Analytical method development
The professional quality control laboratory of Ribobay has a full set of advanced analysis and testing instruments, which can meet various tests of oligonucleotides. The QC team has many years of experience in method development , and according to the different needs of customers for oligonucleotide products, we can complete the development of various analysis methods quickly.
Sequencing
To ensure the accuracy and completeness of the sequence, we sequence the sequences of oligonucleotide products or impurities by the LC-MS/MS method .
Method transfer and validation
For the analysis method developed by the partner, it can be transferred to the laboratory of Ribobay, go on the verification and validation according to the method transfer scheme. For the methods we develop, the methods will be verified in accordance with the requirements of national pharmacopoeia and relevant laws and regulations, such as: specificity, limits of quantitation, accuracy, linearity, durability, etc. If you need to transfer the method to your own laboratory, we will also cooperate with you to generate a plan and coach you to complete the method transfer.
Attributes | Method |
Appearance | Visual |
Water content | Karl Fischer |
pH value | pH meter |
Tm Value | UV |
Sodium counter ion | ICP-OES |
Sequencing | UPLC-MS/MS |
Molecular weight | UPLC-MS |
Assay | HPLC |
Related substances | IEX-HPLC |
Residual solvents | GC/HPLC |
Elemental impurity | ICP-MS |
Endotoxin | LAL |
Microbial limit | Membrane filtration |