Category:
Active Pharmaceutical Ingredients
CAS NO:
102074-19-1
Standard:
EP,
Fumarate Impurity 1 refers to a specific degradation or synthetic byproduct associated with fumaric acid derivatives. Its molecular formula is typically C4H6O5, and it is often identified by CAS No. 297-07-0 (Malic Acid) in related contexts, though exact identity depends on the parent API. This impurity arises during esterification or hydrolysis processes.
Store in a cool, dry place away from oxidizers. Do not use in clinical formulations without validated purity data. Handle with appropriate PPE to avoid skin irritation. Strict adherence to GMP guidelines is required for pharmaceutical usage.