Stability of propylthiouracil in extemporaneously prepared oral suspensions at 4 and 25 degrees C.
The stability of propylthiouracil in two extemporaneously prepared suspensions at 4 and 25 degrees C was studied. Commercially available 50-mg propylthiouracil tablets were used to prepare suspensions in 1:1 Ora-Sweet:Ora-Plus and in 1:1 1% methylcellulose:Simple Syrup, NF, to yield a propylthiouracil concentration of 5 mg/mL. Each suspension was stored in 10 amber plastic prescription bottles, 5 of them at 4 degrees C and the other 5 at 25 degrees C. Three samples were taken from each bottle at 0, 7, 14, 28, 42, 56, 70, and 91 days for assay by stability-indicating high-performance liquid chromatography. More than 90% of the initial propylthiouracil concentration was retained in both suspensions for 70 days at 25 degrees C and for 91 days at 4 degrees C. There were no changes in physical appearance, color, or odor, and the pH remained essentially unchanged. Propylthiouracil 5 mg/mL in two extemporaneously prepared oral suspensions was stable for at least 70 days at 25 degrees C and for at least 91 days at 4 degrees C.
Ohio State University, Columbus 43210, USA.
M C
MC
Nahata
R S
RS
Morosco
J M
JM
Trowbridge
D013956:Antithyroid Agents; D002626:Chemistry, Pharmaceutical; D002851:Chromatography, High Pressure Liquid; D004355:Drug Stability; D004356:Drug Storage; D006801:Humans; D007223:Infant; D011441:Propylthiouracil; D013535:Suspensions; D013696:Temperature
D013956:Antithyroid Agents; D013535:Suspensions; D011441:Propylthiouracil