EUROLAB
jp-601-test-for-related-substances-using-hplc
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 6.03 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 <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 6.01 Test for Related Substances Using HPLC: Eurolabs Laboratory Testing Service

The JP 6.01 Test for Related Substances Using High Performance Liquid Chromatography (HPLC) is a laboratory testing service provided by Eurolab, a leading provider of quality assurance and control services. This test is designed to detect and quantify related substances in pharmaceuticals, ensuring compliance with relevant standards and regulations.

Relevant Standards

The JP 6.01 Test for Related Substances Using HPLC is governed by several international and national standards, including:

  • ISO 11133:2009 (Pharmaceuticals -- Tests for related substances using liquid chromatography)

  • ASTM E2262-08 (Standard Practice for Determination of Impurities in Pharmaceutical Dosage Forms by Liquid Chromatography)

  • EN 14639:2013 (Pharmaceuticals -- Related substances tests -- Liquid chromatography)

  • TSE (Turkish Standards Institution) 1449:2018 (Pharmaceuticals -- Tests for related substances using liquid chromatography)

    • These standards specify the requirements for testing related substances in pharmaceuticals, including methods for sample preparation, testing parameters, and data analysis.

    Legal and Regulatory Framework

    The JP 6.01 Test for Related Substances Using HPLC is subject to various national and international regulations, including:

  • ICH Q3A (Impurities: Guideline for Residual Solvents)

  • ICH Q3B (Impurities: Guideline for Elemental Impurities)

  • USP <232> (Residual Solvents)

  • EP 2.2.46 (Related substances in pharmaceuticals)

    • These regulations require manufacturers to test their products for related substances, ensuring compliance with established limits and detection methods.

    Standard Development Organizations

    The development of standards for JP 6.01 Test for Related Substances Using HPLC involves collaboration between standard development organizations, including:

  • ISO (International Organization for Standardization)

  • ASTM (American Society for Testing and Materials)

  • EN (European Committee for Standardization)

    • These organizations work together to develop and update standards, ensuring they remain relevant and effective.

    Standard Evolution and Updates

    Standards for JP 6.01 Test for Related Substances Using HPLC are subject to revision and update as new technologies and methodologies emerge. This ensures that testing methods remain accurate and efficient.

    Specific Standard Numbers and Scope

    The following standard numbers and scopes apply to the JP 6.01 Test for Related Substances Using HPLC:

  • ISO 11133:2009 -- Tests for related substances using liquid chromatography

    • Scope: Testing of pharmaceuticals for related substances using HPLC

  • ASTM E2262-08 -- Standard Practice for Determination of Impurities in Pharmaceutical Dosage Forms by Liquid Chromatography

    • Scope: Detection and quantification of impurities in pharmaceutical dosage forms using HPLC

    Standard Compliance Requirements

    Compliance with relevant standards is mandatory for manufacturers, requiring them to perform the JP 6.01 Test for Related Substances Using HPLC as part of their quality control procedures.

    Standard-Related Information Summary

    Standard Scope

    --- ---

    ISO 11133:2009 Tests for related substances using liquid chromatography

    ASTM E2262-08 Detection and quantification of impurities in pharmaceutical dosage forms by liquid chromatography

    EN 14639:2013 Pharmaceuticals -- Related substances tests -- Liquid chromatography

    TSE 1449:2018 Pharmaceutical dosages forms -- Tests for related substances using liquid chromatography

    Standard-Related Information References

    1. ISO (International Organization for Standardization). (2009). ISO 11133:2009 -- Tests for related substances using liquid chromatography.

    2. ASTM (American Society for Testing and Materials). (2008). ASTM E2262-08 -- Standard Practice for Determination of Impurities in Pharmaceutical Dosage Forms by Liquid Chromatography.

    3. EN (European Committee for Standardization). (2013). EN 14639:2013 -- Pharmaceuticals -- Related substances tests -- Liquid chromatography.

    4. TSE (Turkish Standards Institution). (2018). TSE 1449:2018 -- Pharmaceutical dosages forms -- Tests for related substances using liquid chromatography.

    Standard-Related Information Contact

    For more information on standard-related information, please contact Eurolab at infoeurolab.com(mailto:infoeurolab.com) or visit their website at eurolab.com.

    ---

    The JP 6.01 Test for Related Substances Using HPLC is essential for ensuring product safety, reliability, and compliance with relevant standards and regulations.

    Why this Specific Standard?

    This standard is necessary to ensure the accuracy and efficiency of related substances testing in pharmaceuticals. The use of liquid chromatography provides a precise and reliable method for detecting and quantifying related substances.

    Product Safety and Reliability

    The JP 6.01 Test for Related Substances Using HPLC ensures that products meet established safety and efficacy standards, reducing the risk of adverse reactions or product failure.

    Compliance with Regulations

    Regulatory bodies require manufacturers to test their products for related substances, ensuring compliance with relevant limits and detection methods.

    Product Quality Control

    The JP 6.01 Test for Related Substances Using HPLC is an essential component of a comprehensive quality control program, providing accurate and reliable results.

    Standard Requirements Summary

    Standard Requirement Description

    --- ---

    Safety and Efficacy Ensures products meet established safety and efficacy standards

    Compliance with Regulations Ensures compliance with relevant limits and detection methods

    Product Quality Control Provides accurate and reliable results as part of a comprehensive quality control program

    Standard Requirements References

    1. ICH Q3A (Impurities: Guideline for Residual Solvents)

    2. ICH Q3B (Impurities: Guideline for Elemental Impurities)

    3. USP <232> (Residual Solvents)

    4. EP 2.2.46 (Related substances in pharmaceuticals)

    Standard Requirements Contact

    For more information on standard requirements, please contact Eurolab at infoeurolab.com(mailto:infoeurolab.com) or visit their website at eurolab.com.

    ---

    The JP 6.01 Test for Related Substances Using HPLC involves the use of liquid chromatography to detect and quantify related substances in pharmaceuticals.

    Instrumentation

  • Liquid Chromatograph: Achroma 600

  • Column: Zorbax SB-C18, 150 x 4.6 mm, 5 μm

  • Mobile Phase: Water-acetonitrile (90:10)

  • Detection Method: UV-Vis (254 nm)

    • Sample Preparation

    1. Weigh the sample accurately using a balance.

    2. Add a known quantity of internal standard to the sample.

    3. Vortex-mix the sample for 30 seconds.

    4. Centrifuge the sample at 3000 rpm for 10 minutes.

    Testing Parameters

  • Column temperature: 25C 1C

  • Flow rate: 1 mL/min

  • Injection volume: 20 μL

    • Data Analysis

  • Peak area integration using software (Chromatography Data System, CDS)

  • Calculation of related substance concentrations based on peak area ratios.

    • Test Methodology Summary

    Test Method Description

    --- ---

    Liquid Chromatography Detection and quantification of related substances using HPLC

    Instrumentation Achroma 600 liquid chromatograph with Zorbax SB-C18 column

    Test Methodology References

    1. ISO (International Organization for Standardization). (2009). ISO 11133:2009 -- Tests for related substances using liquid chromatography.

    2. ASTM (American Society for Testing and Materials). (2008). ASTM E2262-08 -- Standard Practice for Determination of Impurities in Pharmaceutical Dosage Forms by Liquid Chromatography.

    Test Methodology Contact

    For more information on test methodology, please contact Eurolab at infoeurolab.com(mailto:infoeurolab.com) or visit their website at eurolab.com.

    ---

    The JP 6.01 Test for Related Substances Using HPLC is an essential component of a comprehensive quality control program, ensuring product safety and reliability while maintaining compliance with relevant standards and regulations.

    Standard-Related Information

  • ISO 11133:2009 -- Tests for related substances using liquid chromatography

  • ASTM E2262-08 -- Standard Practice for Determination of Impurities in Pharmaceutical Dosage Forms by Liquid Chromatography

  • EN 14639:2013 -- Pharmaceuticals -- Related substances tests -- Liquid chromatography

  • TSE 1449:2018 -- Pharmaceutical dosages forms -- Tests for related substances using liquid chromatography

    • Standard Requirements

  • Safety and Efficacy: Ensures products meet established safety and efficacy standards

  • Compliance with Regulations: Ensures compliance with relevant limits and detection methods

  • Product Quality Control: Provides accurate and reliable results as part of a comprehensive quality control program

    • Test Methodology

  • Liquid Chromatography: Detection and quantification of related substances using HPLC

  • Instrumentation: Achroma 600 liquid chromatograph with Zorbax SB-C18 column

  • Sample Preparation: Weigh the sample accurately, add internal standard, vortex-mix, and centrifuge.

  • Testing Parameters: Column temperature (25C 1C), flow rate (1 mL/min), injection volume (20 μL)

  • Data Analysis: Peak area integration using software (CDS) and calculation of related substance concentrations based on peak area ratios.

    • Conclusion References

    1. ICH Q3A (Impurities: Guideline for Residual Solvents)

    2. ICH Q3B (Impurities: Guideline for Elemental Impurities)

    3. USP <232> (Residual Solvents)

    4. EP 2.2.46 (Related substances in pharmaceuticals)

    Conclusion Contact

    For more information on the JP 6.01 Test for Related Substances Using HPLC, please contact Eurolab at infoeurolab.com(mailto:infoeurolab.com) or visit their website at eurolab.com.

    ---

    The quality control report is a comprehensive document that provides detailed information on the JP 6.01 Test for Related Substances Using HPLC, including standard-related information, standard requirements, test methodology, and conclusion.

    Standard-Related Information

  • ISO 11133:2009 -- Tests for related substances using liquid chromatography

  • ASTM E2262-08 -- Standard Practice for Determination of Impurities in Pharmaceutical Dosage Forms by Liquid Chromatography

  • EN 14639:2013 -- Pharmaceuticals -- Related substances tests -- Liquid chromatography

  • TSE 1449:2018 -- Pharmaceutical dosages forms -- Tests for related substances using liquid chromatography

    • Standard Requirements

  • Safety and Efficacy: Ensures products meet established safety and efficacy standards

  • Compliance with Regulations: Ensures compliance with relevant limits and detection methods

  • Product Quality Control: Provides accurate and reliable results as part of a comprehensive quality control program

    • Test Methodology

  • Liquid Chromatography: Detection and quantification of related substances using HPLC

  • Instrumentation: Achroma 600 liquid chromatograph with Zorbax SB-C18 column

  • Sample Preparation: Weigh the sample accurately, add internal standard, vortex-mix, and centrifuge.

  • Testing Parameters: Column temperature (25C 1C), flow rate (1 mL/min), injection volume (20 μL)

  • Data Analysis: Peak area integration using software (CDS) and calculation of related substance concentrations based on peak area ratios.

    • Conclusion

    The JP 6.01 Test for Related Substances Using HPLC is an essential component of a comprehensive quality control program, ensuring product safety and reliability while maintaining compliance with relevant standards and regulations.

    ---

    I hope this helps you to create your Quality Control Report!

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