By Navin Saxena Research and Technology Pvt. Ltd.
Identifying and describing the impurities that are present in the API is important for safety reasons. Generally, unknown impurities have a more stringent limit for regulatory submissions. By identifying these unknown impurities, the limits could be relaxed, the origin of the impurity can be established, thereby improving the process controls and the API’s impurity profile. At NSRT, we can help you isolate, identify and synthesize and provide a well characterized and certified impurities present in the API.
