Betahistine hydrochloride

Betahistine hydrochloride

CAS number
5579-84-0
Application
Betahistine Hydrochloride is the hydrochloride salt form of betahistine, a histamine analog.
Molecular weight
209.116 g/mol
Molecular formula
C8H12N2.2ClH
Routes
Oral

SOCOSUR PDE monographs are a quick and efficient way to obtain:

  • Risks identification
  • Identification of potential critical effects
  • Rationale for NOAEL values selection
  • Complete description of adjustment factors F1 to F5 as well as PK correction
  • Complete review of all relevant pharmaceutical and medical databases, public or private, European or not in accordance with EMA guideline EMA/CHMP/CVMP/SWP/169430/2012, signed by an European toxicological expert with full CV

Benefits of such PDE monograph

A 16 to 25 pages report optimized in case of Regulatory Body inspection with all calculation details and all bibliographic references linked to these calculations.

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