App Note Title: Improving Routine Analysis of Insulin Analogues Using the ACQUITY QDa Detector

1. Why is the USP method for insulin analysis not sufficient to meet the new FDA guidelines for biosimilars? (1 mark)
2. Why is m-creosol not seen in the MS chromatogram? What is the MW of m-creosol and what purpose does it serve in the finished product? (3 marks)
3. Which method has the lower detection limit? What information demonstrates this? (2 marks)
4. Are the three insulin peptides the same based on UV data? Are they the same based on MS data? What demonstrates that they are the same or different? What data supports your conclusions? (4 marks)