Single Method Approach for Pharmaceutical Residual Solvent Analyses Using High-Temperature Static Headspace
by Brian Wallace, Applications Chemist
Many different chemical solvents are utilized in pharmaceutical manufacturing processes. In an effort to protect the health of the patient, pharmaceutical companies are adopting methodologies that will reduce the toxicity of solvents used in the preparations of drug products. The International Conference on Harmonization (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use has published guidelines on a list of 61 solvents with their daily exposure limits.1 Each of these solvents have been assessed and classified according to their permitted daily exposure toxicity.
•Class 1 residual solvents are known carcinogens or environmental hazards and are typically avoided in pharmaceutical manufacturing.
•Class 2 residual solvents cause some reversible or irreversible toxicity but are less toxic than class 1. These solvents are limited in their use in pharmaceutical manufacturing.
•Class 3 residual solvents have a low toxic potential or have no health-related exposure limit.
All pharmaceutical products must be analyzed for residual solvents regardless of class and toxicity. In regards to the analysis of ICH residual solvents, difficulties have occurred in finding a matrix in which all of the residual solvents can be successfully analyzed. The diversity of potential matrices has given rise to a plethora of analytical methods to analyze all the potential residuals in a wide variety of product matrices. The multitude of methods has created a significant cost and complexity barrier to the establishment of residual solvent compliance on a global basis.
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