Elemental Impurities
The ultimate metal-free detection
Solvias is future proofed for the continuously increasing requirements for limits of
detection and repeatability in trace element analysis. Our ICP-MS screenings detect to
the lowest level possible, and assess at all limits listed in the “Guidelines for Elemental
impurities” of ICH Q3D, which is soon to be aligned with USP and Ph. Eur. With our expertise, metal-free facilities and leading edge technology, we can ensure that if there
are any elemental impurities - we will for sure detect them.
You can choose your elements in any combination,
using a standardized package or competitively priced
options for multiple determinations.
ICP-MS – the gold standard
Package 4 (ICH Q3D Class 1, “Big four”)
As, Cd, Hg, Pb
Package 7 (ICH Q3D Class 1 + 2A)
As, Cd, Co, Hg, Ni, Pb, V
Package 16 (ICH Q3D Class 1 + 2A + 2B, without Os)
Ag, As, Au, Cd, Co, Hg, Ir, Ni, Pb, Pd, Pt, Rh, Ru, Se, TI, V
Package 23 (ICH Q3D Class 1 - 3, without Os)
Ag, As, Au, Ba, Cd, Co, Cr, Cu, Hg, Ir, Li, Mo, Ni, Pb, Pd, Pt, Rh, Ru,
Sb, Se, Sn, TI, V
Package 33 (all elements listed in USP <232>, Ph. Eur. 5.20 and
ICH Q3D, plus frequently requested elements, without Os)
Ag, Al, As, Au, B, Ba, Cd, Ce, Co, Cr, Cs, Cu, Fe, Hg, Ir, Li, Mn, Mo,
Ni, Pb, Pd, Pt, Rh, Ru, Sb, Se, Sn, Ti, Tl, V, W, Zn, Zr
All packages are also available including Os, which needs to be
determined separately.
Technical details:
• Method: ICP-MS after digestion
• Compliant with USP <233>, <730>, Ph. Eur. 2.4.20, 2.2.58
• Limits of quantitation: usually 0.01 to 0.5 mg/kg
• Sample amount: 200 mg (single determination)
• Suitable for most organic samples, aqueous samples and
inorganic samples
• Release analysis / QC
In case the generally validated method does not meet your
needs, product-specific validation is available on request. For
unknown samples, especially inorganic excipients, spiking
experiments are recommended, e.g. at 30 % and 100 % of
specification limit according to ICH Q3D.
regulatory framework
ICH Q3D Guideline for Elemental Impurities
United States Pharmacopoeia
<232> Elemental Impurities – Limits
<233> Elemental Impurities – Procedures
<730> Plasma Spectrochemistry
European Pharmacopoeia
2.2.57 Inductively coupled plasma-optical emission spectrometry
2.2.58 Inductively coupled plasma-mass spectrometry
2.4.20 Determination of metal catalysts or metal reagent residues
5.20
Metal catalysts or metal reagents residues
Japanese Pharmacopoeia
<2.63> Inductively Coupled Plasma-Atomic Emission Spectrometry and
Inductively Coupled Plasma-Mass Spectrometry
FEI-0815-2
ICP-OES – the robust alternative
Package 18 (USP <730>; Ph. Eur. 2.2.57)
Al, As, Ba, Cd, Co, Cr, Cu, Fe, Mn, Mo, Ni, Pb, Pd, Se, Sn, Ti, V, Zn
Package 21 (Package 18 plus 3 frequently requested elements)
Al, As, Ba, Cd, Co, Cr, Cu, Fe, Mn, Mo, Ni, Pb, Pd, Se, Sn, Ti, V, Zn
+ Bi, Pt, Sb
Packages 18 and 21 cover the most common heavy metal
impurities which may be present in organic compounds,
yielding quantitative fast and reliable results by ICP-OES.
Technical details:
• Method: ICP-OES after digestion
• Compliant with USP <730>, Ph. Eur. 2.2.57
• Applicable for organic samples:
limit of quantification is 1 mg/kg for each element
• Sample amount: 200 mg (single determination)
Why Solvias?
• Over 30 years of experience in ICP-MS
• Metal-free sample preparation guarantees maximum reduced
false positive
• Latest technologies secures detection to the lowest possible
level of element impurity
• Capacity to handle large volumes with a quick turnaround
Metal free lab detail: Glove box compartment for weighing and
sample predigest.
Contact Headquarters
Solvias AG, Römerpark 2, 4303 Kaiseraugst, Switzerland
Tel. +41 61 845 60 00, info@solvias.com
Contact North America
Solvias Inc., 125 Center Avenue, Suite 507, Fort Lee, NJ, 07024, USA
Tel. +1 201 302 6084 / toll free 866-4-SOLVIAS, info@solvias.com
www.solvias.com