EUROLAB
usp-85-bacterial-endotoxin-limits-related-to-impurity-safety
Impurity Profiling EMA Guideline on Genotoxic Impurities in PharmaceuticalsEMA Reflection Paper on Low Level ImpuritiesFDA Guidance: Microbial Impurities and Endotoxin LevelsFDA Guidance: Threshold of Toxicological Concern (TTC) for ImpuritiesFDA ICH M3(R2): Impurities in Safety StudiesFDA Q&A on Impurities in Generic Drug ApplicationsFDA Q&A: Managing Impurities in Complex APIsICH E14: QT Interval Evaluation and Impurity ImpactICH M7: Mutagenic Impurity Risk AssessmentICH Q10: Pharmaceutical Quality System for Impurity ManagementICH Q11: Impurity Control Strategy in Drug Substance DevelopmentICH Q12: Lifecycle Management of Impurity Control StrategyICH Q1E: Evaluation of Stability Data Related to Impurity FormationICH Q2(R1): Validation of Analytical Methods for Impurity TestingICH Q3A: Organic Impurity Profiling in Drug SubstancesICH Q3B: Impurity Testing in Finished Drug ProductsICH Q3C: Residual Solvent ProfilingICH Q3D: Elemental Impurity Risk AssessmentICH Q3F: Impurity Guidelines for Biotechnology ProductsICH Q4B: Harmonization of Analytical Procedures for Impurity TestingICH Q5C: Impurity Monitoring in Biotechnological ProductsICH Q6A: Specifications and Acceptance Criteria for ImpuritiesICH S3A: Impurities Arising from Degradation ProductsICH S6: Biotech Product Impurity ProfilingICH S7A: Safety Pharmacology Impurity EvaluationICH S9: Impurities in Oncology ProductsISO 10993-18: Chemical Characterization and Impurity AnalysisISO 17025: Accreditation for Impurity Testing LaboratoriesJP General Rule 2.60: Limit Test for ImpuritiesPh. Eur. 2.2.28: Gas Chromatography for Impurity DetectionPh. Eur. 2.2.38: Thin-Layer Chromatography for ImpuritiesPh. Eur. 2.2.46: Chromatographic Separation for Impurity AnalysisPh. Eur. 2.4.14: Determination of Inorganic ImpuritiesPh. Eur. 2.4.20: Limit Test for Heavy Metals in ImpuritiesPh. Eur. 2.4.24: Related Substances by HPLC in APIsPh. Eur. 2.4.29: Limit Test for Sulfated Ash ImpuritiesPh. Eur. 2.5.13: Oxidizing Impurity TestsPh. Eur. 2.9.40: Uniformity of Dosage Units and Related ImpuritiesPh. Eur. 5.10: Control of Impurities in Substances for Pharmaceutical UsePh. Eur. 5.4: Impurities in Radiopharmaceutical PreparationsUSP <1010>: Analytical Data Integrity in Impurity ReportingUSP <1031>: The Biocompatibility of Materials and ImpuritiesUSP <1051>: Cleaning Validation Limits and Residual ImpuritiesUSP <1058>: Analytical Instrument Qualification for Impurity StudiesUSP <1078>: Good Manufacturing Practices for Impurity ReductionUSP <1085>: Evaluation of Impurity Method PerformanceUSP <1086>: Impurities in Drug SubstancesUSP <1088>: Forced Degradation Studies for Impurity CharacterizationUSP <1091>: Impurity Isolation and Characterization TechniquesUSP <1099>: Acceptable Analytical Performance CriteriaUSP <1121>: Bulk Pharmaceutical Chemicals and Impurity HandlingUSP <1151>: Pharmaceutical Dosage Forms and Impurity ConsiderationUSP <1191>: Stability Testing of Compounded PreparationsUSP <1222>: Terminal Sterilization Impact on ImpuritiesUSP <1224>: Transfer of Impurity Test ProceduresUSP <1225>: Validation of Compendial Procedures for ImpuritiesUSP <1226>: Verification of Compendial Procedures for Impurity DetectionUSP <1231>: Water for Pharmaceutical Purposes and Impurity EffectsUSP <1232>: Water Activity and Impurity StabilityUSP <1241>: Capsules and Shell Impurity InteractionUSP <1251>: Weighing on Analytical Balances for Micro-ImpuritiesUSP <161>: Transdermal Delivery Systems and Impurity ControlUSP <197>: Spectrophotometric Identification of ImpuritiesUSP <233>: Elemental Impurities Profiling Using ICP-MSUSP <41>: Balances Used for Impurity Weight DeterminationUSP <466>: Identification and Quantification of DegradantsUSP <467>: Residual Solvent Testing in APIs and ExcipientsUSP <476>: Impurity Profiling for New Drug ApplicationsUSP <621>: Chromatography Conditions for Impurity IdentificationUSP <730>: Plasma Spectrochemistry for Impurity ProfilingUSP <791>: pH Determination Impact on Impurity SolubilityUSP <797>: Sterile Compounding and Impurity ControlUSP <800>: Hazardous Drug Handling Based on Impurity RiskUSP <851>: Spectrophotometry and Light Scattering for ImpuritiesUSP <853>: Atomic Absorption Spectroscopy for Trace ImpuritiesUSP <857>: UV-Vis Spectroscopy for Impurity QuantificationUSP <891>: Nuclear Magnetic Resonance (NMR) for Structural ElucidationUSP <905>: Content Uniformity Related to ImpuritiesUSP <905>: Uniformity of Dosage Units Affected by ImpuritiesUSP <941>: Characterization of Impurity Solubility and pKaWHO TRS 970 Annex 2: Impurity Control in Medicines

USP <85>: Bacterial Endotoxin Limits Related to Impurity Safety Testing: A Comprehensive Guide

Standard-Related Information

The United States Pharmacopeia (USP) is a non-profit organization that develops and publishes standards for the pharmaceutical industry. USP <85> is one of the many standards developed by USP to ensure the safety of pharmaceutical products.

What is USP <85>?

USP <85> is a standard that establishes limits related to impurity safety, specifically for bacterial endotoxins. Bacterial endotoxins are harmful substances produced by certain bacteria, such as Gram-negative bacteria. These toxins can cause adverse reactions in humans and animals.

Why is USP <85> important?

USP <85> is essential because it provides a framework for ensuring the safety of pharmaceutical products. Pharmaceutical manufacturers must comply with this standard to prevent the introduction of bacterial endotoxins into their products, which can lead to adverse reactions or even death.

Legal and Regulatory Framework

The USP <85> standard is based on various international and national standards, including:

  • ISO 7899-2:2000

  • ASTM E2187-09

  • EN 14675:2004

  • TSE 2161

    • These standards outline the testing methods for bacterial endotoxins in pharmaceutical products. Compliance with these standards is mandatory for all pharmaceutical manufacturers.

    International and National Standards

    USP <85> applies to various industries, including:

  • Pharmaceutical manufacturing

  • Biotechnology

  • Cosmetics

  • Medical devices

    • Compliance with this standard is essential to ensure the safety of end-users.

    Standard Development Organizations

    Several organizations contribute to the development and maintenance of standards related to USP <85>. These include:

  • International Organization for Standardization (ISO)

  • American Society for Testing and Materials (ASTM)

  • European Committee for Standardization (CEN)

    • These organizations work together to develop, maintain, and update standards related to bacterial endotoxins.

    Standard Evolution

    Standards evolve over time as new technologies and research become available. USP <85> has undergone revisions since its initial publication in 1997.

    Specific Standard Numbers and Scope

    Some of the key standard numbers related to USP <85> include:

  • ISO 7899-2:2000 - Water for injection

  • ASTM E2187-09 - Bacterial endotoxins test

  • EN 14675:2004 - Medical devices

    • These standards outline the testing methods and limits for bacterial endotoxins in various products.

    Standard Compliance Requirements

    Compliance with USP <85> requires:

  • Regular testing for bacterial endotoxins

  • Maintenance of accurate records

  • Calibration and validation of testing equipment

    • Failure to comply with these requirements can result in product recalls, legal action, or even loss of business licenses.

    Industrial Examples and Case Studies

    Here are some real-world examples of industries that require compliance with USP <85>:

    1. Pharmaceutical Manufacturing: Pharmaceutical companies must test their products for bacterial endotoxins to ensure they meet the required standards.

    2. Biotechnology: Biotech companies working on vaccines, sera, and other pharmaceutical products must also comply with USP <85>.

    3. Cosmetics: Cosmetic manufacturers may also require compliance with USP <85> for certain products.

    Standard-Related Information Conclusion

    USP <85> is a critical standard that ensures the safety of end-users by establishing limits related to impurity safety, specifically for bacterial endotoxins. Compliance with this standard requires regular testing, accurate records, and calibration/validation of testing equipment.

    ---

    Standard Requirements and Needs

    Why is USP <85> Required?

    USP <85> is necessary because it:

  • Ensures the safety of end-users by detecting potential harm from bacterial endotoxins

  • Provides a framework for compliance with regulatory requirements

  • Helps prevent product recalls, legal action, or loss of business licenses

    • Business and Technical Reasons for Conducting USP <85> Testing

    Pharmaceutical manufacturers must conduct USP <85> testing to:

  • Meet regulatory requirements

  • Ensure product safety

  • Maintain customer trust and confidence

  • Avoid costly recalls and lawsuits

  • Remain competitive in the market

    • Consequences of Not Performing USP <85> Testing

    Not performing USP <85> testing can result in:

  • Adverse reactions or even death due to bacterial endotoxins

  • Product recalls, legal action, or loss of business licenses

  • Loss of customer trust and confidence

  • Increased costs for corrective actions

    • Industries and Sectors Requiring USP <85> Testing

    USP <85> testing is required in various industries, including:

  • Pharmaceutical manufacturing

  • Biotechnology

  • Cosmetics

  • Medical devices

    • ---

    Standard Requirements and Needs Conclusion

    USP <85> is essential for ensuring the safety of end-users by detecting potential harm from bacterial endotoxins. Compliance with this standard requires regular testing, accurate records, and calibration/validation of testing equipment.

    ---

    How to Perform USP <85> Testing

    Testing Methods and Equipment

    USP <85> testing involves:

  • Sampling of product

  • Extraction of sample

  • Detection of endotoxins using a limulus amebocyte lysate (LAL) test or equivalent method

    • Calibration and Validation

    Equipment used for USP <85> testing must be calibrated and validated to ensure accuracy.

    Training and Certifications

    Personnel performing USP <85> testing should receive training and certification in accordance with relevant standards, such as ISO 17025.

    ---

    How to Perform USP <85> Testing Conclusion

    USP <85> testing involves sampling of product, extraction of sample, detection of endotoxins using a LAL test or equivalent method, calibration/validation of equipment, and training/certifications for personnel.

    ---

    Case Studies and Examples

    Real-World Applications of USP <85> Testing

    Here are some real-world examples of industries that require compliance with USP <85>:

    1. Pharmaceutical Manufacturing: Pharmaceutical companies must test their products for bacterial endotoxins to ensure they meet the required standards.

    2. Biotechnology: Biotech companies working on vaccines, sera, and other pharmaceutical products must also comply with USP <85>.

    3. Cosmetics: Cosmetic manufacturers may also require compliance with USP <85> for certain products.

    Benefits of Compliance with USP <85>

    Compliance with USP <85> provides numerous benefits, including:

  • Ensuring the safety of end-users

  • Maintaining customer trust and confidence

  • Avoiding costly recalls and lawsuits

  • Remaining competitive in the market

    • ---

    Case Studies and Examples Conclusion

    USP <85> testing is essential for ensuring the safety of end-users by detecting potential harm from bacterial endotoxins. Compliance with this standard requires regular testing, accurate records, and calibration/validation of testing equipment.

    ---

    Certifications and Training

    Training and Certification Requirements

    Personnel performing USP <85> testing must receive training and certification in accordance with relevant standards, such as ISO 17025.

    ISO 17025 Accreditation

    Laboratories performing USP <85> testing should be accredited to ISO 17025 for ensuring the accuracy of test results.

    ---

    Certifications and Training Conclusion

    USP <85> testing requires personnel training and certification in accordance with relevant standards, such as ISO 17025. Laboratories must also maintain accreditation to ensure accurate test results.

    ---

    Cost-Benefit Analysis

    Benefits of Compliance with USP <85>

    Compliance with USP <85> provides numerous benefits, including:

  • Ensuring the safety of end-users

  • Maintaining customer trust and confidence

  • Avoiding costly recalls and lawsuits

  • Remaining competitive in the market

    • Costs Associated with Non-Compliance

    Non-compliance with USP <85> can result in significant costs, including:

  • Product recalls

  • Legal action

  • Loss of business licenses

  • Decreased sales due to loss of customer trust and confidence

    • ---

    Cost-Benefit Analysis Conclusion

    Compliance with USP <85> provides numerous benefits while avoiding significant costs associated with non-compliance.

    Regulatory Environment

    Overview of Regulatory Requirements

    The regulatory environment for USP <85> testing includes:

  • USP <85>

  • ISO 7899-2:2000

  • ASTM E2187-09

  • EN 14675:2004

    • International and National Standards

    USP <85> applies to various industries, including:

  • Pharmaceutical manufacturing

  • Biotechnology

  • Cosmetics

  • Medical devices

    • Regulatory Compliance Requirements

    Compliance with USP <85> requires regular testing for bacterial endotoxins, maintenance of accurate records, calibration/validation of equipment.

    ---

    Regulatory Environment Conclusion

    USP <85> is a critical standard that ensures the safety of end-users by detecting potential harm from bacterial endotoxins. Compliance with this standard requires regular testing, accurate records, and calibration/validation of testing equipment.

    ---

    Conclusion

    USP <85> testing is essential for ensuring the safety of end-users by detecting potential harm from bacterial endotoxins. Compliance with this standard requires regular testing, accurate records, and calibration/validation of testing equipment.

    The benefits of compliance with USP <85> include:

  • Ensuring the safety of end-users

  • Maintaining customer trust and confidence

  • Avoiding costly recalls and lawsuits

  • Remaining competitive in the market

    • Non-compliance with USP <85> can result in significant costs, including:

  • Product recalls

  • Legal action

  • Loss of business licenses

  • Decreased sales due to loss of customer trust and confidence.

    • ---

    References

    1. USP <85>

    2. ISO 7899-2:2000

    3. ASTM E2187-09

    4. EN 14675:2004

    These references provide additional information on USP <85> testing, calibration/validation of equipment, and training/certifications for personnel.

    ---

    Final Thoughts

    USP <85> is a critical standard that ensures the safety of end-users by detecting potential harm from bacterial endotoxins. Compliance with this standard requires regular testing, accurate records, and calibration/validation of testing equipment.

    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