related substances / impurities – degradation products and other impurities (e.g. residual solvents, chiral purity)
identification of unknown impurities
vitamins analysis
preservatives and antioxidants analysis
dyes analysis
water content determination
metal analysis (as impurities)
macro-and microelements analysis
leaching and leaking tests of primary packaging materials
dissolution tests
process equipment cleaning verification and validation (with swab or rinse method)
We offer comprehensive analysis of materials (active substances and excipients) and pharmaceutical products in accordance with relevant pharmacopoeial monographs (FP, EP, BP, USP/NF) or customer specifications.
Analytical techniques
Analyses are conducted with suitable techniques corresponding with intended purpose. Depending on the needs, we use classical and instrumental techniques, such as:
capillary gas chromatography (GC) with flame ionization detector (FID) and thermal conductivity detector (TCD)
direct sample injection setup
headspace type injection setup
high-performance liquid chromatography (HPLC) and ultra high-performance LC (UHPLC) with UV/Vis (DAD) detection
UV/Vis spectrophotometry
IR spectrophotometry
atomic absorption spectrometry (AAS) with flame (F-AAS) and flameless atomization (graphite furnace; GF-AAS), cold vapour (CV-AAS) and hydride generation (HG-AAS) techniques, as well as atomic emission spectrometry (AES).
