Analytical
Home | Services & Solutions | Oligonucleotide | Development & Manufacturing | Analytical
WuXi TIDES boasts a dedicated team of scientists specialising in oligonucleotide analysis. With extensive experience and expertise, they can support all phases of oligonucleotide development. Equipped with state-of-the-art instruments and co-located with the API process development team, our oligonucleotide analytical services streamline your oligonucleotide development with customized, flexible, and integrated analytical solutions.
Our Services
- method development and validation
- stability study: forced degradation study, accelerated and long-term stability studies under R&D and GMP conditions
- purity and assay: residual solvents, moisture, sodium content, anion residual, oligonucleotide content, elemental impurities
- microbiological safety: endotoxin for limit and quantitation, bioburden for microbial limit test, microbe ID and strain typing
- oligonucleotide backbone composition by 31P NMR
- process related impurity identification: 2D UPLC coupled with Q-TOF HRMS
- identity by molecular weight and sequencing: UPLC Q-TOF and MALDI-TOF/TOF HRMS for accurate MW and sequence determination
Chromatographic Techniques
- High Performance Liquid Chromatography (HPLC)
- High Performance Liquid Chromatography coupled with Mass Spectrometry (HPLC-MS)
- Ultra-High Performance Liquid Chromatography (UHPLC - available detectors: UV, CAD)
- Ultra-High Performance Liquid Chromatography coupled with Mass Spectrometry (UHPLC-MS)
- 2D Ultra-High Performance Liquide Chromatography (2D-UPLC)
- Gas Chromatography (GC)
- Ion Chromatography (IC)
Mass Spectrometry Techniques
- Electrospray Mass Spectrometry (ESI-MS Orbitrap & Q-TOF)
- Matrix Assisted Laser Desorption/Ionization Mass Spectrometry (MALDI-TOF/TOF)
- Tandem Mass Spectrometry Sequencing (Q-TOF, Orbitrap & MALDI-MS/MS)
- 2D Ultra-High Performance Liquide Chromatography coupled with HRMS (Q-TOF)
- Mass Spectrometry purity and impurity quantitation (Q-TOF, single quadrupole)
- Gas Chromatography Coupled with Mass Spectrometer (GC-MS)
Spectroscopic Techniques
- Infrared Spectroscopy (IR)
- UV/VIS Spectroscopy
- Tm (UV melting curve)
- Circular Dichroism Spectroscopy (CD)
- Nuclear Magnetic Resonance Spectroscopy (1H, 13C, 31P & 19F - NMR)
Other Techniques
- elemental analysis (CHN)
- polarimetry
- osmolality
- titration
- TGA
- XRPD
- Total Organic Carbon (TOC)
- total viable aerobic counts
- endotoxins (LAL-test)
- heavy metals
- hygroscopicity (DVS)
- molar extinction coefficient determination