Firms are requested to submit the following analytical data with each shipment:
- SAX-HPLC chromatograms
- The 500 MHz 1D-1H-NMR spectrum , which includes an expansion plot of the1.8 to 2.3 ppm region along with the full spectrum.
- The test methods for HPLC-SAX and NMR mentioned above are describe the following manuscript: J. Pharm. Biomed. Anal. 51 (2010) 921-926
This test method can also be referenced on FDA’s website at the following link: http://www.fda.gov/aboutfda/centersoffices/cder/ucm136991.htm