Article: Raw Material Characterization, How Pure is Pure?
Raw material characterization plays an important part in the quality control process of product manufacture or development, ensuring that contaminants, residual solvents, catalysts, water, particles, and/or degradants meet specifications. As the uses for chemicals have become more specialized, and processes become more regulated, the demand for highly pure starting or raw materials has increased in numerous industries including electronics, pharmaceuticals, and specialty chemicals.
For any of these industries, the purity of a starting material or solvent is of extreme importance, with specifications in the part-per-billion for levels of impurities, and in some cases in the part-per-trillion levels. Techniques that utilize mass spectrometry are routinely used to detect heavy metals, residual solvents, process impurities, and other unwanted materials. In order to detect thesecomponents at low levels, the sample preparation method may be the key to the analysis and detection limits. Analyzing a sample neat, or without dilution aids in a lower detection limit.
In the electronics/semiconductor industries, newer technology and design means thinner coatings, which in turn means, that the reduction of unwanted metals or interfering elements is imperative. Raw materials and samplings from processes can be monitored by inductively coupled plasma using either optical emission spectroscopy or mass spectrometry (ICP-OES, ICP-MS), achieving detection limits of part-per-billion levels or lower. For example, different grades of silicon can be evaluated for the presence of other metals. Because hydrofluoric acid (HF) is required for digestion of silicon, ICP-OES may have to be used for analysis. In addition, the Restriction of Hazardous Substances (RoHS) Directive sets limits on the amount of lead, mercury, and cadmium in electronics and electronics waste, all of which can be monitored by ICP.
The pharmaceutical industry relies on analysis of the starting materials, solvents, and drug product to detect drug and process impurities. As these impurities can ultimately affect a patient, analysis for these substances requires instrumentation that can achieve ppm to ppb levels. Mass spectrometry, combined with liquid chromatography or gas chromatography (LC-MS, GC-MS), are the tools of choice when analyzing for these low level impurities.
Specialty chemicals support all of these industries, and as the demand for more pure chemicals increases, the changes in specifications requires lower analytical detection limits. Separations with mass spectrometry, such as LC-MS and GC-MS, are used most commonly for these analyses. The mass spectrometer, combined with extensive libraries, or accurate mass capabilities, provides information for identification of unknowns or confirmation of possible known impurities.
Impact Analytical has a full suite of analytical capabilities to characterize all classes of raw materials. We have the experience to develop and validate new methods for characterization. We can transfer these methods to the client, or if needed, provide raw material support on a routine basis.
When you work with us, our experts will first consult with you to determine your specific needs. Discussions will include types of chemical analyses required, sample amounts, sample solubility, sample handling restrictions, and level of reporting required. We have extensive experience working in a regulatory environment, such as GLP/cGMP, and reporting for Federal agency (FDA and EPA) requirements in the United States, or REACH reporting for European Union requirements.
Examples of raw materials we have experience characterizing include:
- Drug Product Excipients
- Solvent Purity
- Drug Substance Intermediates
- Catalyst Materials
Contact us today to discuss your raw material characterization needs.