Radiolabeling and Quality Control Services

Service overview

Our radiolabeling and quality control service delivers purified, characterized radiolabeled compounds for preclinical pharmacokinetic, biodistribution, and efficacy studies. We work with a broad range of isotopes — including Lu-177, I-125, C-14, tritium, and Zr-89 — and offer both research-grade and quality-controlled options. Each project begins with isotope selection and conjugation strategy, followed by reaction optimization (chemical or enzymatic), purification via HPLC or solid-phase extraction, and a comprehensive quality control panel.

Quality control includes radio-TLC, radio-HPLC, mass confirmation, specific activity measurement, and radiochemical purity determination (target ≥ performance scoped per project). Stability studies under relevant storage and biological conditions are conducted and documented. The final deliverable is a ready-to-use radiolabeled product accompanied by a detailed certificate of analysis, supporting your downstream preclinical or early-phase clinical investigations.

What we offer

Custom Radiolabeling

Targeted conjugation and radiolabeling of small molecules, peptides, antibodies, and proteins with your isotope of choice. We optimize reaction conditions to achieve high specific activity and radiochemical yield.

Quality Control Development & Validation

Development and validation of QC methods (radio-HPLC, radio-TLC, mass spectrometry) to ensure batch-to-batch consistency. Analytical protocols are tailored to the compound and intended use.

Regulatory & Documentation Support

Comprehensive documentation including certificate of analysis, stability reports, and analytical data packages. For GMP projects, we support IMPD sections and regulatory submission readiness.

Workflow

Project Consultation & Isotope Selection We review your target molecule, intended application, and preferred isotope. A feasibility assessment and conjugation strategy (e.g., chelator attachment, direct labeling) are developed collaboratively.

Radiolabeling Reaction & Purification Radiolabeling is performed under controlled conditions (thermal, pH, buffer, time). The crude product is purified by HPLC or SPE to remove unbound isotope and side products, yielding a pure radiolabeled compound.

Quality Control Analysis Radiochemical purity is verified by radio-HPLC and radio-TLC. Identity is confirmed by co-elution with reference standard or mass spectrometry. Specific activity and total activity are measured and reported.

Stability Testing & Final Formulation Short-term and long-term stability is assessed under storage and simulated physiological conditions. The product is formulated (buffer exchange, excipient addition if needed) and packaged for shipment with documentation.

Deliverables

Deliverable	Description
Purified Radiolabeled Compound	Scoped per project after consultation
Certificate of Analysis (CoA)	Documents radiochemical purity, specific activity, identity confirmation, and QC test results. Includes method references and acceptance criteria.
Stability Study Report	Data on radiochemical stability over time under defined storage conditions and in relevant biological matrices (e.g., serum).
QC Method Development Summary	Description of analytical methods developed or adapted for your compound, including validation parameters (linearity, precision, accuracy).
Analytical Data Package	Full set of radio-HPLC/radio-TLC chromatograms, mass spectra, and specific activity calculations for each batch.

Why choose us

End-to-End Service Integration

From isotope procurement and radiolabeling through QC, stability, and documentation, we manage the entire workflow. This reduces handoffs and accelerates your project timeline.

GMP-Ready Operations

Our radiolabeling and QC processes can be scaled to GMP standards for investigational medicinal product (IMP) manufacturing, including QP release and regulatory dossier support.

Experienced Radiochemistry Team

Our scientists have deep expertise in handling a wide range of isotopes and conjugation chemistries, ensuring robust labeling strategies for diverse molecular formats.

Flexible Engagement Models

We tailor the scope to your stage — whether you need a one-off labeling batch, full method development with validation, or integrated CMC support for IND/CTA submission.

Ready to start your project?

Our team is ready to discuss your radiolabeling needs, from isotope selection and method development to full GMP production. Contact us to review your target molecule and receive a tailored project proposal.