AMPAC Analytical (AAL) is a global leader that supports all analytical requirements for pharmaceutical intermediates, Active Pharmaceutical Ingredients (APIs), and formulated drug products. From Analytical Method Development and Implementation to Analytical Method Validation and stability, AMPAC Analytical is fully equipped with fully compliant cGMP instrumentation geared toward product analysis and product release. AAL supports spectroscopy, chromatography, particle size distribution, calorimetry, osmolality, mass spectrometry, and ICH Stability project requirements.

Analysis Blog

In the entries below, we’ll share our thoughts and comments on these areas and other topics of interest. Please feel free to contact us to suggest topics of interest.


1/18/2022

Nitrosamines: An Overview
Nitrosamines are organic compounds found in the human diet and other environmental outlets. Being potent carcinogens that can cause tumors in nearly all organs, they have been classified as genotoxic impurities (GTIs). There are guidelines and rulings by various regulatory organizations, including the FDA, EPA, EMA, and the IARC (International Agency for Research on Cancer). Their presence and attendant concerns have been noted for many years. A.J. Gushgari and R.U. Halden wrote in Chemosphere, Nitrosamines were first proposed as “environmental carcinogens by William Lijinsky in 1970… (Read More)