Trace inorganic impurities in active pharmaceutical ingredients (APIs), with restricted toxicological significance, might affect the downstream processing properties as well as the quality of those substances.<br/>The aim of the present study was to examine inorganic impurities in common APIs ‘Paracetamol’ using Inductively Coupled Plasma Mass Spectrometry (ICP-MS). Low-level inorganic impurities at parts per billion (ppb) levels in paracetamol 500 mg tablets were investigated in order to identify whether same API produced in different country exhibits similar elemental composition or not. ICP-MS detected and quantified 28 elements in tablets manufactured in UAE, Saudi Arabia, Oman, Italy and Ireland.<br/>No significant differences were observed for Al, Cu, In, Fe, K, Zn, As, Be, Cd, Cs, Co, Li, Rb, Se, Ag, U, Pb impurities detected in tablets. Contrarily, Ca content was significantly different between tablets produced in Ireland and all other countries. Moreover, Na was significantly different between tablets made in both Italy and Saudi Arabia when compared to Oman or Ireland. Bi was found to be significantly different between drugs produced in Italy and those in Oman, UAE, Ireland and Saudi Arabia. Additionally, Ga, Sr, Mn, Cr and Ba impurities in tablets were also different depending on the country of origin. Finally, through ICP-MS analysis, we could provide the inorganic profiling of a common API produced in several countries. Altogether, these information could be helpful to identify the origin of the drug.

Analysis of low-level inorganic impurities in paracetamol tablets by ICP-MS

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