Testing for Trace Metals in Excipients

Many metals can be toxic and have negative effects on human, animal and plant health and the environment. Trace metal testing is conducted to ensure that the metal content in the sample complies with legal and regulatory requirements. In the pharmaceutical industry, trace metal analysis is used in quality control to identify and measure metal contaminants in products. Metal analysis is also used in formulation studies and to improve production processes due to the effect metals can have on different chemical reactions. Even small amounts of metals in excipients can affect formulation stability and catalyst degradation. A comprehensive understanding of the elemental composition of an excipient or formulation helps ensure product quality and purity. BOC Sciences' elemental testing and analytical experts have extensive experience in the analysis of pharmaceutical organic and inorganic elements. Trace metal elemental testing is routinely performed in our laboratory and is performed according to pharmacopeial methods.

Our Services

• Analytical equipment with high sensitivity supports the analysis of lead (Pb), mercury (Hg), arsenic (As), cadmium (Cd), copper (Cu), nickel (Ni), zinc (Zn) and other potentially toxic elemental impurities
• Metals in a sample are usually measured in ppm, ppb or even ppt (parts per trillion), depending on the complexity of the sample and the analytical technique used
• Additional toxicology risk assessment and testing compliance services

Figure 1. Concentration Range of ICP–MS Calibration and Limit of Detection. (Umamaheswari, D.; et al. 2021）

Testing Procedure

Our experienced analysts apply strategic methods to sample preparation for some samples with low solubility using a range of analytical techniques relevant to your needs, including inductively coupled plasma-mass spectrometry (ICP-MS) or inductively coupled plasma-optical emission spectroscopy (ICP-OES), flame atomic absorption spectrometry (FLAA), and atomic absorption spectroscopy (AAS).

Sample Digestion

We perform the digestion process using the following methods, depending on the matrix and the sample:

• Dissolved in aqueous solutions (mostly acidified)
• Dissolved in organic solvents
• Extraction
• Open digestion
• Microwave digestion

Spectrometric Measurement Techniques

BOC Sciences supports a range of spectroscopic measurement techniques for the accurate characterization and quantification of trace metals in excipients.

• Atomic Absorption Spectroscopy (AAS)

In AAS, element-specific radiation of metals is absorbed by interaction with free atoms, which can be used for quantitative and qualitative determination of many metal elements. We mainly use AAS for testing and analysis of a high proportion of the sample matrices and up to 100% organic solvents.

• Inductively Coupled Plasma - Optical Emission Spectroscopy (ICP-OES)

ICP-OES is ideally suited for quantitative elemental determination or qualitative overview analysis up to the moderate trace levels. We provide analysis services for more than 70 metals elements at concentrations of about 10 ppb.

• Inductively Coupled Plasma - Mass Spectrometry (ICP-MS)
• More than 70 metal element analysis
• Isotope analysis
• 1 to 0.001 ppb analytical detection limit range

• Flame Atomic Absorption Spectrometry (FLAA)
• Large amount of sample analysis
• Short analysis time
• 100 to 1 ppb analytical detection limit range

• Graphite Furnace - Absorption Spectrometry (GFAA)
• High sensitivity
• Limited element interferences
• 1 to 0.001 ppb analytical detection limit range

• Cold Vapor - Absorption Spectrometry (CVAA)
• Excellent sensitivity
• Limited element interferences
• Rapid analysis time

Why choose BOC Sciences Trace Metal Testing?

• Years of experience in developing and performing trace metal analytical methods using modern pharmaceutical quantification techniques
• Our metals analysis team has extensive expertise to solve complex sample matrices and method challenges
• Our rich regulatory experience allows the team to help you determine the most appropriate testing method, and provides services that meets your needs
• BOC Sciences’ elemental analysis lab is equipped with state-of-the-art instrumentation allowing for fast turnaround times