Analysis of nitrosamines and impurities in medicines
Análisis de nitrosaminas en medicamentos para detectar y cuantificar estas impurezas y garantizar la seguridad del paciente
At MCI, we understand the critical importance of nitrosamine analysis in pharmaceuticals to detect and quantify these impurities in drug products, thereby ensuring patient safety and compliance with international regulations.
Nitrosamines are potentially carcinogenic compounds that can form during the manufacturing of medicines, and their presence, even at minimal levels, can pose a significant risk to health.
Service offered in collaboration with and developed by Netpharmalab and Docuchem (Spain)
Nitrosamine analysis using advanced methodologies
Our nitrosamine impurity analysis service uses advanced analytical techniques to identify and quantify these compounds in pharmaceutical products.
We use methods such as gas chromatography coupled with mass spectrometry (GC-MS/MS) and high-performance liquid chromatography (HPLC) to detect nitrosamines at extremely low concentrations, thereby ensuring precise and reliable assessment.
The nitrosamine analysis process begins with proper sample preparation and treatment to maintain the integrity and reproducibility of results. Our experts develop and validate specific methods for each type of pharmaceutical product, taking into account the unique characteristics of the formulation and manufacturing process.
Method validation includes evaluating critical parameters such as sensitivity, specificity, linearity, precision, and accuracy, ensuring that our analyses comply with regulatory standards set by authorities such as the FDA, EMA, and ICH.
Stability studies for nitrosamine control
At MCI, we also stay up to date with the latest guidelines and recommendations issued by international health authorities, adapting our methods and procedures as needed to meet the most recent requirements.
This includes the ability to conduct stability studies to monitor the formation of nitrosamines over time and under various storage conditions.
Quality, safety, and scientific rigor
Our commitment to quality and safety is reflected in the accuracy and reliability of our nitrosamine analyses.
By choosing MCI as their analytical partner, pharmaceutical companies can be confident that their products will be evaluated with the highest level of scientific rigor, helping them comply with regulatory requirements and safeguard patient health.
