Heavy Metal Elemental Analysis
Elemental and Trace Metal Analysis can be carried out in accordance to Pharmacopoeia USP 232 or Ph. Eur. 2.4.8 or USP <231> or to specific customer requirements.
The term "heavy metal" is not scientifically well-defined. Different elements may be classified here depending on the classification criteria (density, number of periods, etc.). Technically, any metal with a density greater than 5 g/cm3 is considered a heavy metal. "Heavy metals" usually means toxic elements, however, this is only partially true, as the small amounts of elements essential to human life also fall into this category.
If testing is not performed for a specific heavy metal, the most common source of evidence nowadays come from a limit test being carried out. After treatment, the heavy metal is complexed with thioacetamide or precipitated as a sulphide. Then, one compares the resulting colouring of the sample solution against that from a reference lead solution.
These limit tests still form the majority of testing for heavy metals in the current national and international Pharmacopoeias (e.g. Ph. Eur. 2.4.8 or USP <231>). Thereby, it is possible however to make only a semi-quantitative statement about the total contents of heavy metals in the sample, and in addition - and additionally, only for those heavy metals that actually form dark coloured complexes or sulphides.
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Spectroscopic tests are to be found only in individual monographs and methods (e.g. nickel in polyols and oils, lead in sugar) to date.
There is no sign of any changes in the near future with regard to the methods in the Ph. Eur. and JP. This is in contrast to the US Pharmacopoeia.
The USP lists limit values for 15 heavy metals. It should be observed that it is not always necessary to investigate all of these. After a risk-based estimation, determination is restricted to those elements which could unintentionally end up in the end product either through natural methods, or by being added (e.g. catalysts). Excluded from this are the so-called “bad 4”, arsenic, lead, cadmium and mercury which must always be integrated into the risk evaluation.
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