A5030439252- Environmental Chemistry and Analysis
- Analytical Chemistry and Chromatography
- Analytical chemistry methods development
- Manufacturing Process and Optimization
Merck & Co., Inc., Rahway, NJ, USA (United States)
2022-2025
The development of robust manufacturing processes for active pharmaceutical ingredients (APIs) is paramount to ensure a supply safe and effective medications. Implementation holistic control strategy, including quality incoming raw materials, key element in meeting this goal. This paper describes several examples from recent Merck API routes, which impurities materials affected the various ways, giving rise new process impurities, jeopardizing safety causing damage reaction vessels,...
Sulfonate esters are encountered frequently as impurities that potentially mutagenic in different manufacturing processes producing active pharmaceutical ingredients (APIs) due to the widespread use of sulfonyl halide/anhydride or sulfonic acid reagents processes. While a scientific risk assessment, based on formation and predicted purge sulfonate esters, can justify absence these final API for some cases, other analytical testing data showing levels ester is required support assessment. The...