Our company is committed to providing rigorous impurity identification and analysis services to the pharmaceutical industry. We have state-of-the-art technology and equipment, and we can use HPLC, GC-MS, LC-MS, NMR, and LC-MS/MS techniques to accurately detect and quantify these impurities, regardless of their source. Please do not hesitate to contact us for any of your needs. If you have any needs, please contact us.
Our Services
The analysis of impurities plays a vital role in guaranteeing the safety and quality of API. Impurities can arise during the synthesis process, storage, or from various other factors, potentially posing health risks to patients. Hence, it is imperative to conduct thorough impurity analysis on APIs to ensure their safety and maintain high-quality standards.
At our company, our experts have many years of analytical experience in the field of structural elucidation and can provide you with the following services:
Impurity Screening
We utilize cutting-edge tools such as preparative HPLC, SFC, flash chromatography, and preparative TLC to separate and identify unknown impurities or trace impurities found in APIs.
Impurity Characterization
We can detect and analyze impurities found in APIs to help you in toxicology studies and guide the development of APIs. Our techniques include LC/MS, GC/MS, ICP-MS, HPLC, UPLC, FTIR, 400 MHz NMR (1H, 13C, 15N, 19F, and 31P), 2D NMR (COSY, HMBC, HSQC, and DEPT 135), high-resolution mass spectrometry (HRMS), etc.
The Workflow of API Impurity Analysis
The API impurity analysis typically includes the following aspects:
Our Advantages
- Advanced analytical technology: Our company adopts various advanced analytical technologies such as high-performance liquid chromatography, gas chromatography-mass spectrometry, liquid chromatography-mass spectrometry, and nuclear magnetic resonance, which can accurately and quickly analyze impurities.
- Diversified sample types: Our company can perform impurity analysis on various types of API samples, including chemically synthesized APIs, APIs extracted from natural medicines, etc.
- Rich experience: Our company has rich experience and expertise in the field of pharmaceutical analysis, and is able to provide professional impurity analysis services.
- High-quality service: Our company ensures high-quality impurity analysis services through strict quality control and reliable data analysis.
Delivery
The structure of impurities found in APIs
The amount of impurities found in the APIs
Other experimental data
Please kindly note that our services are for research use only.
