Main parameters of enriched Oxygen-18 water are tested routinely during the production process. The quality of each final batch of water 18 tested in independence laboratories that have international certification. For each batch independents laboratories make new quality certificate and signed by heads of this laboratories.
The isotope content on a gas was determined by mass spectrometer ionization impact ÌÈ-1201Â. Accuracy for O-18 is ±0.2 Atom %, for enriched higher than 80 Atom %.
The chemical content of water-18 specimen was determined by the mass spectrometer with inductive connected plasma ICP MS. The Hp-4500 ICP MS manufactured by Hewlett Packard device is applied.
Deuterium by mass-spectrometer DELTA.
Tritium by Liquid Scintillator Analyzer.
TOC (Total Organic Control) measures at the plant by TOC Analyzer of Japan company Shimadzu.
pH by pH meter.
Conductivity by Conductometer.
Pyrogenicity is determined on the plant by using LAL test for endotoxin detection by international technique. Kinetic-QCL Testing is performed according to SOP 162.6. Not only measurements are made on the plant, samples of water-18 are also tested by LAL test in USA in LAL Testing Service Cambrex Bio Science Walkersville, Inc. All results suits to all FDA requirements.
Sterility is approved by tests conducted according to requirements of USP XXV.
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