Zhejiang Huahai Pharmaceutical Co., Ltd.

Zhejiang Huahai Zhicheng Pharmaceutical Co., Ltd

Wenbin Chen

Wenquan Zhu

Jinsheng Lin

Jing Wang

Min Li

Dan Li

Tong Wu

Tianpei Huang

Hong Cai

Yue Li

Qiang Zhou

Danfeng Ye

Tan Xiao

Xiaofei Liu

Provided are a pregabalin lactam methylene dimer and a preparation method therefor. The method comprises the following steps: dissolving pregabalin in a reaction solvent, reacting same with an aldehyde in an acidic system and isolating the obtained target product pregabalin lactam methylene dimer. The preparation method for pregabalin lactam methylene dimer provided by the present application has a simple operation, a high product yield, a good purity and a low cost.

Pregabalin lactam methylene dimer and preparation method therefor

Disclosed is a detection method for N-nitrosodimethylamine (NDMA) impurities, comprising: (1) obtaining a test solution containing a sample to be tested; and (2) detecting the test solution by means of gas chromatography-mass spectrometry to determine the content of an N-nitrosodimethylamine impurity in the sample. The method provided in the present invention has a good separating effect, a wide linear range, a high sensitivity and a good method durability, and can detect the content of N-nitrosodimethylamine (NDMA) in the sample rapidly and effectively.

Detection method for n-nitrosodimethylamine impurities

Growing community of inventors

Zhejiang, China

Wenbin Chen