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ABSTRACT
| Title |
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Stability Study of Hydralazine HCl Oral Solutions Compounded in Humco Oral Vehicles to Determine a Beyond-use Date |
| Authors |
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Pradeep Gautam MS, Troy Purvis |
| Keywords |
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Hydralazine Hydrochloride, Versa FreeTM, Humco, Sorbitol 70%, Oral Solution, Pediatric Use |
| Issue Date |
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Jun 2017 |
| Abstract |
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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) |
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118-124 |
| ISSN |
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0975-9492 |
| Source |
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Vol. 8, No.06 |
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