Nivolumab is a PD-1 blocking antibody used to indulgence of renal cell cancer, head and neck cancer ,melanoma, non small-cell lung cancer, and Hodgkin lymphoma. Nivolumab drug risk assessment and Analytical Method Validation were developed and analyzed for determination of Ag, As, Au, Ba, Cd, Co, Cr, Cu, Hg, Ir, Li, Mo, Ni, Pb, Pd, Pt, Rh, Ru, Sb, Se, Sn, , Tl ,V, Mg and Al by ICP MS. operated at standard mode, while pneumatic nebulization was used for introducing the sample solution into the ICP. Mercury was determined using cold vapor generation (CVG) coupled to ICP-MS. Chromium, Mn, Ni and V were detected by means of dynamic reaction cell-inductively coupled plasma mass spectrometry (DRC–ICP-MS). The operational conditions of each technique were optimized in order to achieve better sensitivity, precision and accuracy. The influence of the sample matrix, mainly carbon, on all investigated elements was evaluated. The use of DRC was effective to reduce interferences on Cr, Mn, Ni and V determination. The other investigated elements (As, Cd, Cu, Pb, Mo and Hg) were determined directly in the samples, which were properly diluted. Results obtained were in good agreement (between 96 and 105%) with certified values (certified reference materials of water were analyzed), at the same time as the relative standard deviation was lower than 5%. Sample throughput was relatively high (up to 30 samples of components used for parenteral nutrition solution could be analyzed per hour). In this way, the proposed method can be recommended for routine analysis.