Our work includes analysis and purification including chiral separation, high-throughput purification, physical and chemical properties determination, impurity separation and identification:

• Chiral and achiral separation;

• Extraction, separation and structure analysis of natural products;

• Separation and structure analysis of raw materials and drug impurities;

• High affinity selective mass spectrometry (ASMS) to screen small molecules;

• Determination of physical and chemical properties (pKa, LogP / LogD, solubility and concentration);

• Drug development analysis: including monitoring and quality control of APIs, intermediates, raw materials and finished products;

Method development and method validation

• API method development and verification (according to Chinese Pharmacopoeia, US Pharmacopoeia, European Pharmacopoeia, ICH, etc.)

• Residual solvent method development and verification (in accordance with Chinese Pharmacopoeia, US Pharmacopoeia, European Pharmacopoeia, ICH, etc.)

Routine analysis

• NMR 1D, 2D, etc. (including H-NMR, C-NMR, P-NMR, F-NMR, HSQC, HMBC, COSY, NOESY, etc.)

• LC-MS analysis

• HPLC analysis (including ELSD detection)

• Chiral purity test

• Pre-HPLC preparation and separation

• Routine physical and chemical tests (ROI, LOD, Cl-, SO42-, mp, HM, optical rotation, moisture determination, heavy metal residues, etc.)

Drug Impurity Analysis

• Use HPLC and other technologies to separate and supervise impurities in starting materials, intermediates, APIs and pharmaceutical products

• Collect complete 1D/2D NMR, LCMS, EA, HRMS, IR, UV and other data to identify the structure of the separated impurities

• Separation and structure identification of forced oxidative degradation products of API

• Use quantitative NMR (QNMR) to quickly determine the content of crude materials, intermediates, API and synthetic impurities

• Prepare application materials