Our Services
From in-stock catalog standards to complex custom synthesis — full analytical characterization included with every product.
Catalog Pharmaceutical Impurities
A growing library of pharmaceutical impurity reference standards across major drug classes — ready to ship with complete analytical documentation.
Each catalog compound is fully characterized in-house. When you order from our catalog, you receive more than a chemical — you receive a validated reference standard designed for regulatory use.
Included with Every Catalog Order
Custom Pharmaceutical Impurity Synthesis
Can't find the compound you need in our catalog? Our experienced synthetic chemistry team synthesizes pharmaceutical impurities to your exact specifications.
What We Can Synthesize
Our Custom Synthesis Process
Submit Request
Provide the compound structure, CAS number, or description of what you need.
Feasibility Review
Our chemistry team evaluates the synthesis route and provides a timeline + quote within 48 hours.
Synthesis Begins
Upon agreement, we initiate synthesis using established or novel routes.
Full Characterization
Every custom compound undergoes the same rigorous analytical validation as our catalog products.
Delivery
Product ships with complete analytical data package and CoA.
Comprehensive Analytical Data Packages
Every product we supply ships with a complete analytical data package designed to meet FDA, EMA, and ICH regulatory requirements.
Certificate of Analysis
Batch-specific CoA with purity, storage conditions, expiry date, and method references.
HPLC Chromatogram
UV-detected HPLC purity report with retention time and peak area data.
NMR Spectra
1H-NMR and 13C-NMR spectra in appropriate deuterated solvent for structural confirmation.
Mass Spectrometry
High-resolution MS (HRMS) or standard MS for molecular ion and fragmentation confirmation.
ICH-Compliant Regulatory Support Impurities
Our impurities are synthesized to support regulatory submissions under internationally recognized guidelines.
Impurities in New Drug Substances — threshold-based impurity profiling for APIs.
Impurities in New Drug Products — degradation products in finished dosage forms.
Residual Solvents — classification and limits for ICH Q3C solvent impurities.
Start Your Project Today
Request a catalog quote or discuss a custom synthesis requirement with our team.