EUROLAB
usp-161-transdermal-delivery-systems-and-impurity-control
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 <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

USP <161>: Transdermal Delivery Systems and Impurity Control Laboratory Testing Service Provided by Eurolab

Introduction

Transdermal delivery systems are a crucial aspect of modern pharmaceuticals, enabling the controlled release of active ingredients through the skin to achieve therapeutic effects. However, ensuring the quality, safety, and efficacy of these systems is paramount. The United States Pharmacopeia (USP) <161> guidelines provide a comprehensive framework for testing transdermal delivery systems and controlling impurities. Eurolab, a leading laboratory testing services provider, offers expert support in meeting these standards.

Standard-Related Information

The USP <161> guidelines are developed by the USP Committee of Experts to ensure consistency and reliability in transdermal delivery system testing. This standard is based on international best practices, including ISO 10993 (Biological Evaluation), ASTM E2780 (Transdermal Delivery Systems), and EN ISO 10993-10 (Biocompatibility).

International and National Standards

The following standards apply to USP <161>:

  • ISO 9001: Quality Management System

  • ASTM E2780: Transdermal Delivery Systems

  • EN ISO 10993-10: Biocompatibility of Medical Devices

  • TSE (Turkish Standard Institution) requirements for transdermal delivery systems

    • Standard Compliance Requirements

    Transdermal delivery system manufacturers must comply with USP <161> to ensure product safety, efficacy, and quality. This includes:

    1. Testing for impurities and contaminants

    2. Evaluating the biocompatibility of materials used in transdermal delivery systems

    3. Ensuring consistency and reliability in manufacturing processes

    Industry-Specific Requirements

    Transdermal delivery system manufacturers must adhere to specific regulations in different industries, such as:

  • Pharmaceutical: USP <161> guidelines for transdermal delivery systems

  • Medical Devices: EN ISO 10993-10 (Biocompatibility of Medical Devices)

  • Cosmetics: EU cosmetics regulation (EC) No. 1223/2009

    • Standard Development Organizations

    The USP Committee of Experts, comprising experts from the pharmaceutical industry, regulatory agencies, and academia, develops standards for transdermal delivery systems.

    Evolution of Standards

    Standards evolve as new technologies emerge and research reveals new insights into material safety and efficacy. Regular updates ensure that testing methods remain relevant and effective.

    Standard Numbers and Scope

  • USP <161>: Transdermal Delivery Systems

  • ISO 10993: Biological Evaluation

  • ASTM E2780: Transdermal Delivery Systems

  • EN ISO 10993-10: Biocompatibility of Medical Devices

    • Test Conditions and Methodology

    The testing process involves:

    1. Sample preparation: Collecting, preparing, and storing transdermal delivery system samples.

    2. Testing equipment and instruments: Using state-of-the-art equipment to analyze samples.

    3. Environmental conditions: Maintaining controlled temperature (20-25C), humidity (30-60), and pressure conditions.

    4. Measurement and analysis methods: Utilizing validated analytical techniques for impurity control, biocompatibility evaluation, and material characterization.

    Testing Parameters and Conditions

    The following parameters are tested in transdermal delivery systems:

  • Impurities (heavy metals, residues, etc.)

  • Biocompatibility (skin irritation, cytotoxicity, etc.)

  • Material properties (mechanical strength, thermal stability, etc.)

    • Quality Control Measures during Testing

    Eurolab implements rigorous quality control measures to ensure accuracy and reliability in testing results.

    Data Collection and Recording Procedures

    Test data is collected using validated analytical techniques, and results are recorded in a standardized format for easy interpretation.

    Reporting Standards and Formats

    Test reports are provided in a clear, concise manner, detailing the test parameters, methods, and results.

    Why this Test Should be Performed

    Performing USP <161> testing provides numerous benefits, including:

  • Ensuring product safety and efficacy

  • Compliance with international regulations

  • Enhanced customer confidence and trust

  • Market positioning and competitive advantage

    • Why Eurolab Should Provide this Service

    Eurolab offers expert support in USP <161> testing due to its:

  • State-of-the-art equipment and facilities

  • Qualified and certified personnel

  • Accreditation and certification details

  • International recognition and partnerships

  • Quality management systems and procedures

  • Customer service and support capabilities

    • Conclusion

    USP <161>: Transdermal Delivery Systems and Impurity Control laboratory testing is a critical aspect of ensuring product safety, efficacy, and quality. Eurolab provides expert support in meeting these standards, offering comprehensive services that cater to the needs of transdermal delivery system manufacturers.

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    APPENDIX: EUROLABS QUALIFICATION AND ACCREDITATION DETAILS

    Eurolab holds accreditation from ISO 9001:2015 (Quality Management System) and operates under a strict quality management system. Our personnel are qualified, trained, and certified to perform USP <161> testing.

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