GMP laboratory
GMP-compliant analytics in accordance with national and international pharmacopoeias or validated client methods.
Tentamus Pharma & Med’s contract laboratories offer a wide range of pharmaceutical analytics. In addition to GMP-compliant routine analytics such as pharmacopoeial analysis, elemental impurities testing, in vitro analysis for active substance release (dissolution testing), residual solvent testing, nitrosamine analytics, etc., we also develop and validate individual testing methods for products that are not (only) tested according to defined standards.
GMP laboratory
for tried-and-tested pharmaceutical analytics
Physico-chemical analysis
Our services in the field of physico-chemical analysis include testing pharmaceuticals for suspended solids, particle size and colour and determining osmolality and fluid content.
Instrumental analytics
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Atomic absorption spectrometry (AAS) and atomic emission spectrometry (AES)
using the following techniques: flame, nitrous oxide, graphite furnace, hydride and the corresponding digestion methods: acid digestion and microwave digestion to detect metals
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Inductively coupled plasma mass spectrometry (ICP-MS)
for trace analysis of heavy metals such as mercury, lead or cadmium
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Gas chromatography (GC)
with the following detectors: FID, NPD and MSD, e.g. determination of content and purity of pharmaceutical raw materials and finished products, residual solvents, fatty acid composition
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High-performance liquid chromatography (HPLC)
with the following detectors: mass spectrometer, UV/VIS, RI, ECD, fluorescence, DAD, e.g. determination of content and purity of pharmaceutical raw materials and finished products, biogenic amines and preservatives
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Ion chromatography (IC) with conductivity detection
for content determination of various anions and cations
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UV-VIS spectroscopy
for qualitative and quantitative determinations; especially enzymatics
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IR absorption spectroscopy
for the spectral recording of liquid and solid substances
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Thin-layer chromatography (TLC)
using a digital documentation system for the purpose of qualitative determinations and impurity testing
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Determination of Total organic carbon (TOC)
during purification processes, for example
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Amino acid analyzer
For the detection of ninhydrin-positive substances (amino acids) and their derivatisation products as well as ammonium by UV detection e.g. for the determination of identity, purity and content
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Capillary Electrophoresis (CE)
Used for the determination of the chirality of small molecules, Capillary Isoelectric Focusing (CIEF) or Capillary Gel Electrophoresis. For the determination of the purity, identity, and content of proteins (e.g. monoclonal antibodies)
