AMSbiopharma introduces an important advance for the analysis of nitrosamines in different active pharmaceutical ingredients of vitamin B12

Nitrosamines represent a significant health risk, being potentially carcinogenic and a major concern in pharmaceutical manufacturing processes.

Drug discovery

AMSbiopharma, a company located in Lugo (Spain) and part of the AMSlab Group, which offers analytical solutions for the quality control of pharmaceutical products, announces the launch of an innovative service for the analysis of nitrosamines in vitamin B12.

This service, developed with state-of-the-art technology, makes a difference in the analytical services for the quality assurance in the pharmaceutical manufacturing of vitamin B12 drug substances.

Vitamin B12, an essential coenzyme for vital body functions, presents a unique chemical complexity, which makes that the vitamin 12 is a challenge for pharmaceutical analysis processes. In response to this need, AMSbiopharma has developed a unique UPLC-MS/MS analysis method capable of detecting and quantifying eight genotoxic nitrosamines.

The active ingredients of the Vitamin B12 include cyanocobalamin, hydroxycobalamin, methylcobalamin and cobamide.

Nitrosamines are a significant health risk due to their capacity to induce genetic mutation, being potentially carcinogenic and a major concern in pharmaceutical manufacturing processes. The presence of these impurities has led to the withdrawal of numerous medicines in recent years, emphasizing the vital importance of their detection and control.

In a process as delicate as drug development, every step is crucial to ensure the safety and efficacy of the final product. From initial development to scale-up production, each step must be subject to strict quality control procedures to detect and eliminate any potentially dangerous impurity. The presence of nitrosamines, as it was demonstrated in several recent cases, can compromise the safety of a medicine, which emphasizes the crucial importance of exhaustive analysis throughout all stages of the pharmaceutical development process. 

This is the reason why the exhaustive analysis of nitrosamines in vitamin B12 contributes to mitigate the risks associated with these impurities, reaffirming the company's commitment to the safety and efficacy of the quality control methods in the manufacturing of drug substances.

"We are delighted to introduce this new service which represents a significant progress to assure the safety of these drug substances," said Dr Jose Carlos Gonzalez, Director of AMSbiopharma laboratory. 

"The detection and quantification of genotoxic impurities in vitamin B12 is in line with AMSbiopharma's commitment to provide innovative solutions that meet the needs of the pharmaceutical industry".

AMSbiopharma has a long career in the pharmaceutical industry, being dedicated to providing analytical solutions to ensure the quality, safety and efficacy all through the development and manufacturing of drugs substances.