Impurities Isolation and Structure Identification

Our strength in analytical services is in the structure elucidation of unknown impurities and organic compounds. We specialize in the analysis of and peak assignment of given organic compounds. Along with NMR studies and full analysis of an unknown impurities, we can establish the structure of the unknown compounds.

Case Studies:

An MNC approached R&S Chemicals for structure identification of an unknown impurities in a marketed drug with highly complex structure. At R&S Chemicals, we thoroughly analyzed the unknown impurity through various analytical techniques:

We performed NMR studies such as 1H, 13C, 13CDEPT135, COSY, NESY, HMBC & HSQC folloed by FT-IR; LC-MS/MS, UV-Vis.

With all the information in hand, we were able to identify and generate a technical report to submit to the FDA by client after TOX studies. After reviewing, the FDA accepted our proposed structure of the impurities, and our client was able to re-market the drug.

We have performed nine similar full-length studies for structure elucidation of unknown impurities for this client.