Development and Validation of a Headspace GC–MS Method for Simultaneous Quantification of Antimicrobial Preservatives in Biopharmaceutical Peptide Formulations

ABSTRACT The four most used antimicrobial preservatives in biopharmaceutical parenteral formulations are phenol, meta‐cresol, chlorobutanol, and benzyl alcohol. Preservatives are included in various combinations in biopharmaceuticals highlighting the importance of an analytical method to quantify the four preservatives simultaneously. A headspace GC–MS method was developed to quantify phenol, chlorobutanol, meta‐cresol, and benzyl alcohol. The method was validated according to USP . System suitability was conducted daily for retention time (%RSD