Characterization of impurities and degradants

The FDA regulates the presence of impurities in APIs, formulated drug products, food ingredients and cosmetics, and sets thresholds at which these impurities must be identified or adequately tested in safety and clinical studies. Investigation of these impurities must be initiated during the early stages of drug or product development, such as the pre-investigational new drug (pre-IND) stage.

We provide service to the characterization of impurities and degradants using modern mass spectrometry (MS) and nuclear magnetic resonance (NMR) techniques, including:

Impurity isolation from starting materials, intermediates, APIs, and drugs using prep. HPLC;

Structure identification using 1D/2D NMR, CMS, EA, HRMS, IR, UV, etc.;

Synthesis of impurities for comparison and confirmation of targeting impurities;

Isolation and structure elucidation of forced oxidative degradation products;

Quick determination of the quantitative content of impurities in crude materials, intermediates, API by Quantitative NMR (QNMR)

Preparation of application documents