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 (IC-PMS), 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.

  • Arsenic: As(III), As(V), Methyl- As, Dimethyl-As
  • Chromium: Cr(III), Cr(VI)
  • Mercury: Methyl-Hg, Hg(II)
  • Selenium: Se(IV), Se(VI)

By

Donna Garbutt, M.B.A. Chief Executive Officer Maxxam is the Canadian market leader in analytical services and solutions to the energy, environmental, food and DNA industries and a member of the Bureau Veritas Group of companies – a world leader in testing, inspection and certification services. We support critical decisions made by our customers through the application of rigorous science and the knowledge and expertise of our over 2200 employees. Our annual Corporate Responsibility Report outlines our efforts to continually improve our business performance and practices. Its publication is an industry first and an integral part of our commitment to success with responsibility. LinkedIn
Maxxam Analytics Maxxam is the Canadian market leader in analytical services and solutions to the energy, environmental, food and DNA industries and a member of the Bureau Veritas Group of companies – a world leader in testing, inspection and certification services. We support critical decisions made by our customers through the application of rigorous science and the knowledge and expertise of our over 2200 employees. Our annual Corporate Responsibility Report outlines our efforts to continually improve our business performance and practices. Its publication is an industry first and an integral part of our commitment to success with responsibility.
500 – 1919 Minnesota Ct., Mississauga, Ontario L5N 0C9
Phone: (905) 288-2150