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Pharmacopoeia-Based Assays/
USP <467> Residual Solvents Testing in Drug SubstancesUSP <467> Residual Solvents Testing in Drug Substances: Eurolabs Laboratory Testing Service
The testing of residual solvents in drug substances is governed by the United States Pharmacopeia (USP) <467> standard, which provides a framework for the identification and quantitation of residual solvents in pharmaceutical products. The USP <467> standard is based on international standards such as ISO 17025:2017 and ASTM E2609-19.
The regulatory framework surrounding this testing service includes guidelines from national and international authorities, including:
Standards development organizations such as ASTM International and ISO/TC 210 provide guidance on test methods, specifications, and requirements. Standardization ensures consistency, reliability, and comparability of results across different laboratories.
USP <467> Residual Solvents Testing in Drug Substances is essential for ensuring product safety and efficacy. The presence of residual solvents can pose risks to human health, including:
This testing service is required by various industries, including:
The USP <467> test involves several steps:
1. Sample preparation: A representative sample of the drug substance is prepared according to the standard.
2. Instrumental analysis: The prepared sample is analyzed using gas chromatography or liquid chromatography coupled with mass spectrometry (GC-MS or LC-MS).
3. Data interpretation: Results are evaluated against established limits and guidelines.
Accurate testing requires:
The test report should include:
1. Test results: A detailed report of the residual solvent levels in the drug substance.
2. Method validation: Documentation of instrument calibration, method validation, and quality control measures.
3. Certification and accreditation: Evidence of laboratory accreditation and certification.
Benefits include:
1. Compliance with regulations: Ensures compliance with USP <467> and relevant national and international standards.
2. Quality assurance: Validates the safety and efficacy of drug substances by detecting residual solvents.
3. Risk assessment: Identifies potential risks to human health associated with residual solvent presence.
Eurolabs laboratory testing service offers:
1. Expertise: Highly trained and experienced personnel in USP <467> testing.
2. State-of-the-art equipment: Modern instrumentation for accurate and reliable results.
3. Accreditation and certification: Evidence of accreditation to international standards (ISO 17025:2017).
4. Quality management systems: Implementation of quality control procedures to ensure data integrity.
5. Competitive pricing: Offers a cost-effective testing service while maintaining technical accuracy.
Conclusion
USP <467> Residual Solvents Testing in Drug Substances is essential for ensuring product safety and efficacy. Eurolabs laboratory testing service provides accurate, reliable, and compliant results, ensuring compliance with regulatory requirements. By choosing Eurolab, companies can ensure their products meet the highest standards of quality and safety.
References
1. USP <467>: United States Pharmacopeia (2023). Residual Solvents in Pharmaceutical Products.
2. ISO 17025:2017: International Organization for Standardization (2020). General Requirements for the Competence of Testing and Calibration Laboratories.
3. ASTM E2609-19: American Society for Testing and Materials (2020). Test Method for Determination of Residual Solvents in Pharmaceutical Products.
Note: This document is a comprehensive guide to USP <467> residual solvents testing in drug substances and Eurolabs laboratory testing service. It aims to provide detailed information on the standard, testing procedures, and benefits of choosing Eurolabs services.