Structural Identification Of The Impurity Or By-product Produced In Drug Synthesis

In the modern pharmaceutical industry, drug development and manufacturing, the accurate identification of trace impurities and by-products is extremely important. Impurities and by-products may have potential toxicity to human being.There are stringent purity requirements for drugs and the important medical mediates in Pharmacopoeia of many countries. The general regulation for medicine is that the structural identification should be done when the content of impurity is more than 0.1%.Each marketed drugs must be safe, efficacious and quality controllable. The impurity analysis has always been the difficulty and emphasis in the international certification and the international registration.This experiment studied in the structural identification of the impurity or by-product which produced in drug synthesis. This studied used GC, HPLC, GC-MS, HPLC-MS , NMR , X-ray etc. The study is described as follows:1. The structural identification ofβ-DIMFO in 4-methoxy-furan and furan-2-one: The experiments show that the molecular formula ofβ-DIMFO is C11H12O6 . And we can give the correct structure ofβ-DIMFO by GC-MS, NMR and X-ray.2. Study on the by-product (MGMA) produced during the preparation of drug intermediate L-Menthol Glyoxylate: We get the structural of MGMA using the spectrum techniques.3. Structural identification of the impurity in 2-hydroxymethyl-acrylic acid methyl ester: Identified the structure of impurities directly from the mixture by HPLC-MS and the special NMR, especially the two-dimensional spectrum.