Module 3 - Strategic case studies in practice

ICH Q3D(R1) Guideline

Table A.2.2: Permitted Concentrations of Elemental Impurities for Option 1 The values presented in this table represent permitted concentrations in micrograms per gram for elemental impurities in drug products, drug substances and excipients. These concentration limits are intended to be used when Option 1 is selected to assess the elemental impurity content in drug products with daily doses of not more than 10 grams per day. The numbers in this table are based on Table A.2.1.

Element

Class

Oral Concentration µg/g

Parenteral Concentration µg/g

Inhalation Concentration µg/g

Cd Pb As Hg Co Ni Tl Au Pd Os Rh Ru Se Ag Pt Li Sb Ba Mo Cu Sn V Ir

1 1 1 1

0.5 0.5 1.5

0.2 0.5 1.5 0.3 0.5

0.3 0.5 0.2 0.1 0.3 0.1 0.5 0.8 0.1 0.1 0.1 0.1 0.1 0.1 0.7 0.1 2.5 13

3 5

2A 2A 2A 2B 2B 2B 2B 2B 2B 2B 2B 2B 2B

10 20

1 2

0.8

0.8

10 10 10 10 10 10 15 15 10 55

10

1 1 1 1 1 8 1 1

3 3 3 3 3 3 3

25

120 140 300 300 600

9

2

70

30

150

1 3 6

30 60

Cr

1100

110

0.3

26