Quality Control Tests
BiOligo provides 100+ quality control methods covering structural characterization, purity analysis, water content, endotoxin testing, osmolality, free acid content, sodium ion quantification, viscosity analysis, and more. Customized QC solutions can be tailored based on modification types, modification stereochemistry, and development stage requirements.
| Test Item | Analytical Method | Quality Criteria | Standard QC | Customized QC | |
| ss-siRNA | Identification | LC-MS | Molecular weight within ±0.1% Da of theoretical value | ✔ | |
| Sequence confirmation | Sequencing analysis | Consistent with the intended sequence | ✔ | ||
| Purity | HPLC | ≥90%; impurities ≥1.0% reported | ✔ | ||
| Structural characterization | ³¹P NMR | Spectrum provided | ✔ | ||
| ds-siRNA | Appearance | Visual inspection | White to off-white powder | ✔ | |
| Identification | MS | Molecular weight deviation ≤0.05% from theoretical value | ✔ | ||
| Identification | Melting temperature (Tm) analysis | Tm value reported | ✔ | ||
| Duplex purity | HPLC | ≥90% | ✔ | ||
| Individual impurities | HPLC | Individual impurities ≥1.0% reported | ✔ | ||
| Content (% w/w) | Anhydrous free acid basis | Value reported | ✔ | ||
| Sodium ion content (% w/w) | Inductively Coupled Plasma Optical Emission Spectrometry (ICP-OES) | Value reported | ✔ | ||
| Water content | Coulometric Karl Fischer titration | Value reported | ✔ | ||
| Bacterial endotoxin | Kinetic chromogenic assay / kinetic turbidimetric assay | ≤0.25 EU/mg | ✔ | ||
| Viscosity | Microfluidic / capillary method | Value reported | ✔ | ||
| Osmolality | Freezing point depression method | Value reported | ✔ | ||
| Trace pH | Potentiometric method | Value reported | ✔ |
Reference Reports
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Bacterial Endotoxin Testing | Mass Spectrometry (MS) Analysis |
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Non-denaturing HPLC Analysis | Denaturing Duplex UPLC Analysis |
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Water Content Determination |
