Acceptable RSD-Limit as SST for finished products
Posted: Thu Oct 11, 2012 7:58 am
Ph. Eur. indicates SST repeatability limits in chapter 2.2.46, table 1. However, in case of finished products the upper specification limit is usually 105% and therefore B=5. But in the table no requirements are defined for B=5
Can I calculate the limits for B=5 or does anyone have an other approach how I can define an appropriate SST limit for a HPLC method, which has shown a repeatability (RSD) of 0.8% during method validation?
Thank you guys!
Can I calculate the limits for B=5 or does anyone have an other approach how I can define an appropriate SST limit for a HPLC method, which has shown a repeatability (RSD) of 0.8% during method validation?
Thank you guys!