USP has published recommendations on replacing manual titration with autotitration for a wide range of pharmaceutical assays. This project was initiated by USP in collaboration with Metrohm to respond to current requirements regarding data integrity (ALCOA) and compliance (FDA 21 CFR part 11).
This implies that in order to ensure and improve regulatory compliance, you should consider switching to autotitration.
We have compiled a White Paper to help you to transition from manual to automated titration. In addition, we have written a second white paper to guide you through titration methods validation. Click below to get your copies.
Vil du vide mere? Download vores white paper
We have compiled a comprehensive white paper and several application documents that address typical questions that arise with the change from manual to automated titration. This white paper is intended to help follow the recommendations by USP.
... og hvad med metodevalidering?
Method validation of a titration ensures that the selected titration method and parameters provide a reliable and robust result. This second white paper gives guidance on titration methods validation, discussing titrant standardization, specificity, and much more.
Why changing to autotitration now?
- Ensure data integrity and regulatory compliance
- Improve result accuracy and reliability
- Ensure method validation and enable method transfer
- Save time and money through automation and increased lab throughput
Switching from manual to automated titraton: How to go about this?
Start the process today
Contact us now to initiate the process of updating your methods. Our product and application specialists will gladly support you, from instrument selection to application setup.
Rely on an expert partner
Metrohm looks back on decades of experience in manual and automated titration. We provide you with the fitting equipment and instruments for your application.
Ensure a long-term solution
Make sure your application and instrumentation works in the long run. For example, Metrohm offers a 3-year warranty on instruments and guarantees the availability of spare parts for 10 years.