Synthesis of 14C Radiolabeled API to GMP

The synthesis of 14C-radiolabeled active pharmaceutical ingredients (APIs) plays a critical role in drug development and regulatory approval. By enabling precise tracking of drug metabolism, absorption, distribution, and excretion, 14C-labeled APIs facilitate detailed pharmacokinetic and toxicological studies. However, these studies require 14C-labeled APIs synthesized under stringent regulatory guidelines to ensure safety, efficacy, and compliance with Good Manufacturing Practice (GMP) standards. Alfa Chemistry specializes in synthesizing and providing high-quality 14C-radiolabeled APIs tailored to meet the specific requirements of drug development studies. All processes are conducted in accordance with EMEA regulations and the recent FDA Phase I GMP guidance (ICH Q7A Section 19: Single batches for investigational drugs).

Our Services

We offer specialized services for the synthesis and release of 14C-radiolabeled APIs for Phase I, mass balance, and microdosing studies (Phase 0 and enhanced Phase I). Our suite of services includes:

Our Facilities

Our infrastructure is designed to handle 14C-radiolabeled APIs synthesis projects efficiently and safely.

Dedicated GMP Synthesis Laboratories

We operate multiple independent GMP laboratories, each equipped with advanced fume hoods and dedicated setups. This allows us to conduct multiple radiolabeled synthesis projects simultaneously without risk of cross-contamination.

Independent GMP QC Laboratory

A separate GMP-compliant Quality Control (QC) laboratory ensures that every synthesized API undergoes rigorous testing and meets the highest quality and purity standards. The laboratory is equipped with state-of-the-art analytical technologies, including but not limited to:

Moreover, our QC laboratory provides complete batch records, CoAs, and QC reports, ensuring full traceability and compliance with GMP.

Why Partner with Us?

The synthesis of 14C-radiolabeled APIs to GMP standards is an essential step in modern drug development. By combining advanced facilities, stringent quality control, and extensive expertise, we ensure the successful delivery of high-quality 14C-radiolabeled APIs for your research and clinical needs. For additional details about our services or to discuss your requirements, please reach out to us directly.

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Synthesis of 14C Radiolabeled API to GMP

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