Pharmaceutical Standards Divisions
Organized by analytical regulatory compliance scopes to streamline your method validation, impurity profiling, and genotoxic risk assessments.
Nitrosamine Impurities & NDSRIs
High-purity small molecule nitrosamines (NDMA, NDEA, NMBA) and complex Nitrosamine Drug Substance-Related Impurities (NDSRIs) synthesized for ultra-trace LC-MS/MS and GC-MS/MS quantification below Toxicological Concern (TTC) thresholds.
- • N-Nitrosodiethylamine (NDEA) — CAS: 55-18-5
- • N-Nitrosodimethylamine (NDMA) — CAS: 62-75-9
- • N-Nitroso-N-methyl-4-aminobutyric acid PEA
Pharmacopeial Reference Standards
Characterized working standards meeting and exceeding monograph specifications for United States Pharmacopeia (USP), European Pharmacopoeia (Ph. Eur.), British Pharmacopoeia (BP), and Indian Pharmacopoeia (IP).
- • Apixaban Impurity 3 — CAS: 503615-07-4
- • Clopidogrel Related Compound B — CAS: 144750-52-7
- • Valsartan Related Compound A — CAS: 955365-80-7
Chiral & Isomer Standards
Enantiomeric reference materials, diastereomers, conformers, and cis/trans geometric isomer standards synthesized through stereospecific pathways and characterized with chiral HPLC and polarimetry.
- • Suvorexant (S)-Isomer — CAS: 1075249-38-9
- • Lurasidone Impurity 1 — CAS: 367352-16-7
- • Sitagliptin Chiral Related Markers
Drug Metabolites & Glucuronides
Phase I oxidative metabolites (hydroxylated, N-oxide, dealkylated derivatives) and Phase II acyl and ether glucuronide conjugates for DMPK, bioequivalence, and toxicology testing.
- • Regioselective Glucuronide Conjugation
- • Deuterated & 13C Stable Isotope Markers
- • N-Demethylated & Sulfate Conjugates