EUROLAB
jp-901-chromatographic-purity-for-active-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 9.04 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 9.01 Chromatographic Purity for Active Substances Laboratory Testing Service: A Comprehensive Guide

The JP 9.01 Chromatographic Purity for Active Substances testing service is governed by a range of international and national standards that ensure the accuracy, reliability, and quality of laboratory results. The following standards are relevant to this specific test:

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

  • ISO 9001:2015: Quality management systems - Requirements

  • EN ISO 11133:2009: Microbiology of food, water, animal feeding stuffs, and veterinary products - Preparation of test samples, initial suspension and decimal dilution series

  • ASTM E1610-12: Standard Practice for Conducting an Interlaboratory Study to Evaluate the Measurement Methodology

  • TSE 2222:2017: Pharmaceutical raw materials and preparations - General rules

    • These standards are developed by organizations such as the International Organization for Standardization (ISO), American Society for Testing and Materials (ASTM), and Turkish Standards Institution (TSE). The development of these standards is a continuous process, with regular reviews and updates to ensure that they remain relevant and effective.

    The legal and regulatory framework surrounding this testing service includes:

  • Good Laboratory Practice (GLP): A set of principles aimed at ensuring the quality and integrity of laboratory results

  • Good Manufacturing Practice (GMP): Guidelines for the manufacture of pharmaceutical products, including the control of raw materials and active substances

  • Regulatory requirements: Specific regulations governing the testing and approval of active substances in various jurisdictions

    • In addition to these standards and regulations, Eurolab is committed to maintaining a quality management system that meets the requirements of ISO 9001:2015. This ensures that our laboratory results are accurate, reliable, and compliant with all relevant regulatory requirements.

    The JP 9.01 Chromatographic Purity for Active Substances testing service is required to ensure the quality and purity of active substances used in pharmaceutical products. The business and technical reasons for conducting this test include:

  • Ensuring product safety: The presence of impurities or contaminants can pose a risk to public health

  • Meeting regulatory requirements: Compliance with relevant standards and regulations is essential for the approval and marketing of pharmaceutical products

  • Maintaining quality control: Regular testing helps to ensure that active substances meet specified purity levels and are free from contaminants

  • Avoiding product recalls: Testing can help to prevent product recalls due to contamination or impurities

    • The industries and sectors that require this testing service include:

  • Pharmaceutical manufacturing: The production of pharmaceutical products, including tablets, capsules, and injections

  • Cosmetics and personal care: The development and manufacture of cosmetic and personal care products, such as skincare creams and haircare shampoos

  • Food and beverage: The production and packaging of food and beverage products, including nutritional supplements

    • The risk factors and safety implications associated with this testing service include:

  • Contamination: The presence of impurities or contaminants can pose a risk to public health

  • Product failure: Failure to meet regulatory requirements can result in product recalls or market withdrawal

  • Financial losses: Non-compliance with regulations can lead to financial penalties, fines, and reputational damage

    • Eurolabs JP 9.01 Chromatographic Purity for Active Substances testing service is designed to mitigate these risks by ensuring that active substances meet specified purity levels and are free from contaminants.

    The JP 9.01 Chromatographic Purity for Active Substances testing service involves the following steps:

    1. Sample preparation: The active substance is prepared according to specific guidelines, including extraction, dissolution, or other procedures as required

    2. Instrument calibration: The chromatography equipment is calibrated and validated to ensure accurate results

    3. Testing parameters: The testing parameters are set according to the relevant standard, including temperature, flow rate, and detection wavelength

    4. Chromatographic separation: The active substance is separated from impurities using a suitable chromatographic technique, such as liquid chromatography (LC) or gas chromatography (GC)

    5. Detection and quantification: The presence of impurities is detected and quantified using suitable detectors, such as ultraviolet (UV), mass spectrometry (MS), or tandem MS

    6. Data analysis: The test results are analyzed and reported according to the relevant standard

    The testing equipment and instruments used include:

  • Liquid chromatography (LC) systems: Equipped with UV, MS, or tandem MS detectors

  • Gas chromatography (GC) systems: Equipped with flame ionization (FID) or electron capture (ECD) detectors

  • Mass spectrometry (MS): Equipped with a quadrupole or time-of-flight detector

    • The testing parameters are set according to the relevant standard, including:

  • Temperature: 20C 2C

  • Flow rate: 1.0 mL/min 0.5 mL/min

  • Detection wavelength: 254 nm 10 nm

    • Eurolabs experienced technicians and analysts ensure that all testing is carried out according to the relevant standard, using suitable equipment and instruments.

    Conclusion

    The JP 9.01 Chromatographic Purity for Active Substances laboratory testing service is a critical component of the pharmaceutical industry, ensuring the quality and purity of active substances used in pharmaceutical products. By complying with relevant standards and regulations, Eurolab provides accurate and reliable results that support product safety and regulatory compliance.

    Appendix

    The following tables provide a summary of the standard-related information:

    Standard Title

    --- ---

    ISO/IEC 17025:2017 General requirements for the competence of testing and calibration laboratories

    ISO 9001:2015 Quality management systems - Requirements

    EN ISO 11133:2009 Microbiology of food, water, animal feeding stuffs, and veterinary products - Preparation of test samples, initial suspension and decimal dilution series

    ASTM E1610-12 Standard Practice for Conducting an Interlaboratory Study to Evaluate the Measurement Methodology

    TSE 2222:2017 Pharmaceutical raw materials and preparations - General rules

    The following tables provide a summary of the standard requirements and needs:

    Industry/ Sector Risk Factors/Safety Implications

    --- ---

    Pharmaceutical manufacturing Contamination, product failure, financial losses

    Cosmetics and personal care Contamination, product failure, reputational damage

    Food and beverage Contamination, product failure, financial losses

    The following tables provide a summary of the test conditions and methodology:

    Step Description

    --- ---

    1. Sample preparation Preparation of active substance according to specific guidelines

    2. Instrument calibration Calibration and validation of chromatography equipment

    3. Testing parameters Setting of testing parameters according to relevant standard

    4. Chromatographic separation Separation of active substance from impurities using suitable chromatographic technique

    5. Detection and quantification Detection and quantification of impurities using suitable detectors

    6. Data analysis Analysis and reporting of test results according to relevant standard

    The following tables provide a summary of the testing equipment and instruments used:

    Equipment/Instrument Description

    --- ---

    Liquid chromatography (LC) systems Equipped with UV, MS, or tandem MS detectors

    Gas chromatography (GC) systems Equipped with flame ionization (FID) or electron capture (ECD) detectors

    Mass spectrometry (MS) Equipped with quadrupole or time-of-flight detector

    The following tables provide a summary of the testing parameters:

    Parameter Description

    --- ---

    Temperature 20C 2C

    Flow rate 1.0 mL/min 0.5 mL/min

    Detection wavelength 254 nm 10 nm

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