Peptides & Proteins

CANTEST has provided peptide manufacturers with regulatory compliant services for almost ten years. ICPMS is particularly well-suited to this new class of compounds due to the inherently high sensitivity of the technique, enabling quantitative measurements of impurity metals in the 0.01-1 µg/g range. A full trace impurity scan of a production batch may be performed with as little as 5 mg of submitted sample. Some more specific assays include the following:

•  “Heavy Metals”: in many situations, older techniques, such as USP<231>, are inadequate both chemically, due to interferences, and financially, due to sample quantities required for a single test. ICPMS is a far superior alternative, offering selective and sensitive quantitation of these analytes using milligrams of sample rather than grams.
• Residual Catalysts: metal catalysts, such as Palladium, are used in the chemical processing of many active substances and excipients, including peptides. There are guidelines now in place (e.g. EMEA CPMP/ SWP/ QWP/ 4446/ 00) to regulate the levels of 14 different elements in final drug products, including precious metals (e.g. Pd, Pt, Ir, Rh, Ru and Os) and transition metals (e.g. V, Cu, Ni, Cr, Mn, Zn and Fe).
• Residual Solvents: unwanted compounds in the final drug product, such as tri-fluoroacetate, can be separated effectively and quantified by ion chromatography with conductivity detection.

CANTEST also offers molecular weight determinations via LC-MS for certain classes of compounds, as well as compound purity assessments via diode array or mass spectral detection.