Iron-containing active ingredients are commonly used in the treatment of iron deficiency, containing both iron (III) and iron (II). Free iron (II) is a key element in mediating the conversion of harmful hydroxyl groups. Because of their potential to pose a risk to patient health, iron-containing products are subject to strict controls.
The current USP-NF Iron Sucrose Injection monograph recommends a Polarographic method for the determination of free Iron (II) and low molecular weight iron [Iron (II) and Iron (III)] complexes.
In our laboratory, we perform free Iron (II) analysis in API, finished product and other excipients with the polarography device in accordance with ICH Q2 and USP <801> guidelines.