Chiral Molecules

Enantiomerically Characterized Chiral Reference Standards for Stereochemical Analysis and Regulatory Compliance

Clinivex supplies chiral reference standards with defined enantiomeric excess (ee) and absolute configuration assignment, providing the authenticated reference materials essential for chiral HPLC and SFC method development, polarimetric purity assessment, and stereospecific impurity quantification in drug substance and drug product quality control environments. Each standard undergoes rigorous characterization by chiral HPLC, optical rotation measurement, NMR spectroscopy, and where applicable, X-ray crystallography — ensuring unambiguous stereochemical identity and enantiomeric purity documentation aligned with ICH Q6A, FDA stereochemical guidance, and EP 2.2.46 requirements. Our catalog supports racemization studies, chiral switching programs, and enantioselective pharmacokinetic investigations across small molecule therapeutics, agrochemicals, and fragrance chemistry. For chiral amino acid derivatives and non-proteinogenic amino acid standards specifically, our amino acid reference standards catalog provides enantiomerically characterized materials covering both proteinogenic and non-standard forms.

Clinivex delivers every chiral reference standard with a Certificate of Analysis (CoA) documenting enantiomeric purity, optical rotation value, chiral analytical method details, and storage conditions fully traceable to ISO 17025-accredited characterization protocols. Sourced from GMP-experienced chiral synthesis specialists, our standards provide the stereochemical certainty your method validation packages and regulatory dossiers demand. For active pharmaceutical ingredient characterization programs requiring both chiral purity and drug substance potency data, our complementary API reference standards portfolio provides the primary reference materials needed for compendial and non-compendial drug substance testing. Speak with our technical team to identify the right enantiomer or racemate for your specific analytical program.