Alpha Laboratories uses advanced and sensitive tools to ensure your pharmaceutical and cosmetic products are compliant with U.S. FDA, EMA, and Health Canada requirements.
Mutagenic impurities in Active Pharmaceutical Ingredients (APIs) and drug products pose a significant risk to health and safety.
Traces of N-nitrosodimethylamine (NDMA) and N-Nitrosodiethylamine (NDEA) found in some Active Pharmaceutical Ingredients (APIs) caused several market recalls. Detection of these impurities in APIs and some finished products raised additional concerns about patient safety
Detection and quantification of these trace nitrosamines in APIs and drug products can be challenging, necessitating the use of advanced and sensitive tools to meet regulatory requirements.
Mutagenic impurities can damage DNA, leading to mutations and potentially cancer.
Health Canada, U.S. FDA and the European Medical Agency (EMA) have published guidelines and limits for nitrosamine contaminants.
Alpha Labs developed highly selective and sensitive methods for the quantitation of nitrosamines impurities in pharmaceutical and cosmetic products by QSight® Triple Quadrupole LC/MS/MS.
Alpha Labs analyses nitrosamine impurities using Liquid Chromatography with Triple Quadrupole mass spectrometry (LC/MS/MS) in your pharmaceutical & cosmetic products, helping you to ensure product safety and compliance with U.S. FDA, EMA and Health Canada requirements.
