The client had developed an in house HPLC-UV method to carry out the analysis for impurities of a well-known generic antibiotic API it was planning on manufacturing. The analytical method with supporting data was included in its ANDA submission to the FDA.
In response to the initial submission, the FDA’s review sought additional data. As well as a request for a comparative study to the then current USP monograph method for the API and its impurities to demonstrate equivalence.
The USP method employed the use of a dual electrode coulometric detector. An HPLC method with coulometric detection can be extremely troublesome and challenging to use, especially on a routine basis. Such a method requires a significant amount of experience and expertise with this specific detector which is why the client had developed an alternate method employing HPLC-UV.
Having extensive experience using complex or unique analytical methodology, Quantum was hired to develop the data for the client’s submission. Initially, the client’s method was transferred to Quantum, through a protocol developed by Quantum.
Once successfully transferred, a side by side comparison between the client’s method and the USP method was performed. At the completion, a report in submission-ready format was provided to the client. Shortly after Quantum’s submission of the additional data requested by the FDA, the client received approval of their ANDA submission.