Custom Impurity Synthesis & Isolation

Drug impurity research is a core component of pharmaceutical development and quality control, directly impacting the safety, efficacy, and stability of drug products. Drug impurity synthesis and separation refer to the specialized synthesis and isolation of trace impurities that may arise during drug production, storage, or degradation.

Protheragen Impurity leverages robust scientific expertise, advanced technological platforms, an uncompromising commitment to quality, and a customer-centric service philosophy to provide you with comprehensive, customized impurity synthesis and separation services. Whether you need to synthesize a hard-to-obtain degradation impurity, complex process-related impurities, or isolate minor components from intricate mixtures, we have the confidence and capability to support you. Contact our expert team today to receive a personalized service and quotation. Let us collaborate to overcome the challenges of impurity research and safeguard your drug development.

Our Services

Protheragen Impurity offers a one-stop service, from molecule design to the delivery of final high-purity samples, to address complex impurity challenges.

Custom Synthesis of Impurity Standards

Our team of chemists possesses extensive expertise in organic synthesis, heterocyclic chemistry, chiral synthesis, fluorine chemistry, and peptide chemistry, enabling us to handle synthesis projects ranging from milligram to gram scale.

Complex Molecule Construction

We synthesize challenging molecular structures, including polycyclic systems, macrocycles, highly strained molecules, unstable compounds, and molecules bearing unique functional groups.

Chiral Impurity Synthesis

We synthesize single enantiomer or diastereomer impurities through multiple technical routes such as asymmetric synthesis, chiral resolution, and chiral chromatographic separation, meeting the stringent requirements of chiral drug research.

Genotoxic Impurities (GTIs) Synthesis

We synthesize structurally diverse potential genotoxic impurities (e.g., alkylating agents, aromatic amines, hydrazines, nitrosamines) to support method development, validation, and control strategy implementation.

Degradation Impurity Synthesis

We synthesize impurities generated from drug decomposition under various stress conditions (hydrolysis, oxidation, thermal, photolytic) to support drug stability studies.

Process Impurity Synthesis

Our expertise in organic synthesis enables us to replicate complex synthetic pathways for synthesizing impurities potentially generated or carried over during drug synthesis, including starting materials, intermediates, by-products, isomers, and catalyst residues.

Metabolite Synthesis

We synthesize major or key drug metabolites to support toxicological assessments and metabolic pathway studies.

Isotope-Labeled Impurities Synthesis

We synthesize stable isotope-labeled impurities (e.g., Deuterium (D), Carbon-13 (13C), Nitrogen-15 (15N)) for use as internal standards in highly sensitive LC-MS/MS quantitative analysis.

Impurity Isolation

We utilize preparative high-performance liquid chromatography (Prep-HPLC), supercritical fluid chromatography (SFC), conventional chromatography techniques, and other methods to isolate and prepare high-purity impurities from complex drug matrices.

Deliverables

Process of Our Services

Why Choose Us?