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Manufacturing Troubleshooting

Even well-defined pharmaceutical processes can grind to a halt when an unexpected HPLC peak arises during product quality control testing. We have the capabilities (high resolution MS, GCMS, NMR) and experience to investigate and unequivocally identify unexpected impurities with speed and precision.

Case Study: Unknown Impurity in Drug Product

A client was faced with production shutdown when an unexpected impurity arose in its QC testing of an oligopeptide product. We determined that the impurity was in fact API-related, and arose as a consequence of reaction with trace acetaldehyde leaching into the manufacturer’s equipment train. Once the source was identified and remedied, production resumed without problem.