TABLE XVII

Qualitative Comparison of the Reported Findings with Specifications for Metallic or Elemental Impurities in Drug Products

Element	Included in the Relevant Reference?				General Findings in this Paper
Element	Ph. Eur.^¹	EMEA^²	USP^³	Other^⁴	General Findings in this Paper
Ag	—	—	—	X	Not extracted in reportable quantities from any material
Al	X	—	—	—	More frequently extracted, generally in low quantities
As	—	—	X	—	Not extracted in reportable quantities from any material
Au	—	—	—	X	Not targeted
B	—	—	—	X	More frequently extracted, generally in low quantities
Ba	X	—	—	—	Infrequently extracted, generally in low quantities
Be	—	—	—	—	Not extracted in reportable quantities from any material
Bi	—	—	—	—	Rarely extracted, generally in low quantities
Ca	X	—	—	—	More frequently extracted, occasionally in relatively higher quantities
Cd	X	—	X	—	Not extracted in reportable quantities from any material
Co	X	—	—	—	Not extracted in reportable quantities from any material
Cr	X	X	X	—	Rarely extracted, generally in low quantities
Cu	—	X	X	—	Rarely extracted, generally in low quantities
Fe	—	X	—	—	Infrequently extracted, generally in low quantities
Ge	X	—	—	—	Not extracted in reportable quantities from any material
Hg	—	—	X	—	Not targeted
Ir	—	X	X	—	Not targeted
Li	—	—	—	X	Not extracted in reportable quantities from any material
Mg	—	—	—	—	More frequently extracted, generally in low quantities
Mo	—	X	X	—	Not extracted in reportable quantities from any material
Mn	X	X	—	—	Rarely extracted, generally in low quantities
Na	—	—	—	—	More frequently extracted, occasionally in relatively higher quantities
Ni	—	X	X	—	Not extracted in reportable quantities from any material
Os	—	X	X	—	Not targeted
P				—	Infrequently extracted, generally in low quantities
Pb	—	—	X	—	Rarely extracted, generally in low quantities
Pd	—	X	X	—	Not targeted
Pt	—	X	X	—	Not targeted
Rh	—	X	X	—	Not targeted
Ru	—	X	X	—	Not targeted
S	—	—	—	—	More frequently extracted, occasionally in relatively higher quantities
Sb	X	—	—	—	Rarely extracted, generally in low quantities
Se	—	—	—	X	Rarely extracted, generally in low quantities
Si	—	—	—	—	More frequently extracted, occasionally in relatively higher quantities
Sn	X	—	—	—	Not extracted in reportable quantities from any material
Sr	—	—	—	—	Rarely extracted, generally in low quantities
Ti	X	—	—	—	Not extracted in reportable quantities from any material
V	X	X	X	—	Not extracted in reportable quantities from any material
W	—	—	—	X	Not targeted
Zn	X	X	—	—	More frequently extracted, occasionally in relatively higher quantities
Zr	X	—	—	—	Not extracted in reportable quantities from any material

↵Notes: ¹Chapter 3. Materials for Containers and Containers (14).
↵2 Guideline on the Specification of Limits for Residues of Metal Catalysts or Metal Reagents (15).
↵3 Chapter <232> Elemental Impurities— Limits, Table 1 (16).
↵4 Elements in this column are not cited in the references for the first three columns but may be relevent from a safety or product impact assessment perspective.