Elemental Impurities
Maxxam offers heavy and other trace metals analysis in pharmaceutical drug products and dietary supplements of various types ranging from proteins and cytotoxic compounds to peptides and oligomers. Our heavy metals analysis service falls fully in line with the new USP Heavy Metals general chapters.
Utilizing ICP-MS and ICP-OES technology and microwave digestion sample preparation techniques, we are able to meet the requirements set out in the recently published USP Heavy Metals general chapters: USP <232>, USP <233> and USP <2232>.
Background
The traditional method for determining heavy metals in test articles is the classic colorimetric method outlined in USP <231>. This wet chemical technique involves the precipitation of metal sulfides from an aqueous solution, then visually comparing the color of the test sample with that of a standard lead solution.
Unfortunately, USP <231> method suffers from several drawbacks because it is:
• nonspecific
• insensitive
• time-consuming
• labor intensive
Furthermore, the old method consumes large amounts of the test article and often suffers from poor recovery of elements being tested.
For this reason, USP has published the proposed general chapters on Elemental Impurities Limits and Methods in the January-February issue of Pharmacopeial Forum PF 36(1).
Metals analysis at Maxxam
As 20+ year veterans in the application of Inductively Coupled Plasma Mass Spectroscopy (ICPMS), Maxxam’s scientists and analysts have been providing clients with Heavy Metals, Metal Catalysts and other trace elements testing in full compliance with GMP regulations; specifically, 21 CFR Parts 210 and 211 as well as EMEA and ICH guidelines. ICP-MS enables the analysis of up to 70 elements in a single sample at low ppt-ppb detection limits. In addition to the “Big Four” elements of Mercury (Hg), Lead (Pb), Arsenic (As) and Cadmium (Cd), ICP-MS also allows for analysis of 60+ other elements found in the periodic table including transition metals, precious metals and metalloids. USP <232> categorizes the Big Four elements as Class 1 requiring mandatory tests owing to their higher degree of toxicity. Class 2 elements such as Chromium (Cr), Copper (Cu), Manganese (Mn), Molybdenum (Mo), Nickel (Ni), Palladium (Pd), Platinum (Pt), Vanadium (V), Osmium (Os), Rhodium (Rh), Ruthenium (Ru) and Iridium (Ir) have less toxicity but do need to be tested if they are part of the manufacturing process. Metal Speciation Combining chromatographic techniques such as LC or GC with ICP-MS, speciation of elements such as mercury and arsenic, a key feature of the proposed USP<2232> chapter, is possible. Our technical team has been providing such speciation services for almost a decade.
