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Characterization

From impurity identification to primary reference standards, our analytical chemists can assist with both routine and challenging characterization projects. Cyanta provides characterization services for drug substances, excipients, drug products, degradant impurities, process impurities and the evaluation of container closure systems.

Our GMP facilities contain the following the isolation and characterization capabilities:

  • Liquid/liquid and solid phase extraction
  • Preparatory TLC
  • Flash chromatography
  • Semi-preparatory liquid chromatography
  • Recrystallization
  • Solid Phase Extraction (SPE)
  • Semi-preparatory HPLC
  • Radial chromatography
  • NMR (31P, 19F, 15N, 1H and 13C)
  • FTIR and HATR-IR
  • MS and MS/MSn
  • Assay (UV, HPLC, GC, CE and IC)
  • Chromatographic purity (TLC, CE, HPLC and GLC)
  • Metallurgical catalysts (ICP-MS, AA, AE)
  • Moisture (KF, CKF)
  • Thermal Studies (DSC and TGA)
  • Inorganic ash (ROI, ICP, ICP-MS, AA)
  • Reference Standard Qualification

Case Study: Impurity Identification and Characterization

A client approached Cyanta with an unknown impurity which was forming in their drug product and requested its identification, isolation and characterization. The drug product contained 100 micrograms of API which included 2 micrograms of an unknown.

Cyanta transferred in the client's HPLC method and were able to confirm the presence of the impurity and then performed a preliminary identification of the unknown peak by LC/MS/MS. In order to obtain a greater amount of the impurity Cyanta placed the drug product under stressed conditions. They demonstrated the presence of the impurity increased greatly under accelerated stability conditions.

Using "semi-prep" techniques, the impurity was isolated from samples subjected to the accelerated conditions and accurately identified by HPLC and LC/MS/MS. It was found that the impurity was the result of interactions between the active ingredient and one of the key excipients. Cyanta further supported the client by synthesizing reference material and performing extended stability studies on the drug product.