Services
Our Services
Pharmaceutical Impurity Standards
Custom design, synthesis, and characterization of high-purity pharmaceutical impurity standards for analytical method development, validation, and regulatory compliance.
Reference Materials (RMs & CRMs)
Development and supply of certified and reference materials with complete characterization and traceability for quality control laboratories.
Nitrosamine Impurity Solutions
Specialized synthesis and supply of nitrosamine impurities to support regulatory testing, risk assessment, analytical validation, and pharmaceutical research.
Process-Related Impurities & Degradants
Synthesis of process impurities, intermediates, degradation products, and forced degradation compounds to support API and formulation development.
Unknown Impurity Isolation & Structural Elucidation
Isolation, purification, and structural identification of unknown impurities using advanced analytical techniques including LC-MS, HRMS, and NMR.
Stable Isotope-Labeled Compounds
Custom synthesis of deuterium, carbon-13, nitrogen-15, and other isotope-labeled compounds for bioanalytical studies and internal standards.
Custom Chemical Synthesis
Tailor-made synthesis of complex organic molecules, pharmaceutical intermediates, and specialty compounds according to customer specifications.
Analytical Method Development & Characterization
Comprehensive analytical support including purity assessment, structural confirmation, method development, validation, and stability studies.
Contract Research & Development (CRDMO)
End-to-end research and development process services from route scouting and process optimization to scale-up and research technology transfer.
Contract Manufacturing
GMP-compliant manufacturing of pharmaceutical reference standards, specialty chemicals, and custom molecules from laboratory to commercial scale.
Regulatory & Quality Support
Complete documentation including CoA, characterization reports, analytical data packages, and regulatory-compliant technical support.
Pharmacopeial & Non-Pharmacopeial Impurities
Extensive portfolio of USP, EP, BP, IP, JP, and custom non-pharmacopeial impurities for research and quality control applications.
Excipient-Related Impurities
Development and supply of impurities associated with pharmaceutical excipients related impurity for formulation studies and regulatory compliance.
Drug Metabolites & Glucuronides
Custom synthesis of human and animal drug metabolites for pharmacokinetic studies, bioanalysis, toxicology, and drug development programs.
