EUROLAB
usp-467-residual-solvents-testing-in-drug-substances
Pharmacopoeia-Based Assays BP Appendix VIII G: Total Ash in Herbal ProductsBP Appendix X: Identification Tests for Organic CompoundsBP Appendix XI C: Test for Water Insoluble MatterBP Appendix XII C: Uniformity of Weight TestBP Appendix XII F: Microbial Limits for Cosmetic PreparationsBP Appendix XII G: Total Aerobic Microbial Count in LiquidsBP Appendix XIV A: Refractive Index Measurement for OilsBP Appendix XIV C: Determination of pH Using ElectrodesBP Appendix XIV F: Assay of Sulphates by GravimetryBP Appendix XV B: Assay of Chloride in Raw MaterialsEP 2.2.2 UV-Visible Spectrophotometry AssayEP 2.2.20 Thin-Layer Chromatography Identity TestingEP 2.2.24 Absorption Spectrophotometry in the IR RegionEP 2.2.28 Gas Chromatography Method ValidationEP 2.2.3 Potentiometric pH MeasurementEP 2.2.32 Loss on Drying DeterminationEP 2.2.38 Differential Scanning Calorimetry AssayEP 2.4.4 Sulphated Ash for ExcipientsEP 2.4.8 Sulphated Ash AnalysisEP 2.5.12 Water Content (Karl Fischer Method)EP 2.6.12 Microbiological Examination of Non-Sterile ProductsEP 2.6.14 Microbiological Integrity Testing for PackagingEP 2.6.27 Bacterial Endotoxin Test Using Recombinant Factor CEP 2.9.1 Uniformity of Mass for Single-Dose PreparationsEP 2.9.3 Friability Testing for Uncoated TabletsEP 2.9.5 Hardness of Tablets MeasurementEP 2.9.7 Dissolution Testing for Gastro-resistant TabletsJP 3.01 Uniformity of Content in Powdered DrugsJP 3.03 Color and Clarity of Solution TestingJP 3.05 Osmolarity Testing in Ophthalmic SolutionsJP 4.01 Identification of Active Pharmaceutical IngredientsJP 4.04 Assay of Active Compounds Using UV MethodJP 4.05 Water Determination in Raw MaterialsJP 5.02 Determination of Peroxides in Lipophilic CompoundsJP 6.01 Test for Related Substances Using HPLCJP 6.03 Dissolution Test for Capsule Dosage FormsJP 6.04 Analysis of Pesticide Residues in Herbal MedicinesJP 6.05 Testing for Insoluble Matter in InjectionsJP 7.01 Test for pH in Oral SolutionsJP 7.02 Heavy Metal Test for Injection ProductsJP 8.02 Identity Testing Using IR SpectroscopyJP 8.03 Residual Solvents in APIsJP 9.01 Chromatographic Purity for Active SubstancesJP 9.04 Microbial Limits Test for OintmentsUSP <1029> Good Documentation Practices for TestingUSP <1030> Biological Assay for AntibodiesUSP <1032> Design and Conduct of Bioavailability StudiesUSP <1039> Reduced Sampling and Testing Plan JustificationUSP <1047> Testing for Biotechnological Protein ProductsUSP <1058> Analytical Instrument QualificationUSP <1062> Tablet and Capsule Weight Variation StudyUSP <1078> Good Manufacturing Practices for Bulk ExcipientsUSP <1079> Good Storage and Shipping Practices for Drug ProductsUSP <1088> Stability Testing of Drug SubstancesUSP <1092> Tablet Coating Performance TestingUSP <1106> Whole Package Integrity TestingUSP <1111> Microbiological Quality of Nonsterile ProductsUSP <1116> Control of Bioburden in Clean RoomsUSP <1117> Best Practices for Handling Hazardous CompoundsUSP <1163> Quality Assurance in Pharmaceutical CompoundingUSP <1181> Evaluation of Stability-Indicating MethodsUSP <1191> Stability Testing for Compounded PreparationsUSP <1216> Tablet Friability TestingUSP <121> Sterilization Assurance Level TestingUSP <1224> Transfer of Analytical ProceduresUSP <1225> Validation of Analytical ProceduresUSP <1226> Verification of Compendial ProceduresUSP <1227> Validation of Microbial Recovery from Pharm WatersUSP <1228> Depyrogenation Validation of EquipmentUSP <1231> Water for Pharmaceutical Purposes TestingUSP <231> Heavy Metals Limit Test for PharmaceuticalsUSP <232> Elemental Impurities – Limits in Finished ProductsUSP <233> Elemental Impurities – Procedures for AnalysisUSP <39-NF34> Identification Testing of Active Pharmaceutical IngredientsUSP <41> Weights and Balances Calibration CheckUSP <51> Antimicrobial Effectiveness Testing in Aqueous FormulationsUSP <61> Microbial Enumeration Tests for Raw MaterialsUSP <62> Tests for Specified MicroorganismsUSP <701> Disintegration Test for Uncoated TabletsUSP <711> Dissolution Testing for Immediate-Release Dosage FormsUSP <788> Particulate Matter in Injections AnalysisUSP <800> Hazardous Drugs Handling ValidationUSP <800> Surface Contamination Testing for Hazardous DrugsUSP <857> UV-Visible Spectroscopy System SuitabilityUSP <85> Bacterial Endotoxins Test for Parenteral PreparationsUSP <905> Uniformity of Dosage Units for CapsulesUSP <905> Uniformity of Dosage Units Testing

USP <467> Residual Solvents Testing in Drug Substances: Eurolabs Laboratory Testing Service

The testing of residual solvents in drug substances is governed by the United States Pharmacopeia (USP) <467> standard, which provides a framework for the identification and quantitation of residual solvents in pharmaceutical products. The USP <467> standard is based on international standards such as ISO 17025:2017 and ASTM E2609-19.

The regulatory framework surrounding this testing service includes guidelines from national and international authorities, including:

  • US FDA (United States Food and Drug Administration): Provides guidance on residual solvents in pharmaceutical products through the USP <467> standard.
  • EMA (European Medicines Agency): Requires residual solvent testing for all new active substances and excipients.
  • WHO (World Health Organization): Develops guidelines for residual solvent testing in pharmaceutical products.
  • Standards development organizations such as ASTM International and ISO/TC 210 provide guidance on test methods, specifications, and requirements. Standardization ensures consistency, reliability, and comparability of results across different laboratories.

    USP <467> Residual Solvents Testing in Drug Substances is essential for ensuring product safety and efficacy. The presence of residual solvents can pose risks to human health, including:

  • Toxicity: Some solvents have been linked to adverse effects such as neurological damage, reproductive issues, or cancer.
  • Mutagenicity: Certain solvents may cause genetic mutations, which can lead to cancer and other diseases.
  • Bioaccumulation: Solvents can accumulate in the body over time, potentially causing long-term health problems.
  • This testing service is required by various industries, including:

  • Pharmaceuticals: Compliance with USP <467> is necessary for pharmaceutical products to be approved and marketed.
  • Biotechnology: Residual solvent testing is essential for biotech products, which often involve complex processing conditions.
  • Cosmetics: Some solvents can cause skin irritation or allergic reactions; therefore, residual solvent testing is crucial.
  • The USP <467> test involves several steps:

    1. Sample preparation: A representative sample of the drug substance is prepared according to the standard.

    2. Instrumental analysis: The prepared sample is analyzed using gas chromatography or liquid chromatography coupled with mass spectrometry (GC-MS or LC-MS).

    3. Data interpretation: Results are evaluated against established limits and guidelines.

    Accurate testing requires:

  • Validated instrumentation: Equipment must be calibrated, validated, and maintained to ensure accuracy.
  • Proper sample handling: Samples must be stored, transported, and analyzed according to the standard.
  • Quality control measures: The laboratory must implement quality control procedures to ensure data integrity.
  • The test report should include:

    1. Test results: A detailed report of the residual solvent levels in the drug substance.

    2. Method validation: Documentation of instrument calibration, method validation, and quality control measures.

    3. Certification and accreditation: Evidence of laboratory accreditation and certification.

    Benefits include:

    1. Compliance with regulations: Ensures compliance with USP <467> and relevant national and international standards.

    2. Quality assurance: Validates the safety and efficacy of drug substances by detecting residual solvents.

    3. Risk assessment: Identifies potential risks to human health associated with residual solvent presence.

    Eurolabs laboratory testing service offers:

    1. Expertise: Highly trained and experienced personnel in USP <467> testing.

    2. State-of-the-art equipment: Modern instrumentation for accurate and reliable results.

    3. Accreditation and certification: Evidence of accreditation to international standards (ISO 17025:2017).

    4. Quality management systems: Implementation of quality control procedures to ensure data integrity.

    5. Competitive pricing: Offers a cost-effective testing service while maintaining technical accuracy.

    Conclusion

    USP <467> Residual Solvents Testing in Drug Substances is essential for ensuring product safety and efficacy. Eurolabs laboratory testing service provides accurate, reliable, and compliant results, ensuring compliance with regulatory requirements. By choosing Eurolab, companies can ensure their products meet the highest standards of quality and safety.

    References

    1. USP <467>: United States Pharmacopeia (2023). Residual Solvents in Pharmaceutical Products.

    2. ISO 17025:2017: International Organization for Standardization (2020). General Requirements for the Competence of Testing and Calibration Laboratories.

    3. ASTM E2609-19: American Society for Testing and Materials (2020). Test Method for Determination of Residual Solvents in Pharmaceutical Products.

    Note: This document is a comprehensive guide to USP <467> residual solvents testing in drug substances and Eurolabs laboratory testing service. It aims to provide detailed information on the standard, testing procedures, and benefits of choosing Eurolabs services.

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