Title : Novel, efficient, facile, and comprehensive protocol for post-column amino acid analysis of icatibant acetate containing natural and unnatural amino acids using the QbD approach.

Pub. Date : 2019 Feb

PMID : 30327888






1 Functional Relationships(s)
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1 This approach was useful in meeting the method quality attributes [resolution (Rs) > 2.0; plate count (N) > 5600; and USP tailing factor < 1.2] with a target analytical method profile of relative amino acid mole ratios (RAAMR) in the range of 0.9-1.1 for Ser, Oic, Tic, Hyp, Ala (Thi), Gly and Pro, and between 2.7 and 3.3 for Arg. 2-acetyl-4(5)-tetrahydroxybutylimidazole pleckstrin and Sec7 domain containing 4 Homo sapiens