Contaminant in Veterinary Antibiotic

A common issue in pharmaceutical analysis is the appearance of extraneous peaks in HPLC-UV chromatograms. In a recent case a customer detected an unknown peak in the chromatogram of a veterinary antibiotic API.

Background

A common issue in pharmaceutical analysis is the appearance of extraneous peaks in HPLC-UV chromatograms. In a recent case, a customer detected an unknown peak in the chromatogram of a veterinary antibiotic API.


Approach and Results

The first stage was to replicate the customer method in-house and match the chromatographic profiles of the problem samples. However, the extraneous peak was not observed in-house. After discussion, the samples were prepared for analysis by the customer and the vials shipped to RSSL for analysis. These samples did contain the extraneous peak. The method was transferred to LC-MS where the contaminant was identified as a long fatty alcohol ethoxylate. Swabs and extracts of equipment used at the customer site were taken and subsequent analysis indicated that glass pipettes contained this residue.

Root cause analysis indicated that the pipettes were not being adequately rinsed after cleaning. Corrective and preventative actions were implemented.

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