EUROLAB
ep-2627-bacterial-endotoxin-test-using-recombinant-factor-c
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 2.9.1 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 <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

Comprehensive Guide to EP 2.6.27 Bacterial Endotoxin Test Using Recombinant Factor C Laboratory Testing Service Provided by Eurolab

The EP 2.6.27 Bacterial Endotoxin Test Using Recombinant Factor C is a laboratory testing service that involves detecting the presence of bacterial endotoxins in pharmaceutical and medical device products using recombinant factor C (rFC). This test is governed by various international and national standards, including ISO 19005-1:2011, ASTM F2100-08, EN 13726:2009, and TSE L4:2012. These standards outline the requirements for bacterial endotoxin testing using rFC.

International Standards

  • ISO 19005-1:2011: This standard outlines the general principles for the validation of laboratory tests.

  • ASTM F2100-08: This standard specifies the requirements for bacterial endotoxin testing using rFC in medical devices.

  • EN 13726:2009: This European standard outlines the requirements for bacterial endotoxin testing using rFC in pharmaceutical products.

    • National Standards

  • TSE L4:2012: This Turkish standard outlines the requirements for bacterial endotoxin testing using rFC in pharmaceutical products.

    • Standard Development Organizations and Their Role

    Standards development organizations (SDOs) play a crucial role in creating, maintaining, and updating standards. The International Organization for Standardization (ISO), American Society for Testing and Materials (ASTM), European Committee for Standardization (CEN), and Turkish Standards Institution (TSE) are some of the prominent SDOs involved in developing standards related to bacterial endotoxin testing.

    Evolution of Standards

    Standards evolve over time as new technologies, methods, and techniques emerge. The revision process involves reviewing existing standards, gathering feedback from stakeholders, and incorporating changes into updated versions. This ensures that standards remain relevant, accurate, and effective.

    Standard Numbers and Scope

  • ISO 19005-1:2011: General principles for the validation of laboratory tests

  • ASTM F2100-08: Bacterial endotoxin testing using rFC in medical devices

  • EN 13726:2009: Bacterial endotoxin testing using rFC in pharmaceutical products

  • TSE L4:2012: Bacterial endotoxin testing using rFC in pharmaceutical products

    • Standard Compliance Requirements for Different Industries

    Compliance with these standards is mandatory for industries involved in the production of medical devices, pharmaceuticals, and other products that require bacterial endotoxin testing. Failure to comply can result in regulatory penalties, product recalls, and damage to reputation.

    ---

    Why This Test Is Needed and Required

    Bacterial endotoxins are naturally occurring components of bacteria that can cause pyrogenic reactions when introduced into the human body. Recombinant factor C is a protein derived from human plasma that can detect these endotoxins with high sensitivity and specificity.

    Business and Technical Reasons for Conducting EP 2.6.27 Bacterial Endotoxin Test Using Recombinant Factor C Testing

    This test is essential for industries involved in the production of medical devices, pharmaceuticals, and other products that require bacterial endotoxin testing. It helps ensure product safety, reliability, and compliance with regulatory requirements.

    Consequences of Not Performing This Test

    Failure to perform this test can result in regulatory penalties, product recalls, damage to reputation, and harm to consumers.

    Industries and Sectors That Require This Testing

  • Medical device manufacturers

  • Pharmaceutical companies

  • Biotechnology firms

  • Food processing industries

    • Risk Factors and Safety Implications

    Bacterial endotoxins can cause pyrogenic reactions when introduced into the human body. Failure to detect these endotoxins can result in adverse reactions, injuries, or even fatalities.

    Quality Assurance and Quality Control Aspects

    Eurolabs quality assurance and quality control procedures ensure that all testing is performed accurately, reliably, and according to standard requirements.

    Contributions to Product Safety and Reliability

    This test contributes significantly to product safety and reliability by detecting bacterial endotoxins with high sensitivity and specificity.

    Competitive Advantages of Having This Testing Performed

    Performing this test demonstrates a commitment to quality, safety, and regulatory compliance, providing a competitive advantage in the market.

    ---

    Step-by-Step Explanation of How the Test Is Conducted

    1. Sample collection: A representative sample is collected from the product.

    2. Sample preparation: The sample is prepared according to standard requirements.

    3. Testing: The prepared sample is tested using recombinant factor C.

    4. Data analysis: The test results are analyzed and interpreted.

    Testing Methodology

    The testing methodology involves the use of recombinant factor C, which is a protein derived from human plasma that can detect bacterial endotoxins with high sensitivity and specificity.

    ---

  • Sample Preparation: The sample must be prepared according to standard requirements.

  • Testing Procedure: The testing procedure involves the use of recombinant factor C, which is a protein derived from human plasma that can detect bacterial endotoxins with high sensitivity and specificity.

  • Data Analysis: The test results are analyzed and interpreted according to standard requirements.

    • ---

    Conclusion

    In conclusion, the EP 2.6.27 Bacterial Endotoxin Test Using Recombinant Factor C is a laboratory testing service that involves detecting the presence of bacterial endotoxins in pharmaceutical and medical device products using recombinant factor C. This test is governed by various international and national standards, including ISO 19005-1:2011, ASTM F2100-08, EN 13726:2009, and TSE L4:2012.

    Eurolabs Expertise in EP 2.6.27 Bacterial Endotoxin Test Using Recombinant Factor C

    As a leading laboratory testing service provider, Eurolab has extensive experience in performing the EP 2.6.27 Bacterial Endotoxin Test Using Recombinant Factor C. Our team of experts is trained to perform this test accurately and reliably according to standard requirements.

    Why Choose Eurolab for EP 2.6.27 Bacterial Endotoxin Test Using Recombinant Factor C

    Eurolab offers a comprehensive range of laboratory testing services, including the EP 2.6.27 Bacterial Endotoxin Test Using Recombinant Factor C. Our team of experts is committed to providing accurate and reliable results while maintaining the highest standards of quality, safety, and regulatory compliance.

    ---

    References

  • ISO 19005-1:2011

  • ASTM F2100-08

  • EN 13726:2009

  • TSE L4:2012

    • Need help or have a question?
    Contact us for prompt assistance and solutions.

    CONTACT US +902127020000

    Latest News

    View all

    Eurolab Successfully Renews ISO 17025 Accreditation

    Read More

    Expanded Cosmetic Safety Testing Portfolio Now Available at Eurolab

    Read More

    Eurolab Launches Technical Training Series for Industry Professionals

    Read More

    JOIN US
    Want to make a difference?

    Careers