Insulin porcine

CAS number
12584-58-6
Application
Insulins and analogues for injection, fast-acting
Molecular weight
5794 g/mol
Molecular formula
C256H381N65O77S6
Routes
Intravenous

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.

How to initiate a quotation request and a supplier qualification within your quality system?