Drug quality analysis platform

The platform has complete software and hardware resources, experienced research talents and advanced solid-state research and analysis instruments, such as HPLC, GC, LC-mass, Pre-HPLC and others, which can carry out quality research on APIs in the following aspects:

1.Standardized analysis and testing

According to the pharmacopoeia standards of various countries or the analysis methods independently developed, all kinds of items are tested, mainly including the following categories:

Physical constant

Melting point, density, pH value, optical rotation, conductivity, TOC, etc.


UV, IR, HPLC, etc.


Moisture, weight loss on drying, residue ignition, total ash, elemental impurities, residual solvents and related substances

Characteristic check

Appearance color, solution color, solution clarity, visible foreign matter, etc.


Content determination (including chromatography, volumetric method and gravimetric method)

Solid state analysis

Crystal form, particle size, packing density, bulk density and rheological fluidity

The main analytical instruments are as follows:

Chromatographic class

HPLC (VWD, DAD), flame ionizationdetector (FID)

Spectral class


Mass spectrometry

HPLC-mass, GC-mass, ICP-mass

Titration class

Potentiometric titrator, Karl Fischer water titrator

Physics and Chemistry

Melting point meter, pH meter, balance

Solid state class


2.Elemental impurity detection

Based on the requirements of ICH guidelines and pharmacopoeias of various countries, the analysis methods of elemental impurities in APIs were developed, confirmed and verified to provide the basis for risk assessment. The main instrument used was ICP-mass.

3.Detection of genotoxic impurities

In recent years, regulatory agencies in various countries, such as ICH, FDA, EMA, etc., have more clear requirements for genotoxic impurities. More and more pharmaceutical companies focus on the control and detection of genotoxic impurities in the process of new drug research and development. According to ICH M7 "Assessment and Control of DNA Reactive (Mutagenic) Immunities in Pharmaceuticals to Limit Potential Carcinogenic Risk", genotoxic impurities are studied. According to the different limits of genotoxic impurities, UPLC/UV and UPLC/QDa (single quadrupole rod) instruments can be used respectively.

4. Stability studies

Stability research is based on systematic research and understanding of APIs or preparations and their production processes, Through design experiments, the quality characteristics of raw materials or preparations change with time under the influence of various environmental factors (such as temperature, humidity, light irradiation, etc.), and provide supporting information for the determination of prescription, process, packaging, storage conditions and re-inspection period/validity period of drugs; Including influencing factor test, accelerated test and long-term sample retention test. The platform has MELT stability test chamber and other equipment.