Vitamin K1
- CAS number
- 81818-54-4
- Application
- Phytonadione (vitamin K1) is a medication used to treat and manage vitamin K deficiency, which is a significant risk factor for intracranial hemorrhage and other bleeds.
- Molecular weight
- 450.7 g/mol
- Molecular formula
- C31H46O2
- 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.
How to initiate a quotation request and a supplier qualification within your quality system?
