Abstract
Ropivacaine hydrochloride monohydrate is prolonged acting amide local anesthesia. In its guidelines, the International Conference on Harmonization notes that elemental inorganic contaminants may enter active pharmaceutical ingredients and drug formulations from various causes. Arsenic, mercury, cadmium, mercury, and lead are examples of class 1 elements, which occur as inorganic contaminants that have hazardous effects on the human body. During the synthesis of ropivacaine hydrochloride monohydrate, palladium assisted as a catalyst. A simple, reliable, and reproducible inductively-coupled plasma mass-spectrometric (ICP-MS) method for assessing trace metals in ropivacaine hydrochloride monohydrate by open vessel acid digestion method was established and validated. All of the elements' limits were set by ICH Q3D.
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