LC-MS-MS
Thermo Scientific™ TSQ Quantis™ Triple Quadrupole Mass Spectrometer instrument is with Chromeleon software, best-in-class with 21 CFR
Thermo Scientific™ TSQ Quantis™ Triple Quadrupole Mass Spectrometer instrument is with lowest sensitivity achievable for quantification of nitrosamines impurities and as well as extractable and leachable compounds quantification.
ICP-MS
Thermo Scientific iCAP RQ ICP-MS is specially for a complete trace multi-element analysis with comprehensive interference removal for assured data accuracy.
With lowest sensitivity for quantification for heavy metals along with ICH Q3D list elements User friendly Qtegra™ Intelligent Scientific Data Solution™ (ISDS) software allows user for easy interpretation.
GC-MS-MS
Thermo Scientific™ TSQ™ 8000 Evo Triple Quadrupole GC-MS/MS and FID detector with Chromeleon software
Headspace Autosampler allows quantification and identification of volatile compounds while FID detector is useful for routine analysis and validation for residual solvents
Triple Quadrupole MS detector applicable for quantification of nitrosamines impurities with FDA published method as well as inhouse methods with lowest sensitivity.
Inbuild NIST library will be helpful for identification of majority compounds observed during extractables and leachable study.
SEM
Scanning electron Microscope with Energy Dispersive X-Ray Spectroscopy (SEM-EDS), used for surface analysis and material characterisation. Generally, for glass delamination as per USP 1660.
Scanning electron microscopy (SEM) is a method for high-resolution imaging of surfaces. The SEM uses electrons for imaging, much as a light microscope uses visible light. The advantages of SEM over light microscopy include much higher magnification (>100,000X)
The EDS technique detects x-rays emitted from the sample during bombardment by an electron beam to characterize the elemental composition of the analysed volume.