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Good manufacturing practice production of the system A amino acid transport tracer [ 11 C]MeAIB on a commercial synthesis module
Author(s) -
Dam Johan Hygum,
Någren Kjell
Publication year - 2014
Publication title -
journal of labelled compounds and radiopharmaceuticals
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.432
H-Index - 47
eISSN - 1099-1344
pISSN - 0362-4803
DOI - 10.1002/jlcr.3139
Subject(s) - chemistry , isobutyric acid , bioburden , chromatography , tracer , by product , raw material , organic chemistry , medicine , physics , surgery , nuclear physics
In this report, an automated 11 C‐ N ‐methyl‐ α ‐amino‐isobutyric acid production on a Tracerlab FX C Pro module is described. Bioburden to the sterile filter was minimized during solid‐phase extraction formulation of the HPLC purified product by the use of sterile aqueous solutions. The optimized solid‐phase extraction formulation conditions are fast, give a high recovery of the product, and effectively remove organic solvents and adjust the pH. The final product was obtained within 30–35 min, delivering 1.5–5 GBq in 10 mL sterile phosphate buffer. The product fulfills in every respect our stringent batch release specifications including residual solvents, bioburden, and sterility. The robustness of the automated 11 C‐ N ‐methyl‐ α ‐amino‐isobutyric acid production has been demonstrated during more than 40 productions for preclinical use without any failures in regard to product amounts or release specifications. Copyright © 2013 John Wiley & Sons, Ltd.