Recently, Guangzhou HC Pharmaceutical successfully helped a global top ten overseas pharmaceutical company solve the difficult problem of trace impurities, and received praise from customers.
In recent years, Guangzhou HC Pharmaceutical has successfully cooperated with many well-known pharmaceutical companies at home and abroad, helping to solve the difficult problem of impurity research, providing solutions for impurity research applied for and supplemented by many domestic pharmaceutical companies, and successfully helping enterprises obtain approvals and enter centralized procurement.
Guangzhou HC Pharmaceutical will continue to maintain a spirit of research and dedication to the future through technology, assisting more enterprises in high-quality, efficient, and high-speed development.
Business introduction
Guangzhou HC Pharmaceutical has established a high difficulty impurity solution platform in the field of drug impurity research, committed to providing customers with a one-stop solution to meet their needs for impurity research and quality standard establishment throughout the entire drug lifecycle, including drug research and development, registration, production, quality standard improvement, and product re registration. We focus on providing high-quality impurity research services for the separation and structural identification of high difficulty and trace impurities, I have extensive experience in the separation of unstable impurities.
The impurity research platform complies with the requirements of the quality control laboratory system, ensuring that the experimental process records of impurity synthesis, preparation, purification, structural identification, detection, calibration, etc. are complete and traceable, and meet the requirements of global drug registration and declaration.
Business scope
High quality impurity reference substance
Separation and purification of trace impurities
Structural confirmation of unknown impurities
Customization of high difficulty impurity reference standards
Writing of supplementary materials and response opinions for the publication of impurity research
Compilation of supplementary information and response opinions for the publication of impurity research
Separation of impurities without UV absorption
Separation and purification of unstable impurities
Project experience
In recent years, hundreds of impurity research projects have been completed, with significant advantages in the field of antibiotics. Including all cephalosporins, penicillin, some macrolides, aminoglycosides, etc.
