Chemicals and reagents play a critical role in the manufacturing and testing of pharmaceutical products, medical devices, biologics, cell- and tissue-based products, and many other healthcare-related solutions. Laboratories and researchers who use chemicals and reagents trust that their manufacturers have properly identified the grades of each chemical and ensured that the chemicals have met all regulatory and compliance standards for their intended use. It is imperative that everyone in the custody supply chain know and understand the different grades of reagents and chemicals and their uses, which are explained in this article.
When making a solution, the manufacturer must first decide what degree of chemical purity is needed based on the intended use. The following list describes the seven most common grades of reagents and chemicals, from highest to lowest grade/purity:
ACS, Reagent, and USP-NF grades are typically equivalent and interchangeable but, even so, appropriateness should always be confirmed before application. This can be done by reviewing the applicable regulatory requirements.
Lab, purified, and technical grades of reagents and chemicals have their own uses. For example, lab-grade chemicals, because of their low cost and good chemical purity, are used widely in educational applications, such as teaching laboratories at both the secondary school and college levels; however, lab-grade chemicals would not be appropriate for use in the quality control laboratory of a pharmaceutical or medical device manufacturer. ACS-, USP-, or reagent-grade chemicals should be applied in this setting, because they have fewer impurities that could ultimately impact patients taking the drugs made with those chemicals.
With seven different and inequivalent grades of reagents and chemicals, it is crucial to understand how they can impact products. Using a lower-purity grade than a product’s intended use requires could be a costly mistake. Similarly, using a higher-purity grade when not required could result in unnecessary costs. Add in the increased regulatory scrutiny and it becomes even more important to have a complete understanding of the components that your process requires.
LR grade chemicals refer to chemicals that meet the specifications outlined by the Laboratory Reagent (LR) grade. LR grade chemicals are often used in laboratory settings for analytical and research purposes. These chemicals are of high purity, with impurities specified and controlled to ensure accuracy and reliability in experimental work.
AR grade chemicals, also known as Analytical Reagent grade chemicals, are chemicals that meet the specifications outlined for analytical applications in laboratories. These chemicals are of high purity, typically exceeding 95 percent, with impurities specified and controlled to ensure accuracy and reliability in analytical procedures. AR grade chemicals are suitable for a wide range of analytical techniques, including titrations, spectrophotometry, chromatography, and other analytical methods. They are often used in research, quality control, and educational laboratories where precise and consistent results are essential.
The most acceptable chemical grade depends on the specific requirements of the intended application. However, in many cases, the highest purity grade available is preferred to ensure the accuracy, reproducibility, and reliability of results. For most laboratory analytical work, the highest grades such as ACS (American Chemical Society) grade, AR (Analytical Reagent) grade, or equivalent are typically considered the most acceptable. These grades offer the highest level of purity.
