Separation type: Bridge Ion Separation Technology, or BIST™ by SIELC Technologies

Bivalirudin is a short, 21-amino-acid peptide.  It has 2 basic and 6 acidic groups. It is a naturally-occurring anticoagulant.  Asp⁹-bivalirudin is a process impurity and can be a result of the degradation of the drug bivalirudin.  SIELC’s new BIST™ mode can retain and separate Bivalirudin and its degredant with a TMDAP phosphate buffer, and the respective retention times can be controlled by altering the pH of the buffer.

BIST™ A+ Column 2.1x100mm 3um 100A

Condition

Column	BIST™ A+, 2.1×100 mm, 3µm, 100A
Mobile Phase	MeCN – 30%
Buffer	TMDAP phosphate – 10 mM  pH 5.0,  pH 6.0
Flow Rate	0.2 mL/min
Detection	UV 275 nm

Description

Class of Compounds	Drugs, Anticoagulant
Analyzing Compounds	Bivalirudin and Asp9 – bivalirudin is a process impurity