Elemental and Heavy Metal Screening
Quantitative Heavy Metal Screening by ICP-OES
When to Choose
This method covers impurities of the most common heavy
metals in organic compounds.
This quantitative and GMP-compliant method yields data
that can be readily used in registration dossiers.
Depending on the matrix, this method has better LOQs for
Fe, V, and Al than ICP-MS.
Determined Elements
Package 1: 18 elements (Al, As, Ba, Cd, Co, Cr, Cu, Fe, Mn, Mo,
Ni, Pb, Pd, Se, Sn, Ti, V, Zn)
Package 2: 21 elements (all Package 1 elements plus Bi, Pt, Sb)
Method
ICP-OES after a wet decomposition step
The method corresponds Ph. Eur. 2.2.57. (inductively coupled plasma-atomic emission spectrometry) and to USP method
<730> Plasma Spectrochemistry.
Limit of Quantitation
Typically 1 mg/kg for each element
Suitable Matrix
Organic compounds
Sample Amount
200 mg (single determination) or 400 mg (duplicate determination)
Available under GMP
Yes
Quantitative Determination of USP Heavy Metals by ICP-MS
When to choose
This method can be used as an alternative to the USP <231>
heavy metal test and the related Ph. Eur. 2.4.8 test, particularly when
quantitative and reliable values are required for each individual metal.
Determined Elements
Ag, As, Bi, Cd, Cu, Hg, Mo, Pb, Sb, Sn (mentioned in USP <231> Heavy Metals
as those elements that typically respond)
Method
ICP-MS after a wet decomposition step
The method complies with USP <730> Plasma Spectrochemistry.
Limit of Quantitation
Between 0.1 and 0.5 mg/kg for each element
Suitable Matrix
Organic compounds
Sample amount
200 mg (single determination) or 400 mg (duplicate determination)
Available under GMP
Yes
Semi-Quantitative Metal Screening by ICP-MS
When to choose
This method provides a general overview of metal and semi-metal traces in
organic samples covering the entire periodic table
For many elements this method has a better LOQ than ICP-OES.
Determined elements
All metals and semi-metals from lithium to uranium
Method
ICP-MS after a wet decomposition test.
Limit of quantitation
Between 0.1 and 1 mg/kg for each element, excluding Al, Ca, Fe and K
(LOQs between 1 and 10 mg/kg)
Suitable matrix
Organic compounds
Sample amount
200 mg (single determination)
Available under GMP
No
Semi-Quantitative Element Screening by XRF
When to Choose
This method provides a general overview of the elemental composition and
impurities of a sample.
Not limited to organic compounds.
Determined Elements
All elements from sodium to uranium, including Si, P, S, Cl, Br, and I.
Elements are classified into 4 categories:
• Major elements contributing >5% by weight
• Minor elements contributing 1–5% by weight
• Minor elements contributing >0.1–1% by weight
• Trace elements contributing <0.1% by weight
Identified elements can be quantified using WDXRF or other methods
upon request.
Method
Direct analysis by energy and wavelength dispersive X-ray fluorescence
spectrometry
The WDXRF method corresponds to the Ph. Eur. method 2.2.37 X-ray
Fluorescence Spectrometry
Limit of Quantitation
Between 1 and 50 mg/kg for each element, depending on element, amount
of substance and matrix
Suitable Matrix
Any kind of liquid and solid test material, even unknown materials such as
residues and abrasions
Sample Amount
0.1 to 4 g; best semi-quantitative classification is obtained with ≥ 3 g
Available under GMP
No
