Table III.

Stability and Dissolution Profiles of Test Formulation Following Storage at Room Temperature and Accelerated Conditions

Parameter	Initial	25°C ± 2°C/60% ± 5% RH			40°C ± 2°C/75% ± 5% RH
		1 month	2 months	3 months	1 month	2 months	3 months
Assay (mg)	40.34	40.12 ± 0.39	40.01 ± 0.47	39.76 ± 0.55	40.03 ± 0.51	39.87 ± 0.59	39.54 ± 0.66
Diastereoisomer I	0.07	0.07 ± 0.01	0.07 ± 0.02	0.07 ± 0.01	0.07 ± 0.02	0.07 ± 0.02	0.07 ± 0.02
Diastereoisomer II	0.03	0.03 ± 0.01	0.03 ± 0.01	0.03 ± 0.01	0.03 ± 0.01	0.03 ± 0.01	0.03 ± 0.02
Diastereoisomer III	0.09	0.09 ± 0.02	0.09 ± 0.02	0.09 ± 0.02	0.09 ± 0.01	0.09 ± 0.03	0.09 ± 0.03
Single unknown maximum (M)	0.18	0.18 ± 0.01	0.18 ± 0.01	0.18 ± 0.02	0.18 ± 0.01	0.18 ± 0.02	0.18 ± 0.02
Total impurities	0.37	0.37 ± 0.02	0.37 ± 0.02	0.37 ± 0.02	0.37 ± 0.02	0.37 ± 0.03	0.37 ± 0.03
% Dissolved drug at 30 min (in 2.2% SDS)	99.30	99.02 ± 3.38	98.27 ± 2.94	99.46 ± 4.21	98.15 ± 5.22	98.43 ± 4.27	98.03 ± 4.83