In chemistry, a buffer is a solution that resists changes in pH. To understand the principle of buffers, it is first important to understand the genesis of the buffer solution, along with concepts and theory behind how buffers work, and how they are utilized in real world applications. Buffers were introduced into the scientific field by the US agronomist, Theodore Clinton Mcllvaine, in 1920, by preparing a buffer pH range of 2.2 to 8 from two chemical stock solutions. These two stocks were prepared by one liter of 0.2M stocks of disodium hydroxyphosphate and one liter of 0.1M stock of citric acid. Mcllvaine understood that combining the two stock substances at varying amounts of each mixture would yield different pK values, that would lead to either an increase, or decrease in pH values.

This simple mixture was expanded upon by increasing the robustness of the original mix, adding more compounds that could extend this pH buffer range. This discovery made by Mcllvaine later became known as Mcllvain’s buffer solution. These “Universal” buffer mixtures are now used in biological applications, as well as analytical testing techniques, providing ways to improve precision and reliability for routine and research testing regimes.

Buffers may exist for various pH ranges. The phosphate buffer serves as a common chemical that is widely used in industry due to its ability to hover at the pH of 7.2. This is a common buffer in most biological processes because it allows the study to emulate biological conditions. This buffer is also a common buffer in process driven reactions, as it ensures that acidic environmental conditions are neutralized before proceeding to the next step in a manufacturing process.

Pharma, clinical and testing laboratory clients that work under regulatory bodies often require more stringent buffer solutions that are standardized and calibrated to NIST, with certified tolerance limits. This is for processes that use pH meters, in-process testing for GMP spaces, and any analytical release data that get reviewed and certified to support external/internal clients. Buffers and reference standards are utilized in this case to ensure reliable and accurate results.

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