USP/ICH Elemental Impurities Standards Kit - Oral PDEs

In conjuction with our United States Pharmacopeia (USP) calibration standards, we offer six calibration standards for the analysis of metals in pharamceutical materials and products.

ICH Class 1 Elements + Tl - Oral PDE:

• 30 ug/mL Hg
• 15 ug/mL As
• 8 ug/mL Tl
• 5 ug/mL Cd, Pb
• Matrix: 5% HNO₃/2% HCl (N9304362)

ICH Class 2A Elements - Oral & Parenteral PDEs:

• 200 ug/mL Ni
• 100 ug/mL V
• 50 ug/mL Co
• Matrix: 2% HNO₃ (N9304363)

• 100 ug/mL Au
• Matrix: 2% HCl (N93033728)

ICH Class 2B Precious Metal Elements (no Os) - All PDEs:

• 100 ug/mL Ir, Pd, Pt, Rh, Ru
• Matrix: 15% HCl (N9304364)

ICH Class 2B Se & Ag - Oral PDE:

• 150 ug/mL Ag, Se
• Matrix: 2% HNO₃ (N9304365)

ICH Class 3 Elements - Oral PDEs:

• 1100 ug/mL Cr
• 600 ug/mL Sn
• 300 ug/mL Cu, Mo
• 140 ug/mL Ba
• 120 ug/mL Sb
• 55 ug/mL Li
• Matrix: 5% HNO₃/tr Tart/tr HF (N9304366)

Internal Standards - All PDEs:

• 50 ug/mL Ge
• 20 ug/mL Ga
• 1 ug/mL In, Tb
• Matrix: 2% HNO₃ (N9304367)