Residual solvents—volatile organic compounds left after drug manufacturing—pose a unique challenge for pharmaceutical scientists. Meeting USP <467> standards for safety and quality requires precision, speed, and consistency. Yet, outdated equipment, space limitations, and the rising cost of helium often make this a time-consuming process.
What if you could depend on a streamlined process that delivers reproducible results, even when switching carrier gases or managing complex solvent classes?
Steps for USP <467> Compliance
A recent Agilent application note provides a clear framework for implementing reliable residual solvent analysis in pharmaceutical labs. This resource includes:
- Steps to meet USP <467> standards using helium or hydrogen carrier gases with reproducible accuracy.
- Methods to enhance detection and quantification of Class 1 and Class 2 solvents, including challenging compounds such as benzene.
- Practical strategies for improving workflow efficiency with the compact Agilent 8850 GC-FID System and Agilent 8697 Headspace Sampler tailored for process monitoring.
Residual Solvent Testing Solutions
Many labs rely on dedicated GC systems to minimize cross-contamination and ensure accurate residual solvent testing in pharmaceutical manufacturing. But as workflows grow more complex and lab space becomes limited, the rise of compact, high-performing systems is set to transform how labs ensure reliable results.
This application note presents proven methods for residual solvent analysis in real-world conditions, including offline and at-line testing environments. It offers detailed guidance on maintaining consistent signal-to-noise performance, achieving precise retention times, and improving solvent quantification workflows to meet regulatory and operational demands.
Complete the form to download your copy and keep your lab ahead in compliance and accuracy.
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