Within the scope of R&D Studies;
• Analytic Method Development - Verification / Validation Studies (ICH Q2 R, USP)
• Extractable, Leachable Analyses (LC-MS/MS, LC-HRMS, GC-MS, GC-MS/MS, ICP-MS, FTIR, IC Devices)
• Nitrosamine Impurity Analyses (Sartan Groups / Finished Product / Auxiliary Materials)
Our Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) infrastructure has been put into service by late 2020 for providing Phase 1 Clinical Research - Bioequivalence and Bioavailability Laboratory to the pharmaceutical industry.
YU-AGAM Pharmaceutical Analysis Laboratory provides service for the needs and demands of the sector by following nationally and internationally recognized analysis methods. For our laboratory; the application for authorization of Good Laboratory Practice (GLP) and preliminary inspection process filed with TÜRKAK have been completed as of 2020, and the authorization process is accomplished and the certification process continues.
We primarily provide analysis services in the following fields;
• Elemental Impurity and Metal (ICP-MS, ICP-OES),
• Quantitative (UV, UPLC, GC),
• Impurity (UV, UPLC, GC, GC-MS, GC-MS/MS, LC-MS),
• Residual Solvent (GC-FID, GC Headspace),
• Genotoxic Impurities (LC-HRMS-Orbitrap),
• Composition of Fatty acids (GC-FID),
• Ethylene Oxide and Dioxan (GC-FID),
• Hydroxypropoxy-hydroxymethoxy Group (GC-FID),
Morphological, crystallographic and calorimetric analyzes are performed with SEM, TEM, XRF, DSC imaging devices. Microbiological analysis we provide analysis services for pharmaceutical raw materials and finished products in accordance with EP-2.6.12 and EP-2.6.13 pharmacopoeia requirements.
We provide analysis service for pharmaceutical raw materials and finished products in accordance with EP-2.6.12 and EP-2.6.13 pharmacopoeia requirements.