Quality control
Each single batch of our produced radiopharmaceuticals is daily analyzed by quality control for the following parameters before it is released for clinical application:
• Identity |
testtext |
[HPLC, half-life, γ-spectrometry] |
• Radiochemical purity |
[radio-HPLC, radio-TLC] |
|
• Chemical purity |
(by-products /starting materials) |
[HPLC, TLC] |
(residual solvents) |
[GC/MS] |
|
• Radionuclidic purity |
[half-life, γ-spectrometry] |
|
• pH-value |
[pH-meter] |
|
• Osmolarity |
[Osmometer] |
|
• Microbiological purity |
(bacterial endotoxins) |
[LAL test] |
(sterility) |
[sterile test for sample A and B] |
|
• In process controls during production |
||
• Hygiene |
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