ICP or Inductively Coupled Plasma testing is an analytical technique used to measure and identify elements ranging from trace levels to higher concentrations in raw materials, finished products, excipients, API (Active Pharmaceutical Ingredients), water, and others whether the materials are organic or non-organic, aqueous, or non-aqueous. This elemental analysis which includes heavy metals testing, is critical for ensuring product quality, safety, and compliance with regulatory standards. Testing by ICP-MS was enforced by the USP (United States Pharmacopeia) as of January 1, 2018, when general wet chemistry was deemed to no longer be a viable method. NJ Labs is experienced and skilled in ICP-MS metals assays & elemental analyses and we will work with you to meet your testing requirements.
ICP-MS is an acronym for Inductive Coupled Plasma Mass Spectroscopy. ICP-MS is an analytical instrument that combines inductive coupled plasma technology with mass spectroscopy for elemental analysis by generation of ions.
It combines a high temperature Inductively Coupled Plasma (ICP-MS) source with a mass spectrometer (MS). The ICP source converts the atoms of the elements in the sample to ions that are separated and detected by mass spectrometer. The ICP-MS combines multi-element capabilities with detection limits equivalent or below that of GFAA and can obtain isotopic information. The instrument can detect metals at parts per billion (ppb) and parts per trillion (ppt) levels.
ICP-MS is a high-tech addition to elemental analysis that can replace more conventional instrumentation, such as atomic absorption, which has been around for many years, and is not very sensitive. However, given the sensitivity and reliability of ICP-MS testing, the FDA has been recommending it more frequently. Companies requiring ICP-MS testing must often create an ICP-MS protocol for a method and submit the protocol along with the product to a laboratory. However, at New Jersey Laboratories, we specialize in developing and validating custom methods for your products according to your specifications and then creating and writing ICP-MS protocols for you. We write comprehensive protocols which have satisfied regulatory requirements, and we work closely with our clients during the entirety of the project, which includes explaining our process every step of the way. Our reporting process is detailed, complete and designed to withstand FDA scrutiny.
ICP-MS can detect nearly all elements in the periodic table, including metals, non-metals, and metalloids. Here are some of the key categories of elements that ICP-MS can detect:
ICP-MS provides extremely low detection limits, often in the parts per billion (ppb) or even the parts per trillion (ppt) range, making it suitable for trace and ultra-trace analysis of elements in a wide range of sample types, including pharmaceuticals, cosmetics, nutraceuticals, food & beverage analysis, and clinical research.
USP General Chapters <232> and <233> are specific chapters within the United States Pharmacopeia (USP) that provide guidelines and standards for elemental impurities in pharmaceuticals and supplements. NJ Labs performs compliance testing for elemental impurities based on these chapters to ensure the safety and quality of all products.
Compliance with USP General Chapter<232> and <233> is a critical aspect of pharmaceutical quality control and assurance. Together, these chapters establish a framework for assessing and controlling elemental impurities to safeguard patient safety and product quality. Manufacturers and regulatory agencies use these guidelines to perform elemental analysis and validate compliance with the specified limits for elemental impurities in pharmaceuticals. Their implementation is essential for regulatory compliance and helps ensure that pharmaceutical products do not contain harmful levels of elemental impurities such as heavy metals like lead, mercury, cadmium, and arsenic, which could pose health risks to consumers.
This depends upon the sample. While some water-soluble samples may not require digestion, most samples must be digested in a minimal acid solution that preserves the sample’s volatile elements. However, when we do digest samples, we use microwave digestion which dissolves the sample to extract metals in the sample.
