Elemental Impurities – Excipient Realities and Challenges
ppm Ca ppm Total Pb ppm Inorgani c Hg ppm Cr ppm Cu ppm Nil ppm TITANIUM DIOXIDE, USP/FCC/EP/JP Supplier A 1.0 max 0.2 max 10.0 max 1.0 max 1.9 max 0.5 max N/A TITANIUM DIOXIDE USP/EP/JP Supplier B 3.0 max 1.0 max 10.0 max 1.0 max N/A N/A N/A CALCIUM CARBONATE EP Supplier C 3 max 1 max 10 max N/A N/A N/A N/A CALCIUM CARBONATE USP - …