Profiling Metal Content In Parenteral Grade Protein Stabilizers

Sucrose, Trehalose, Mannitol, and Maltose are four of the most commonly utilized carbohydrates for protein stabilization in drug formulations. As the demand for parenteral excipients continues to rise, the biopharma industry is considering guidance that would require more extensive analysis of a variety of minor constituents, including metals. 

Despite the high purity of many of these excipients, it is important for manufacturers to have an understanding of non-sugar moiety profiles and how they may vary with raw materials and processing. Herein, we present results of validated metal analysis performed on Pfanstiehl’s injectable grade platform excipients. Specifically, multiple lots each of trehalose, sucrose, mannitol, and maltose were tested for levels of V, Cr, Mn, Fe, Ni, Cu, Zn, As, Mo, Ru, Rh, Pd, Cd, Os, Ir, Pt, Hg, and Pb. Observations from the data and proposed next steps are discussed.