EUROLAB
ph-eur-54-impurities-in-radiopharmaceutical-preparations
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 UseUSP <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. 5.4: Impurities in Radiopharmaceutical Preparations Laboratory Testing Service by Eurolab

Ph. Eur. 5.4: Impurities in Radiopharmaceutical Preparations is a European Pharmacopoeia standard that governs the testing of impurities in radiopharmaceutical preparations. This standard is published by the European Directorate for the Quality of Medicines HealthCare (EDQM) and is intended to ensure the safety, quality, and efficacy of radiopharmaceuticals.

Legal and Regulatory Framework

The legal and regulatory framework surrounding Ph. Eur. 5.4: Impurities in Radiopharmaceutical Preparations testing is governed by various international and national standards, including:

  • ISO 11135 (2014): Sterilization of Medical Devices using Ionizing Radiation

  • ASTM E2230-15 (2015): Standard Practice for Use of Additive Manufacturing with Metals

  • EN ISO 13485:2016: Medical devices -- Quality management systems -- Requirements for regulatory purposes

  • TSE (Turkish Standards Institution) standards

    • International and National Standards

    The following international and national standards apply to Ph. Eur. 5.4: Impurities in Radiopharmaceutical Preparations testing:

  • ISO/TS 11135-1:2013: Sterilization of medical devices using ionizing radiation -- Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices involving ionizing radiation

  • EN 14332 (2006): Radiopharmaceutical preparations -- Quality control

  • TSE ISO 11135-1:2013: Sterilizasyon cihazları için ışınlama radyasyonu ile sterilizasyon - 1. Bölüm: İyonizing ışınlama radyasyonu kullanarak sterilizasyon işlemi için sterilizasyon prosesi geliştirme, doğrulama ve normal kontrol koşullarını belirler

    • Standard Development Organizations

    The standard development organizations that govern Ph. Eur. 5.4: Impurities in Radiopharmaceutical Preparations testing include:

  • European Directorate for the Quality of Medicines HealthCare (EDQM)

  • International Organization for Standardization (ISO)

  • American Society for Testing and Materials (ASTM)

    • Standard Evolution

    Standards evolve over time to reflect changes in technology, regulations, and industry practices. Eurolab stays up-to-date with the latest standards and updates to ensure that our testing services meet the evolving needs of the industry.

    Standard Compliance Requirements

    Compliance with Ph. Eur. 5.4: Impurities in Radiopharmaceutical Preparations requires:

  • Use of certified equipment and materials

  • Adherence to established procedures and protocols

  • Regular calibration and maintenance of equipment

  • Training and certification of personnel

    • Industries and Sectors

    The following industries and sectors require Ph. Eur. 5.4: Impurities in Radiopharmaceutical Preparations testing:

  • Pharmaceutical industry

  • Biotechnology industry

  • Medical device industry

  • Research institutions

    • Risk Factors and Safety Implications

    Failure to conduct Ph. Eur. 5.4: Impurities in Radiopharmaceutical Preparations testing can result in:

  • Inaccurate or unreliable results

  • Product contamination or adulteration

  • Patient harm or injury

  • Regulatory non-compliance

    • Quality Assurance and Control

    Eurolabs quality assurance and control measures for Ph. Eur. 5.4: Impurities in Radiopharmaceutical Preparations testing include:

  • Regular calibration and maintenance of equipment

  • Use of certified materials and reagents

  • Adherence to established procedures and protocols

  • Training and certification of personnel

    • Step-by-Step Explanation

    Ph. Eur. 5.4: Impurities in Radiopharmaceutical Preparations testing involves the following steps:

    1. Sample collection and preparation

    2. Equipment setup and calibration

    3. Testing parameters and conditions

    4. Measurement and analysis methods

    5. Data collection and recording

    Testing Equipment and Instruments

    Eurolab uses state-of-the-art equipment and instruments for Ph. Eur. 5.4: Impurities in Radiopharmaceutical Preparations testing, including:

  • High-performance liquid chromatography (HPLC) systems

  • Mass spectrometry (MS) systems

  • Gamma counters

    • Testing Environment Requirements

    The following environmental conditions are required for Ph. Eur. 5.4: Impurities in Radiopharmaceutical Preparations testing:

  • Temperature range: 20C to 25C

  • Humidity level: 40 to 60

  • Lighting level: dim or fluorescent

    • Measurement and Analysis Methods

    Eurolab uses established measurement and analysis methods for Ph. Eur. 5.4: Impurities in Radiopharmaceutical Preparations testing, including:

  • HPLC-MS/MS

  • GC-MS/MS

    • Data Collection and Recording

    Data collection and recording are critical steps in Ph. Eur. 5.4: Impurities in Radiopharmaceutical Preparations testing. Eurolab uses specialized software to collect and record data, including:

  • Chromatography data system (CDS)

  • Laboratory information management system (LIMS)

    • Test Conditions and Methodology

    Eurolabs test conditions and methodology for Ph. Eur. 5.4: Impurities in Radiopharmaceutical Preparations testing include:

  • Use of certified equipment and materials

  • Adherence to established procedures and protocols

  • Regular calibration and maintenance of equipment

    • ... (remainder of the text will be provided if needed)

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