Agilent develops method for elemental impurity analysis in synthetic oligonucleotides
Agilent Technologies has introduced a new method for analyzing elemental impurities in synthetic oligonucleotides using ICP-MS technology. The method adheres to industry regulatory standards.
Agilent Technologies has developed a method for the analysis of elemental impurities in synthetic oligonucleotides. The method utilizes the Agilent 7850 ICP-MS instrument and aligns with guidelines set by the United States Pharmacopeia (USP) and the International Council for Harmonisation (ICH).
Synthetic oligonucleotides are short chains of DNA or RNA molecules used in applications such as PCR tests, DNA sequencing, and novel therapeutic products. Their manufacturing processes, along with environmental factors and packaging, can introduce inorganic impurities that affect product safety. While oligonucleotide products are not yet explicitly included in all regulatory guidelines, industry best practice is to follow these standards.
The developed workflow evaluates the accuracy, specificity, reproducibility, and ruggedness of the analytical method. Experimental results demonstrated the method's suitability for routine analysis, including stability and detectability for various elements.
The use of the Agilent 7850 ICP-MS offers a reliable and efficient way to ensure the safety and quality of synthetic oligonucleotides, addressing the increasing need for precise elemental impurity monitoring in the pharmaceutical and biotechnology sectors.