Thermal Decomposition of Thonzonium Bromide

Authors: Chafetz, L.¹; Greenough, R.C.²; Frank, J.³

Source: Pharmaceutical Research, Volume 3, Number 5, 1 October 1986 , pp. 298-301(4)

Publisher: Springer

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Abstract:

Thonzonium bromide, a quaternary ammonium compound used as a surface active agent in a phenylephrine nasal solution, gave a gas chromatographic peak which was proportional in height and area to its concentration. Quaternary ammonium salts are nonvolatile and polar, thus the peak was attributed to a thermal decomposition product. It was identified as hexadecyldimethylamine by spectroscopic analysis and comparison with an authentic sample. A second product was identified by mass spectroscopy as 2[(2-hexadecylmethylaminoethyl)(4-methoxybenzylamino)] pyrimidine, the desmethyl bromide product. These decomposition products were detected in stability samples of formulations.

Keywords: thonzonium bromide, thermal decomposition; quaternary ammonium derivatives, gas chromatograph; surface active agents, nasal solutions; stability of nasal formulations

Document Type: Research article

Affiliations: 1: Product Development Laboratories, Warner-Lambert Research Institute, Morris Plains, New Jersey 07950. Chafetz Associates, P.O. Box 990, Murray Hill, New Jersey 07974. 2: Product Development Laboratories, Warner-Lambert Research Institute, Morris Plains, New Jersey 07950. 3: Product Development Laboratories, Warner-Lambert Research Institute, Morris Plains, New Jersey 07950. Deceased, 1978.

Publication date: 1986-10-01