Identification & quantification
The nitrosamine challenge
nitrosamines we have methods for nitrite determination in API/excipients and drug products with LOQ 10-50ppb.
Our network of laboratories develop analytical solutions to identify and quantify all nitrosamine contaminants, including the challenging nitrosamine drug substance related impurities (NDSRIs). This class of contaminants, specific to each drug substance, demands dedicated expertise, to fully characterize contaminants with a view to developing an analytical solution to monitor them.
COLLABORATE IN TESTING PROGRAMS
Why use SGS? SGS has developed a network of center of excellence laboratories across all regions to better serve our clients. Our experts specialise in method development using mass spectrometry equipment, for complete accuracy and reliability. Using our preferred audited partners, we provide sample shipment management from clients' manufacturing sites to SGS laboratories all over the world. SAMPLE LOGISTICS We offer a variety of partnership models and collaborate in testing programs using fee-for- service to outsource staffing models.
OPTIMIZING EXTRACTION PROCEDURES Our solutions
Our experience enables us to reach the relevant limit of quantitation in drug products, drug substances and raw materials (based on the acceptable daily intakes defined by the USFDA and EMA). As a result, a method for any relevant nitrosamine (from generic small nitrosamines such as NDMA, NDEA, etc. to NDSRI’s) can be developed specifically for a product. In addition, to help assess materials or the formation of
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