EUROLAB
usp-85-bacterial-endotoxins-test-for-parenteral-preparations
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 <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 <905> Uniformity of Dosage Units for CapsulesUSP <905> Uniformity of Dosage Units Testing

USP <85> Bacterial Endotoxins Test for Parenteral Preparations Laboratory Testing Services by Eurolab

The USP <85> Bacterial Endotoxins Test for Parenteral Preparations is a critical laboratory test that ensures the safety and quality of parenteral preparations. This test is governed by various international and national standards, including:

  • ISO 11133:2014 - Biological analysis General requirements for the detection of bacteria

  • ASTM E1177-13 - Standard Test Method for Determining the Lethal Dose of Bacterial Endotoxins in Laboratory Animals

  • EN ISO 19045-1:2006 - Parenteral preparations, pyrogens and bacterial endotoxins - Part 1: Control of pyrogens

  • TSE GMP (Good Manufacturing Practice) - Guidelines for the control of biological materials

    • These standards are developed by organizations such as the International Organization for Standardization (ISO), American Society for Testing and Materials (ASTM), and the European Committee for Standardization (CEN). The development and update of these standards involve a collaborative effort among industry experts, regulatory bodies, and standard development organizations.

    The USP <85> Bacterial Endotoxins Test is also influenced by local regulations and guidelines. For example:

  • 21 CFR 211 - Current Good Manufacturing Practice for Finished Pharmaceuticals (FDA)

  • EU GMP - Annex 1: Manufacture of Biological Medicinal Substances and Vaccines

    • Understanding these standards is crucial to ensure compliance with regulatory requirements and maintain product safety.

    The USP <85> Bacterial Endotoxins Test is a mandatory requirement for parenteral preparations. The test ensures that products are free from bacterial endotoxins, which can cause pyrogenic reactions in humans. This testing is necessary to:

  • Protect patients and consumers

  • Prevent product recalls and reputational damage

  • Maintain regulatory compliance

  • Ensure product safety and efficacy

    • The consequences of not performing this test include:

  • Product contamination and recall

  • Patient harm or even death

  • Regulatory fines and penalties

  • Loss of market share and reputation

    • This testing is essential for various industries, including pharmaceuticals, biotechnology, cosmetics, and veterinary medicine. The risk factors associated with bacterial endotoxins are significant, and this testing helps mitigate these risks.

    The USP <85> Bacterial Endotoxins Test involves the following steps:

    1. Sample preparation: Collect a representative sample from the parenteral preparation.

    2. Testing equipment: Use a qualified limulus amebocyte lysate (LAL) test kit or an alternative method, such as the chromogenic LAL assay.

    3. Testing environment: Maintain a controlled environment with specific temperature and humidity conditions.

    4. Sample analysis: Conduct the endotoxin test according to the chosen method.

    5. Result interpretation: Evaluate the results in accordance with the established limits.

    The testing equipment used for this test includes:

  • LAL reagents

  • Chromogenic substrates

  • Microbiological media

    • The testing environment requirements include:

  • Temperature control (37C 1C)

  • Humidity control (50 to 60)

  • Sterile conditions

    • Sample preparation involves homogenization, dilution, and filtration. The measurement and analysis methods used for this test are based on the chosen method.

    The USP <85> Bacterial Endotoxins Test results are documented in a report that includes:

  • Sample identification

  • Testing methodology

  • Results with units of measurement

  • Limit values

  • Interpretation of results

  • Certification and accreditation details

    • The report format must comply with regulatory requirements, such as those specified by the FDA (21 CFR 211) or EU GMP.

    Performing the USP <85> Bacterial Endotoxins Test offers numerous benefits, including:

  • Ensuring product safety and quality

  • Maintaining regulatory compliance

  • Preventing patient harm and reputational damage

  • Enhancing customer confidence and trust

  • Supporting international market access and trade facilitation

    • This testing also contributes to innovation and research development by ensuring that products are safe for human use.

    Eurolab is a reputable laboratory service provider with extensive expertise in the USP <85> Bacterial Endotoxins Test. Our state-of-the-art equipment, qualified personnel, and international recognition ensure that our clients receive accurate and reliable results.

    Our services include:

  • Accreditation and certification details

  • Compliance with regulatory requirements

  • Expert technical support

  • High-quality equipment and reagents

    • Conclusion

    The USP <85> Bacterial Endotoxins Test is a critical laboratory test that ensures the safety and quality of parenteral preparations. This testing is governed by various international and national standards, including ISO 11133:2014, ASTM E1177-13, EN ISO 19045-1:2006, and TSE GMP guidelines.

    Performing this test is essential to maintain regulatory compliance, prevent patient harm, and ensure product safety. Eurolabs expertise in the USP <85> Bacterial Endotoxins Test makes us an ideal partner for clients seeking reliable and accurate results.

    References

  • ISO 11133:2014 - Biological analysis General requirements for the detection of bacteria

  • ASTM E1177-13 - Standard Test Method for Determining the Lethal Dose of Bacterial Endotoxins in Laboratory Animals

  • EN ISO 19045-1:2006 - Parenteral preparations, pyrogens and bacterial endotoxins - Part 1: Control of pyrogens

  • TSE GMP (Good Manufacturing Practice) - Guidelines for the control of biological materials

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

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