Tramadol hydrochloride.

Robert Smyj, Xiao-Ping Wang, Feixue Han

Apotex Inc., Toronto, Ontario, Canada.

Profiles of drug substances, excipients, and related methodology 2013

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A profile of the analgesic tramadol hydrochloride ((1RS,2RS)-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl)cyclohexanol hydrochloride) is provided in this chapter and includes a summary of the physical characteristics known for this drug substance (e.g., UV/vis, IR, NMR, and mass spectra). Details regarding the stability of tramadol hydrochloride in the solid state and solution-phase are presented and methods of analysis (compendial and literature) are summarized. Furthermore, an account of biological properties and a description of the chemical synthesis of tramadol hydrochloride are given. Copyright © 2013 Elsevier Inc. All rights reserved.