Applications of PAT to crystallization processes
by FDA Center for Drug Evaluation and Research
This white paper by the Food and Drug Administration's Center for Drug Evaluation and Research describes the application of process analytical technology (PAT) to crystallization processes, using reviews of several case studies. Crystallization of active pharmaceutical ingredients (APIs), particularly those that posses multiple polymorphic forms, is among the most critical and least understood pharmaceutical manufacturing processes. A variety of in situ analytical methods, combined with chemometric tools for analysis of multivariate process information, provide a basis for improvements in modeling, simulation and control of crystallization processes.
| Published: | 2003 |
| Format: | |
| Length: | 46 pages |
| Type: | White paper |
| Language: | English |
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