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Ion-Pair Reversed-Phase LC Method Development for sgRNA Impurity Analysis Using Biozen Oligo Column
High-resolution impurity profiling of single guide RNAs (sgRNAs) is critical for ensuring CRISPR reagent quality, yet remains analytically challenging due to RNA length and structural complexity. This technote describes the development of a robust ion-pair reversed-phase LC-UV method for sgRNA purity assessment, with a focus on resolving closely related truncated impurities such as N-1 species. Using an Analytical Quality by Design (AQbD) approach aligned with ICH Q14 principles, critical method parameters were systematically identified and optimized through risk assessment and design of experiments. Implemented on a Biozen Oligo column, the final method delivers reproducible, high-resolution separation suitable for routine sgRNA analysis in both development and QC environments.
Ion-Pair Reversed-Phase LC Method Development for sgRNA Impurity Analysis Using Biozen Oligo Column
High-resolution impurity profiling of single guide RNAs (sgRNAs) is critical for ensuring CRISPR reagent quality, yet remains analytically challenging due to RNA length and structural complexity. This technote describes the development of a robust ion-pair reversed-phase LC-UV method for sgRNA purity assessment, with a focus on resolving closely related truncated impurities such as N-1 species. Using an Analytical Quality by Design (AQbD) approach aligned with ICH Q14 principles, critical method parameters were systematically identified and optimized through risk assessment and design of experiments. Implemented on a Biozen Oligo column, the final method delivers reproducible, high-resolution separation suitable for routine sgRNA analysis in both development and QC environments.
Document Type:
Technical Notes
Target Industries:
Techniques:
Brands:
Separation Modes:
Reversed Phase
Phases:
Ion-Pair Reversed-Phase LC Method Development for sgRNA Impurity Analysis Using Biozen Oligo Column
High-resolution impurity profiling of single guide RNAs (sgRNAs) is critical for ensuring CRISPR reagent quality, yet remains analytically challenging due to RNA length and structural complexity. This technote describes the development of a robust ion-pair reversed-phase LC-UV method for sgRNA purity assessment, with a focus on resolving closely related truncated impurities such as N-1 species. Using an Analytical Quality by Design (AQbD) approach aligned with ICH Q14 principles, critical method parameters were systematically identified and optimized through risk assessment and design of experiments. Implemented on a Biozen Oligo column, the final method delivers reproducible, high-resolution separation suitable for routine sgRNA analysis in both development and QC environments.
| Target Industries: | Biopharmaceutical Analysis |
| Techniques: | HPLC, HPLC Reversed Phase, Oligonucleotide Analysis |
| Brands: | Biozen LC |
| Separation Modes: | Reversed Phase |
| Phases: | Biozen-Oligo |
Phenomenex is a technology leader committed to developing novel analytical chemistry solutions that solve the separation and purification challenges of researchers worldwide.
Phenomenex is a technology leader committed to developing novel analytical chemistry solutions that solve the separation and purification challenges of researchers worldwide.