Stability of XXXX Preservative-Free Oral Solutions.

@entity3736 @entity1 @entity701 @entity19299
OBJECTIVES: The physical and chemical stability of a preservative-free oral solution of @entity19299 was studied at different pH values and storage temperatures. METHODS: Oral solutions of @entity701 1 mg/mL were prepared by dissolving @entity19299 powder in @entity3736 buffers at pH 4.0, 5.5, and 6.5, or with sterile water (pH 7.4) stored in amber glass vials. Three identical samples of the formulations were prepared and stored under refrigeration (3-7  C), ambient temperature (20-22  C) and high temperature (29-31  C). A 200- L sample was withdrawn from each of the 3 samples immediately after preparation and at 1, 7, 14, 21, and 35 days. Samples were assayed in duplicate using stability-indicating liquid chromatography. Stability was determined by evaluating the percentage of the initial concentration remaining at each time point; stability was defined as the retention of at least 90% of the initial concentration of @entity19299 . RESULTS: At least 92% of the initial @entity19299 concentration in solutions pH 5.5, 6.5, and 7.4 remained throughout the 14-day study period under refrigeration. There were no detectable changes in color, odor, or pH and no visible microbial growth in these samples. In other storage conditions, @entity19299 was rapidly degraded. CONCLUSIONS: The @entity19299 preservative-free oral solutions at pH 5.5, 6.5, or 7.4 are chemically stable when stored under refrigeration for at least 14 days. They provide flexible and convenient dosage forms without any preservatives for pediatric @entity1 .
