In previous articles, you may recall that Amanda Rigdon, one our contributing authors, stated that instrument calibration is the foundation of all data quality. In this article, I would like to expand on that salient point. A properly calibrated instrument will, in fact, produce reliable data. It is the foundation we build our data upon. All foundations are comprised of building blocks, and our laboratory is no exception. If we take this analogy further, the keystone to the laboratory foundation, the stone that all data relies upon, is the analytical reference material. Proper calibration means that it is based on a true, accurate value. That is what the reference material provides. In this article, I would like to expand on the use and types of reference materials in analytical testing.
To develop sound analytical data, it is important to understand the significance of reference materials and how they are properly used. The proper selection and use of reference materials ensures the analytical certainty, traceability and comparability necessary to produce scientifically sound data. First, let’s take a moment to define the types of commonly used reference materials. According to the International Vocabulary of Metrology (VIM), a Reference Standard (RS) is something that is reused to measure against, like a balance or a set of weights. A Reference Material (RM) is a generic term. It is described as something that is prepared using a RS that is homogeneous, stable and is consumed during its use for measurement. An example of an RM is the solutions used to construct a calibration curve, often referred to as calibration standards, on your GC or LC. Due to the current state of cannabis testing, reference materials can be hard to find and, even more critical, variable in their accuracy to a known reference standard. Sometimes this is not critical, but when quantifying an unknown, it is paramount.
RMs can be either quantitative or qualitative. Qualitative RMs verify the identity and purity of a compound. Quantitative RMs, on the other hand, provide a known concentration, or mass, telling us not only what is present, and its purity, but also how much. This is typically documented on the certificate that accompanies the reference material, which is provided by the producer or manufacturer. The certificate describes all of the properties of the starting materials and steps taken to prepare the RM. For testing requirements, like potency, pesticides, etc., where quantitation is expected, it is important to use properly certified quantitative RMs.
Now, the pinnacle of reference materials is the Certified Reference Material (CRM). VIM defines a Certified Reference Material (CRM) as an RM accompanied by documentation issued by an authoritative body and provides one or more specified property values, with associated uncertainties and traceability using valid procedures. A CRM is generally recognized as providing the highest level of traceability and accuracy to a measurement – the strongest keystone you can get for your foundation. It is also important to recognize that the existence of a certificate does not make a reference material a CRM. It is the process used in manufacturing that makes it a CRM, and these are typically accreditations earned by specific manufacturers who have invested on this level of detail.
Now that we understand the types of reference materials we can choose, in the next article of this series we will describe what a CRM provider must do to ensure the material and how we can use them to develop reliable data. Without properly formulated and prepared CRMs, instrument calibration and the use of internal standards are less effective at ensuring the quality of your data.
If you have any questions please contact me, Joe Konschnik at (800) 356-1688 ext. 2002 by phone, or email me at joe.konschnik@nullrestek.com.