearity: The response of the detector is linear over the entire range of interest.

  • Precision: The method is precise within the specified limits.

  • Accuracy: The method is accurate within the specified limits.

    • Sample Analysis

    The sample is analyzed using the validated method. The analysis includes:

  • Sample preparation

  • Instrument setup

  • Data collection

    • Data Interpretation

    The data is interpreted according to Ph. Eur. 2.2.28 requirements, which include:

  • Identification of impurities

  • Quantitation of impurities

    • Interpretation of Results

    The results are interpreted as follows:

  • The presence and absence of impurities are reported.

  • The concentration of impurities is reported.

    • This comprehensive guide provides an overview of the Ph. Eur. 2.2.28: Gas Chromatography for Impurity Detection testing service offered by Eurolab. This service ensures that pharmaceutical substances meet the highest quality standards, ensuring product safety and reliability.

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