NDMA and NDEA are the simplest dialkylnitrosamines. These compounds are classified as a Group 2A carcinogen (probable human carcinogen) by the World Health Organization.
Recently, some drug products were discovered to have been contaminated with NDMA and NDEA. It is believed that they were introduced into the finished products during the manufacturing process.
It is therefore essential to have a sensitive, accurate, reliable and robust analytical method available based on a suitable technique. A headspace Gas chromatography Mass Spectrometry method has been developed to detect the presence of NDMA in drug substances.
In this experiment, headspace-Autosampler HS-20 instrument will be used. To suit for this headspace instrument, 20mm crimp headspace vial should be chosen. In aijiren product catalog, there are 6ml, 10ml, 20ml vials, whose size of mouth is 20mm crimp vial.
A mixture of NDMA and NDEA was used to prepare calibration curves ranging from 2.5-10 ug/L. According to reagent volume, the 10ml headspace crimp vial is the suit one.
Aijiren is one of the largest chromatography consumable manufacturer in south of China. Its headspace crimp vial has many models. But all the headspace crimp vial are wholesale price. Please inquiry us for free sample about crimp headspace vial.
In your Extending GCMS experiment about active pharmaceutical Ingredients, headspace vial is a important role.