Iron-containing active substances commonly used in the treatment of iron deficiency usually contain a mixture of Fe³⁺ and Fe²⁺. Free Fe²⁺ plays a key role in the formation of harmful hydroxyl radicals via reactive oxygen species and is therefore a critical parameter that must be tightly controlled in pharmaceutical formulations.
In this context, the Turkish Medicines and Medical Devices Agency (TİTCK), in line with the USP–NF Iron Sucrose Injection monograph, requests the use of the polarography method for the determination of free iron (II) in iron-containing finished products.
Do you need polarography for your free Fe(II) analyses?
At the WMINOLAB Innovation Laboratory, with our polarograph instrument and in accordance with ICH Q2(R1) and USP <801> guidelines, we offer:
- Specification testing in finished products and raw materials containing iron (III),
- Free Fe(II) determination in APIs, finished products and excipients,
- Analytical method validation and routine testing.
We serve as your solution partner in our fields.
To benefit from our analytical services and obtain more detailed information, you can contact us via our website or by e-mail at wminolab@worldmedicine.com.tr.