Analysis of Tris (Hydroxymethyl) Aminomethane in Oligonucleotide Active Pharmaceutical Ingredient (API) Using Ion Chromatography

User Benefits

- Simultaneous separation of tris (hydroxymethyl) aminomethane and general inorganic cations using ion chromatograph can be performed by addition of two types of crown compounds to the eluent. - The elution time can be shortened by adding acetonitrile to the eluent containing two different crown compounds.

Introduction

In recent years, there is increasing importance of quality control for medium-molecular-weight drugs involving oligonucleotide therapeutics according to their development progress. Tris (hydroxymethyl) aminomethane (referred to as Tris hereinafter) is a common component in buffer solutions used in life sciences and plays an important role in the manufacturing process of oligonucleotide therapeutics. However, its absence in final product is preferred because it is considered an impurity. Verification of residual Tris levels may be required from a pharmaceutical quality assurance perspective whereas it is not regulated yet. Currently, analytical methods for Tris are limited and titration method is often used. However, this method is not suitable for precise quantification of trace amounts of target compounds. Furthermore, solutions containing cations such as sodium in addition to Tris are commonly used in oligonucleotide synthesis and manufacturing processes. Therefore, simultaneous separation of Tris and these coexisting cations is preferable for accurate and reliable quantification. This article introduces analysis of Tris using ion chromatography.

March 24, 2026 GMT