characterization of parenteral iron preparations
by quantification of matrix-related intrinsic coloration in parenteral iron preparations
Parenteral iron preparations are used to treat iron deficiency.
These may cause hypersensitivity reactions due to their active ingredient or other components in the drug product.
With reference to the recommendation of the European Medicines Agency (EMA), these iron preparations are therefore under special observation.
The correct characterization of these preparations is therefore an inevitable aspect in the development and implementation of analytical methods.
The selectivity of photometric methods is negatively affected mainly caused by intrinsic color of the sample matrix.
However, the quantification of this intrinsic color selectively and directly is impossible in such iron products due to the strong intrinsic color of the complex iron present.
The matrix-related intrinsic color can only be quantified if the color originating from the various iron complex and the dissolved iron ions in the measuring solution are completely eliminated.
After the elimination of all color originating from iron, the photometric result obtained, corresponds to the matrix, and can be directly integrated into the evaluation of any photometric method.
Significant matrix-related coloration occurs in iron sucrose (FeSuc) preparations, while iron carboxymaltose (FCM) preparations show virtually none:
Red line = FeSuc preparation, blue line = FCM preparation (measuring concentration 5.6 µmol iron/ml each, reference water)
Likewise, significantly different intrinsic coloration is evident in different FeSuc preparations:
Red line, blue line, green line = different batches of various FeSuc preparations (measurement concentration 5.6 µmol iron/ml each, reference water)
This new methodology for quantifying matrix-related coloration thus contributes to a more complete and optimized characterization of parenteral iron preparations.
