Determination of elemental impurities by ICP-MS
ALS offers GMP compliant elemental impurities analysis of pharmaceutical products,
ingredients, APIs and other healthcare products in accordance with compendia requirements.
Our facilities are equipped with some of the most sensitive techniques available coupled with
decades of experience specifically in metals analysis. Typical limits of quantification reach far
below typical PDE requirements; some reaching ppt (parts per trillion) levels with as little as
10mg in sample weight. Our facilities offer a full service range from initial scans to support pre-
risk assessment understanding to full and thorough ICH method validation. Our extensive
expertise allows for an open, collaborative approach towards managing each product and
project.
Elemental impurities in purified water
If purified water in bulk does not meet the requirement for conductivity prescribed for Water
for injections in bulk (Ph. Eur. Monograph 0169), a risk assessment according to Ph. Eur.
general chapter 5.20 should be carried out. The risk assessment should consider the role of
water in the manufacturing process, in particular when water is used in a process but is no
longer present in the final product. ALS can quickly and cheaply screen purified water, down to
very low limits of quantification, to support these risk assessments.
Contingency planning
It is realized many, particularly those manufacturing Active Pharmaceutical Ingredients
(API’s), will have their own analytical capability to manage elemental impurity testing. ALS can
help to mitigate risk by way of being a partner for independent analytical support and back-up.
Contingency planning can be a necessity to help navigate through rare but critical times of
need.
Clinical samples
Measuring the levels of metals in clinical samples, often referred to as biomonitoring, is
required in a variety of fields. Medicine, occupational health studies and therapeutic
research, to name but a few, all rely on such information. Due to the high toxicity of some
elements, measurements at very low levels are often required. ALS Luleå, Sweden has
considerable experience of analyzing human biological matrices using high resolution ICP-
MS (ICP-SFMS) and offer accredited analyses of 68 elements in whole blood, plasma, serum
and urine. Combined with isotope and elemental speciation capabilities, ALS offers a
comprehensive portfolio of elemental analysis for clinical samples.
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