Analysis of Biopharmaceutical Lyophilizate Residual Moisture by Karl-Fischer Titration (KFT) (CAT#: STEM-B-0414-CJ)

KFT is based on a technique developed by Karl Fischer, a German chemist in the 18th century. It is performed by adding a solution containing iodine and sulfur oxide of known concentrations to the lyophilized product. In presence of a base and an alcohol, the Karl Fischer reaction occurs under the consumption of water and iodine in a 1:1 molar ratio. When all water molecules are consumed, the excess iodine is quantified by a detector electrode, allowing for a calculation of the water content. And KFT is an extremely accurate technique for residual moisture determination and in general not influenced by the excipients in the freeze-dried drug product.

Biopharmaceutica

1. Sample preparation.
2.The sample is dissolved in KF methanol and the iodine is added to KF Reagent.
3. The endpoint is detected potentiometrically. (Coulometric determination)

• Sample: Proteins, Peptides, Nucleic acids, Naturally-occurring compounds & more
• Equipment: Karl Fischer titrators

Compared to the orthogonal technique of headspace moisture analysis [HMA], KFT does not rely on reference standards for quantification. Thus, method development is reduced to a minimum. However, KFT is a destructive technique.