ISSN : 0975-9492


Open Access

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Title : Stability Study of Hydralazine HCl Oral Solutions Compounded in Humco Oral Vehicles to Determine a Beyond-use Date
Authors : Pradeep Gautam MS, Troy Purvis
Keywords : Hydralazine Hydrochloride, Versa FreeTM, Humco, Sorbitol 70%, Oral Solution, Pediatric Use
Issue Date : Jun 2017
Abstract :
Hydralazine HCl was compounded into three formulations, at two concentrations 1 mg/mL and 10 mg/mL, using Humco’s oral compounding vehicles, and these formulations were evaluated for physical, chemical, and microbiological stability over a period of 9 weeks, in order to determine a beyond-use-date (BUD). The samples were stored at controlled room temperature (25 °C and 60% RH) and controlled cold temperature (2 – 8 °C), and after compiling the results for these samples over the time period, it was concluded that the samples compounded in Versa FreeTM and 70% Sorbitol Solution (both 1 and 10 mg/mL) and Versa FreeTM with 1% Carrageenan (10 mg/mL) were stable for at least 63 days when kept refrigerated. The 10 mg/mL Hydralazine HCl room temperature samples compounded in Versa FreeTM, 70% Sorbitol Solution, and Versa FreeTM with 1% Carrageenan were also stable for at least 63 days.
Page(s) : 118-124
ISSN : 0975-9492
Source : Vol. 8, No.06