【讨论】why-dissolution-test-apparatus-calibration-salicylic-acid-tablets-sto...

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Prednisone and Salicylic acid tablets USP were used for the calibration of
dissolution test apparatus. Prednisone tablets were disintegration type and
Salicylic acid tablets were non-disintegration type.
Dissolution test apparatus calibration is described in General Chapter
DISSOLUTION <711> but the calibration with Salicylic acid tablets USP is no
longer available now because USP had withdrawn the Salicylic acid calibration
part on December 01, 2009.
FDA published the change in dissolution test apparatus calibration in January
2010 in cGMP guideline for calibration of dissolution apparatus while USP
published a toolkit for calibration for the dissolution test apparatus in March
2010 describing the dissolution test apparatus calibration procedure only with
Prednisone tablets. But FDA and USP does not describe the requirement for the
change.
Following are some possible reasons for the withdrawal of Salicylic acid tablets
from the dissolution test apparatus calibration.
1. Salicylic acid tablets were non-disintegrating and uncoated tablets but
practically uncoated and non-disintegrating formulations are very rare, so there
was no requirement for the calibration the dissolution apparatus with the non
disintegrating tablets.
2. Salicylic acid tablets are unstable and stuck together. Due to this, these
tablets violates the quality of analytical standard.
Therefore the Salicylic acid tablets had withdrawned from the calibration of
dissolution test apparatus.