EUROLAB
jp-604-analysis-of-pesticide-residues-in-herbal-medicines
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 6.05 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 <467> Residual Solvents Testing in Drug SubstancesUSP <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

JP 6.04 Analysis of Pesticide Residues in Herbal Medicines Laboratory Testing Service: A Comprehensive Guide

The JP 6.04 Analysis of Pesticide Residues in Herbal Medicines laboratory testing service is governed by various international and national standards. These standards ensure the accuracy, precision, and reliability of the testing results.

International Standards:

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

  • ISO/IEC 17020: Conformity assessment Requirements for the inspection body

  • ISO 9001: Quality management systems Requirements

    • National Standards:

  • EU Directive 2009/128/EC on sustainable use of pesticides

  • EU Regulation 1226/2004 on pesticide residues in foodstuffs

  • US EPAs Pesticide Residue Monitoring Program (PRMP)

  • Canadian Pest Management Regulatory Agency (PMRA) guidelines

    • Standard Development Organizations:

  • International Organization for Standardization (ISO)

  • American Society for Testing and Materials (ASTM)

  • European Committee for Standardization (CEN)

  • Turkish Standards Institution (TSE)

    • How Standards Evolve and Get Updated:

    Standards are developed, reviewed, and updated by standard development organizations. The process involves:

    1. Identification of needs and requirements

    2. Development of new standards or revisions to existing ones

    3. Review and approval by the relevant technical committee

    4. Publication and implementation

    Specific Standard Numbers and Their Scope:

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

    • Scope: Provides general requirements for the competence of testing and calibration laboratories

  • EU Directive 2009/128/EC on sustainable use of pesticides

    • Scope: Regulates the use of pesticides in a way that minimizes their impact on human health, the environment, and wildlife

    Standard Compliance Requirements for Different Industries:

  • Pharmaceuticals: Comply with Good Manufacturing Practice (GMP) regulations

  • Food industry: Comply with EU Regulation 1226/2004 on pesticide residues in foodstuffs

  • Cosmetics industry: Comply with EU Cosmetic Directive 76/768/EEC

    • Standard-Related Information Conclusion:

    The JP 6.04 Analysis of Pesticide Residues in Herbal Medicines laboratory testing service is governed by various international and national standards. These standards ensure the accuracy, precision, and reliability of the testing results.

    ---

    The JP 6.04 Analysis of Pesticide Residues in Herbal Medicines testing service is essential for ensuring product safety and quality. The requirements and needs for this test are as follows:

    Why This Specific Test Is Needed and Required:

  • Ensures the safety of herbal medicines by detecting pesticide residues

  • Complies with regulatory requirements (e.g., EU Directive 2009/128/EC)

  • Protects human health and the environment

    • Business and Technical Reasons for Conducting JP 6.04 Analysis of Pesticide Residues in Herbal Medicines Testing:

  • Ensures product quality and safety

  • Complies with regulatory requirements (e.g., EU Directive 2009/128/EC)

  • Protects brand reputation and customer trust

    • Consequences of Not Performing This Test:

  • Non-compliance with regulatory requirements (e.g., EU Directive 2009/128/EC)

  • Risk to human health and the environment

  • Damage to brand reputation and customer trust

    • Industries and Sectors That Require This Testing:

  • Herbal medicine manufacturers

  • Pharmaceutical companies

  • Cosmetics industry

  • Food industry

    • Risk Factors and Safety Implications:

  • Exposure to pesticide residues can lead to adverse health effects (e.g., cancer, neurological damage)

  • Pesticide residues in herbal medicines can contaminate the environment

    • Quality Assurance and Quality Control Aspects:

  • Ensures accurate and precise testing results

  • Complies with regulatory requirements (e.g., EU Directive 2009/128/EC)

    • How This Test Contributes to Product Safety and Reliability:

  • Ensures product quality and safety

  • Protects human health and the environment

    • Competitive Advantages of Having This Testing Performed:

  • Enhanced brand reputation and customer trust

  • Compliance with regulatory requirements (e.g., EU Directive 2009/128/EC)

  • Competitive advantage in the market

    • Cost-Benefit Analysis of Performing This Test:

  • Costs associated with testing (e.g., equipment, personnel)

  • Benefits associated with compliance (e.g., enhanced brand reputation, reduced risk)

    • ---

    The JP 6.04 Analysis of Pesticide Residues in Herbal Medicines laboratory testing service involves the following test conditions and methodology:

    Test Conditions:

  • Sample preparation

  • Instrumentation (e.g., gas chromatography-mass spectrometry)

  • Analytical methods (e.g., liquid-liquid extraction, solid-phase microextraction)

    • Methodology:

    1. Sample preparation:

    Extraction of pesticide residues from the herbal medicine sample

    Cleanup and concentration of the extract

    2. Instrumentation:

    Gas chromatography-mass spectrometry (GC-MS) for detection and quantification of pesticide residues

    3. Analytical methods:

    Liquid-liquid extraction (LLE) for extraction of pesticide residues

    Solid-phase microextraction (SPME) for extraction of pesticide residues

    Instrumentation and Equipment:

  • Gas chromatography-mass spectrometry (GC-MS)

  • Liquid chromatography-tandem mass spectrometry (LC-MS/MS)

  • Solid-phase microextraction (SPME)

    • Analytical Methods:

  • Liquid-liquid extraction (LLE) for extraction of pesticide residues

  • Solid-phase microextraction (SPME) for extraction of pesticide residues

    • ---

    Test Conditions and Methodology Conclusion:

    The JP 6.04 Analysis of Pesticide Residues in Herbal Medicines laboratory testing service involves the following test conditions and methodology:

  • Sample preparation

  • Instrumentation (e.g., gas chromatography-mass spectrometry)

  • Analytical methods (e.g., liquid-liquid extraction, solid-phase microextraction)

    • ---

    Standard Requirements and Needs Conclusion:

    The JP 6.04 Analysis of Pesticide Residues in Herbal Medicines testing service is essential for ensuring product safety and quality. The requirements and needs for this test are as follows:

  • Ensures the safety of herbal medicines by detecting pesticide residues

  • Complies with regulatory requirements (e.g., EU Directive 2009/128/EC)

  • Protects human health and the environment

    • ---

    Conclusion:

    The JP 6.04 Analysis of Pesticide Residues in Herbal Medicines laboratory testing service is a critical component of ensuring product safety and quality. This comprehensive guide has provided an overview of the standard-related information, standard requirements and needs, and test conditions and methodology for this testing service.

    ---

    Appendix:

  • List of relevant standards and regulations

  • Glossary of terms related to pesticide residues in herbal medicines

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