Solkane®227 pharma specifications now standard
Solkane®227 pharma has recently been reviewed and approved by the US FDA for use in a MDI formulation as propellant.
Since it is the first HFC227 pharma propoellant approved by the FDA the Solkane®pharma specification is - according to the FDA - now the standard for all future drug products in the USA that uses HFC227 pharma.
As a result of this 2006 FDA review of the Solvay Apaflurane Drug Master File ( USA DMF no. 10099) in the United States Solvay Fluor GmbH is going to file a European ' Pseudo Variation' application for proposed changes to the Solkane® pharma specification and analytical methods used in order to harmonize its HFA 227 specifications worldwide.
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