Trace, Heavy Metals and
Elemental Impurities Testing
Although controlling heavy metals and elemental impurities has always been a critical issue for the pharmaceutical industry, stricter limits and procedures are now in place by regulators and compendia. For 25 years Quantex has been involved with developing and executing methods for trace and heavy metals analysis employing modern quantitative technologies.Our scientists have developed and validated GMP analytical methods employing flame and graphite furnace atomic absorption, ICP-OES and ICP-MS methods. These validated methods have been employed to assess the presence of heavy/trace metal and elemental impurities in API, drug product, medical device, biological tissue, raw materials, excipients, cosmetic products, and more.
Our laboratories are equipped with state of the art instrumentation which provide both the capabilities and flexibility in meeting the challenges that varying matrices present in the quantitative analysis of trace metals and elemental impurities. Our scientists develop analytical methods that are robust, transferable, reproducible, and designed to support and meet regulatory requirements and submissions.
Quantex’s method development services ensure that your team makes the best decisions and hits drug development milestones on time and on budget. Our approach is to work closely with each client collaboratively, to fully understand both the requirements of the method and the nature of the drug, product or device. Then, through our unique blend of experience, expertise, and focus we evaluate parameters and identify critical quality attributes. This allows us to develop methods that are robust, efficient, fit for purpose, ranged properly, and that can be quickly validated.
Our AAS, ICP-OES and ICP-MS Systems Can Detect & Measure :
- Aluminum, Antimony, Arsenic
- Barium, Beryllium, Bismuth, Boron
- Cadmium, Calcium, Chromium, Cobalt, Copper.
- Germanium, Gold
- Iron, Indium, Iridium.
- Lead, Lithium, Lanthanum
- Magnesium, Manganese, Mercury, Molybdenum
- Palladium, Platinum
- Potassium, Phosphorus
- Rhodium, Ruthenium
- Selenium, Silicon, Silver, Sodium
- Tin, Titanium, Thallium, Tungsten
- Zinc, Zirconium