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Does a monograph in the EP cover colorants used in the manufacture of rigid plastic containers?

April 15, 2008
Question 

Is there a monograph in the European Pharmacopeia that covers colorants used in the manufacture of rigid plastic containers to contain pharmaceuticals?

Answer 

There are certain colorants (e.g., titanium dioxide) listed in monographs that cover particular types of plastics used in pharmaceutical packaging applications, such as the monograph on polyolefins; however, there is no specific monograph in the European Pharmacopoeia (EP) dedicated to colorants used in rigid plastic containers. This does not mean that colorants may not be used in plastic packaging for pharmaceuticals. Indeed, the preamble to the EP general chapter on containers explicitly states that materials and polymers other than those described in the pharmacopoeia may be used subject to appropriate case-by-case approval from the competent authorities responsible for the licensing for sale of the preparation in the container. If you would like assistance in determining the status of a particular colorant for use in a given pharmaceutical application, please feel free to contact us.