At PreciseMol Solutions, our Extractables & Leachables (E&L) testing solutions are designed to ensure the safety, compliance, and reliability of pharmaceutical packaging and products. We provide comprehensive support to help you identify, quantify, and control potential contaminants that could impact drug safety and efficacy. Our expertise, precision, and regulatory alignment make us a trusted partner for global pharmaceutical companies. Here’s what sets our E&L services apart:
🧪 Comprehensive E&L Standards – We offer a wide range of reference materials for extractables and leachables testing, covering common packaging materials, excipients, and formulation components.
🔬 Regulatory-Compliant Solutions – All our E&L standards and protocols are developed according to ICH, FDA, and EMA guidelines, ensuring your studies meet global regulatory expectations.
⚗️ Customizable Reference Materials – Our team can design and provide specific standards tailored to your unique packaging, formulation, or analytical requirements for targeted E&L studies.
📊 Robust Analytical Characterization – Each standard is supported by complete analytical data, including NMR, LC-MS, GC-MS, and HPLC, ensuring accurate and reproducible results.
🧩 Process-Related Impurity Support – We identify and provide reference materials for potential impurities arising from packaging, processing, or storage conditions to improve study reliability.
🚀 Rapid Turnaround & Delivery – Our agile operations allow fast preparation and delivery of E&L standards without compromising quality or regulatory documentation.
🤝 End-to-End Scientific Guidance – From method selection to data interpretation, our experts provide continuous support, ensuring your E&L testing is accurate, efficient, and compliant.
🌍 Global Client Trust – Pharmaceutical companies worldwide rely on our E&L solutions for packaging safety assessments, regulatory filings, and internal quality control.
⚙️ ISO-Compliant Quality Systems – Our manufacturing and analytical processes adhere to ISO standards, providing traceable, audit-ready E&L reference materials.
💡 Innovation & Flexibility – We continuously expand our E&L portfolio and analytical capabilities, helping clients tackle emerging challenges in packaging safety and regulatory compliance with confidence.