( absorbance of Costar wells containing ...)Using the SpectraMax Plus for USP Dissolution Calibration (MaxLine Application Note #27)

absorbance of Costar wells containing water is approximately .039 to .049 OD. Thus, for samples having raw absorbance values of 1 OD, the worst-case mismatch between plates would still produce an error of 1% or less. However, the lower the absorbance values of the samples, the greater the maximum potential error due to plate variability. The variability is considerably higher at 242 nm, where the average absorbance is approximately .090 OD, and the standard deviations range from .002 to .015 OD. If you decide to use Costar UV plates with stored pre-read values, potential error can be minimized by analyzing all samples and standards in duplicate or triplicate.

CALIBRATION TEST OF USP APPARATUS 2
To illustrate the performance of the SPECTRAmax PLUS, two 6-paddle (Apparatus 2) dissolution systems were tested using USP disintegrating (prednisone) calibrator tablets. The tests were performed according to the specifications in USP <711> and the instructions on the certificate accompanying the calibrator. The absorbances of the standards and samples were read in a microplate format using SOFTmax PROs PathCheck feature to normalize the absorbance values to a 1 cm pathlength. The resulting data were analyzed using custom formulas written in SOFTmax PRO.

Experimental details
To make the standards, a stock solution of USP Prednisone reference standard was prepared in water containing 5% alcohol. Aliquots of the stock were diluted with water to give final working standard concentrations of 5, 10, 20, 30, 40 and 50 g/mL.

The USP calibrator tablets were Prednisone, 50 mg, Lot L. Two dissolution systems (A and B) with 6 vessels each were tested. Each vessel was tested with one calibrator tablet in 900 mL deaerated deionized water at 37C with a paddle speed of 50 RPM. Samples were collected promptly at 30 minutes, filtered, and refrigerated until analysis.

In SOFTmax PRO, a Plate section was created wi
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