Physical and Chemical Stability of Estriol 0.025% to 1% Vaginal Creams (VersaBase)

Ip, K.; Shan, A.; Yan, W.; Banov, D.

International Journal of Pharmaceutical Compounding 22(6): 504-511

2018


ISSN/ISBN: 1092-4221
PMID: 30384351
Accession: 065879243

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Abstract
Estrogen replacement therapy is often recommended when female patients present with lower than normal physiologic levels, such as patients going through menopause. The physical and chemical stability of estriol 0.25 mg/g and 10 mg/g vaginal creams (VersaBase) was tested over a period of 182 days, at room temperature and refrigerated conditions, in order to determine the corresponding beyond-use date. The physical characterization consisted in observing all samples for color/appearance and odor, and testing for pH, whereas the chemical characterization consisted in ultra-performance liquid chromatography assay testing. Both vaginal creams were proven physically and chemically stable, and the ultra-performance liquid chromatography method was proven stability indicating. As a result, the beyond-use date of the estriol 0.025% to 1% vaginal creams (VersaBase), in electronic mortar and pestle plastic jars, is six months at both room temperature and refrigerated conditions.