Nitrosamines are a well-known group of highly potent, mutagenic impurities formed by the reaction of secondary amines with nitrite under acidic conditions. Nitrosamines have been studied for many years due to their presence ... read more

According to ICH Q7, a starting material is defined as the point at which the sponsor commits to GMP manufacture of a drug substance. Drug substance processes are generally convergent and each branch of the synthesis begins ... read more