Crystal structure and solid-state studies of aged samples of tienoxolol, an API designed against hypertension
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10.1016/j-ijpharm.2011.10.025
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hdl:2117/14578
Tipus de documentArticle
Data publicació2012
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Abstract
Aging of drug molecules is generally studied following regulatory procedures, i.e. under forced conditions
and for relatively limited storage time; therefore naturally aged samples are rare and provide scientific
reference data beyond regulatory considerations. Tienoxolol was studied after 25 years of storage in
the dark under ambient conditions. About 86% of the samples still consisted of tienoxolol and the main
impurity (13%) was caused by the hydrolysis of the ester moiety. Protection from humidity is therefore
important. Other sensitive groups containing nitrogen and sulfur appear to be quite stable with less
than 0.8% conversion over 25 years. In addition, the crystal structure has been solved. Tienoxolol orange
needles were found to crystallize in the orthorhombic non-centrosymmetric space group Iba2, indicating
that the crystal is a racemic compound. The unit cell parameters at room temperature are a = 10.069(5)A˚ ,
b = 45.831(10)A˚ , and c = 9.822(5) ˚A and the unit cell volume is 4533(3) ˚A3 with Z = 8.
© 2011 Elsevier B.V.
CitacióMahé, N. [et al.]. Crystal structure and solid-state studies of aged samples of tienoxolol, an API designed against hypertension. "International journal of pharmaceutics", 2012, vol. 422, núm. 1-2, p. 47-51.
ISSN0378-5173
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