Elemental impurities analysis

ALS offers elemental impurities analysis of pharmaceutical products, ingredients, APIs and more. Equipped with the most sensitive technique available (high resolution ICP-MS) and decades of experience in metals testing of pharmaceuticals, ALS is a reliable partner in elemental impurities testing. Our laboratory can offer method development, method validation and analysis of almost all matrices and at levels far below established PDEs.

The ICH Q3D Guidelines for elemental impurities is a hot topic for all manufacturers of drug products. While guidelines have been in place for controlling organic impurities and residual solvents for a long time, a corresponding guideline for testing elemental impurities has been missing. This is a major reason as to why ICH Q3D has been implemented.

This means that the long established method for testing metals in pharmaceuticals, the colorimetric limit test, is a thing of the past. Both the USP, ICH and the Ph.Eur. suggest quantitative measurement of metals by ICP-MS and ICP-OES.

USP chapter <231>, Heavy Metals will be replaced by two new chapters <232> and <233>, Limits and Procedures.

Element testing capabilities at ALS Scandinavia:

Aluminium (Al) lodine (l) Samarium (Sm)
Antimony (Sb) Iridium (Ir) Scandium (Sc)
Arsenic (As) Iron (Fe) Selenium (Se)
Barium (Ba) Lanthanum (La) Silicon (Si)
Beryllium (Be) Lead (Pb) Silver (Ag)
Bismuth (Bi) Lithium (Li) Sodium (Na)
Boron (B) Lutetium (Lu) Strontium (Sr)
Bromine (Br) Magnesium (Mg) Sulfur (S)
Cadmium (Cd ) Manganese (Mn) Tantalum (Ta)
Caesium (Cs) Mercury (Hg) Tellurium (Te)
Calcium (Ca) Molybdenum (Mo ) Terbium (Tb)
Cerium (Ce) Neodymium (Nd) Thallium (Tl)
Chromium (Cr) Nickel (Ni) Thorium (Th)
Cobalt (Co) Niobium (Nb) Thulium (Tm)
Copper (Cu) Osmium (Os) Tin (Sn)
Dysprosium (Dy) Palladium (Pd) Titanium (Ti)
Erbium (Er) Phosphorus (P) Tungsten (W)
Europium (Eu) Platinum (Pt) Uranium (U)
Gadolinium (Gd) Potassium (K) Vanadium (V)
Gallium (Ga) Praseodymium (Pr) Ytterbium (Yt)
Germanium (Ge) Rhenium (Re) Ytterium (Y)
Gold (Au) Rhodium (Rh) Zinc (Z)
Hafnium (Hf) Rubidium (Rb) Zirconium (Zr)
Holmium (Ho) Ruthenium (Ru)  

Green cells: Elements included in both USP <232>, ICH Guidelines Q3D and Ph.Eur 5.20
Brown cells: Elements included ICH Guidelines Q3D only
Blue cells: “Other elements” specified in ICH Guidelines Q3D with low inherent toxicity for which no PDEs have been established.