Docuchem offers a service of Nitrosamines analysis in pharmaceutical products by Liquid chromatography coupled to MS/MS.
On Docuchem laboratories, different methods to determine Nitrosamines at ppb concentration level in different pharmaceutical products have been developed successfully using a mass spectrometer triple quadrupole 8050 from Shimadzu.
The LC-MS/MS technique using an APCI ionization source allows us to achieve the maximum possible sensitivity, reaching levels of detection (LOD) of 0.1 ppb and limits of quantification (LOQ) of 0.2 ppb.
This technique has proved to very specific, precise and accurate for the analysis of Nitrosamines at ppb levels in different types of matrix compared with other available techniques.
The analysis performed in our laboratories are under GMP compliance and our qualified staff have large experience in Nitrosamines analysis. We have certified reference standards of 15 different Nitrosamines and the methods developed in our labs have proved to be specific for all of them.
In May 2017 Docuchem received the EU-GMP compliance certificate (Good Manufacturing Practice) for Quality Control of Drug Products after the audit conducted by the Spanish Drug Authorities.
The laboratory holds an authorization for the physicochemical Control of Drug Products for human, veterinary and investigational use.
Docuchem has proven to have compliant facilities, procedures and complete documentation for each aspect of the process of development, analysis, production and logistics related to the Control of Drug Products.