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Audit-Ready Oligo QC with Full ISO Compliance.

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Oligonucleotide Release QC Testing Services

Fast, compliant release testing for DNA/RNA oligonucleotides—covering identity, purity, impurities, safety testing, and complete CoA for GMP and non‑GMP lots.

ISO 9001: 2105 ISO 13485: 2016 ICH Q2 (R2) Methods USP/EP Aligned
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Overview

Our Oligonucleotide Release QC program provides fast, compliant testing for DNA/RNA oligos with audit‑ready documentation. Panels cover identity, purity/impurities, safety testing, and general attributes so lots can be released with confidence for RUO, GLP, or GMP use.

Choose a standard non‑GMP QC panel for speed, a full GMP release panel with QA oversight, or a custom package with client method transfer and ICH Q2(R2) validation.

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At-a-Glance

  • Identity: LC–MS (ESI) or MALDI; optional digest mapping
  • Purity / Impurities: RP‑/IP‑RP‑HPLC, CE; IEX for charge variants
  • Residuals: GC (solvents), ICP‑MS (metals)
  • Sodium content: Ion chromatography or flame photometry
  • General: Karl Fischer water, pH, appearance; endotoxin/bioburden
  • Turnaround: 3–7 business days (non‑GMP), 7–15 days (GMP)
Standard
Non‑GMP QC Panel
  • Identity: LC–MS or MALDI–TOF
  • Purity: RP‑HPLC or IP‑RP‑HPLC
  • UV/OD260 quantitation
  • Salt/TEAA check (conductivity)
  • Optional: CE purity, IEX charge variants
GMP
GMP Release Panel
  • Identity: LC–MS (intact) ± enzymatic digest mapping
  • Purity: validated RP/IP‑RP‑HPLC with impurity reporting
  • Residual solvents (GC), Elemental impurities (ICP‑MS)
  • Karl Fischer water; pH & appearance
  • Endotoxin (LAL), Bioburden (USP), DNase/RNase (as needed)
Custom
Method Transfer & Validation
  • Client method transfer + verification
  • ICH Q2(R2): accuracy, precision, linearity, range, robustness
  • Custom impurity targets (n‑1/2, depurination, shortmers)
  • Sequence‑specific assays (LC‑MS/MS, enzymatic digestion)
  • Stability‑indicating methods (heat, pH, enzymatic stress)

Methods & Instrumentation

Category Primary Methods Purpose
Identity LC–MS (ESI), MALDI–TOF; enzymatic digest mapping Confirm mass; verify sequence by fragment mapping when required.
Purity RP/IP‑RP‑HPLC, CE; IEX for charge variants Quantify full‑length vs. shortmers, n‑1/n‑2, process impurities.
Impurities GC (residual solvents), ICP‑MS (elemental), UV/OD260, conductivity Assess ACN/TEAA/others; metals; carryover salts/buffers.
Safety LAL endotoxin, USP bioburden, sterility (if applicable) Demonstrate microbial control for aseptic applications.
General Karl Fischer, pH, appearance, osmolality (as needed) Support release specifications and formulation requirements.

Techniques vary by sequence length, chemistry (PS, PN, boranophosphate, methylphosphonate), and mods (2′‑OMe, 2′‑F, LNA/BNA, cEt, dyes, lipids, GalNAc, PEG).

Release Criteria (Examples)

Attribute Typical Spec Method
Identity Intact mass within ±5 ppm ESI LC–MS
Purity ≥ 85–98% main peak RP/IP‑RP‑HPLC
Residual Solvents Meets ICH Q3C GC
Elemental Impurities Meets ICH Q3D ICP‑MS
Sodium Content Report / meets target range Ion Chromatography or Flame Photometry
Endotoxin ≤ 0.5 EU/mg (use‑case dependent) LAL
Bioburden USP <61>/<62> acceptance Culture/USP
Water Content Report or target range Karl Fischer
DNase/RNase Not detected (if applicable) Activity assays

Final specs set per program needs and regulatory strategy.

How Release QC Works

  • Scope & Quote: Share target specs, modality, and use‑case (research, diagnostic, GMP). We return a detailed panel and quote.
  • Sample Receipt: Chain‑of‑custody, storage, and lot metadata verified on intake.
  • Testing & Review: Trained analysts execute methods; second‑person review and QA oversight for GMP panels.
  • Report & CoA: Methods, chromatograms/spectra, calculations, and pass/fail vs. specs.

Sample Requirements & Shipping

  • Amount: Typically ≥ 200 μg (method‑dependent). Provide extra aliquot for ICP‑MS/GC if possible.
  • Format: Dry or in buffer; include length, chemistry, purification, concentration, storage conditions.
  • Shipping: Ambient for DNA; cold chain suggested for RNA/ASOs. Insulated packaging; SDS if applicable.

What Sets Us Apart

  • Flexibility — scalable from quick feasibility to full GMP release and stability.
  • Breadth — supports PS, PN, boranophosphate, methylphosphonate; 2′‑OMe, 2′‑F, LNA/BNA, cEt; custom conjugations (dyes, lipids, GalNAc, PEG).
  • Purification Excellence — HPLC/CE/IEX and diafiltration workflows produce clean materials and clean data.
  • Regulatory Alignment — ISO 9001/13485 QMS, GLP practices, QA‑oversighted GMP panels and audit support.
  • Customization — OEM/private‑label supply, formulation support, and long‑term agreements.
Programs
Stability Studies

ICH Q1A(R2) accelerated/intermediate/long‑term with stability‑indicating methods and summary reports.

Request a Study Plan
Methods
Analytical Method Development & Validation

Scouting → optimization → transfer → ICH Q2(R2) validation with protocols, raw data, and reports.

Discuss Your Method
Manufacturing
Custom Oligonucleotide Synthesis

RUO to GMP‑aligned oligos; HPLC/PAGE, diafiltration; broad chemistry & conjugation support.

Explore Synthesis

Start Your Release QC

Tell us about your oligo and required release specs. A scientist will respond with a tailored panel and timeline.


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FAQ

What is included in oligonucleotide release QC?
Identity (mass and, if needed, fragment mapping), purity with impurity profiling, safety testing (endotoxin/bioburden), general attributes (water, pH, appearance), and a signed CoA against predefined specifications.
How are specs defined?
We start from typical ranges for modality and use‑case, then finalize with you to reflect risk, formulation, and regulatory strategy.
Do you offer GMP testing?
Yes. GMP panels include QA oversight, instrument/equipment traceability, and data package suitable for audits.
What sample amount do I need?
Most panels can be run with ≥ 200 μg. Complex impurity/elemental panels may require more—ask us for study‑specific guidance.
How fast is turnaround?
Non‑GMP panels typically 3–7 business days; GMP panels 7–15 days depending on scope and queue.
Can you transfer my in‑house method?
Yes. We routinely execute method transfer and verification and can perform full ICH Q2(R2) validation where needed.

Contact

Email: info@biosyn.com • Phone: +1 (972) 420‑8505

Why Choose BioSynthesis

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