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The sudden appearance of an unknown peak during an HPLC analysis of a pharmaceutical product can be a critical finding causing delays and requiring considerable resources to resolve.
The unknown peak can be caused by many things ranging from simple sample preparation contamination, all the way to unexpected degradation/stability properties of the product.
It is essential that a rapid and effective investigation take place to quickly determine the identity of the anomalous peak and determine the root cause of its presence in the product.