Chemistry Reference
In-Depth Information
8. Current Good Manufacturing Practice for Finished Pharmaceuticals, 21 CFR Part 211,
http://www.fda.gov/cder/dmpq/cgmpregs.htm.
9. International Organization for Standardization, http://www.iso.org/iso/home.htm.
10. Reviewer Guidance, Validation of Chromatographic Methods, USFDA (November 1994)
http://www.fda.gov/cder/guidance/cmc3.pdf.
11. Snyder, L. R., Kirkland, J. J., and Glajch, J. L.
Practical HPLC Method Development
,
2nd ed., Wiley-Interscience, New York, 1997.
