Articles
USP <1217> 'Tablet Breaking Force': A New Chapter For Tablet Hardness
February 20, 2008
The new USP chapter <1217> "Tablet Breaking Force" in USP 31 NF6 describes important concerns of tablet hardness testing users:
- Comparability of results obtained from constant loading rate measurements and constant plate movement measurements. Hardness test results may vary from plant to plant, country to country or between QC and IPC due to the existence of tablet hardness testers using one of these two measurement modes.
- Calibration of hardness testers shall be done on the complete measuring range. The detection limits have to be proven and therefore the new USP chapter requires a 3 point calibration. Even if the traceable counterweights are somewhat uneasy to handle a one point calibration is not enough.
- Tablet orientation especially for oblong shaped tablets, the position of the tablet during the measurement process is critical. The USP states that the position shall be "preferably one that is most readily and easily reproduced by operators." Orientating tablets on hardness testers can be time-consuming especially for complex shapes as well as small oblong tablets.
The measurement mode can be set in the configuration, introducing values for constant loading rate or constant plate movement e.g. 20N per sec or 1 mm per sec. The problem associated with comparability of results is thus eliminated as the new instrument can mimic the old one when necessary.
The Calibration can also be done on three points as required by the USP.
Finally the orientation of the tablet can be done automatically by the unique and patented Auto Alignment™ system with complete reproducibility.
To learn more about the SOTAX family of hardness testers, check us out at www.sotax.com/Hardness.116.0.html.
Source: SOTAX Corporation
