Posted by Ryan Farmer on Fri, Jul 26, 2013 @ 03:51 PM
It is hard to be confident in this world because it is impossible to know everything; therefore, assumptions have to be made. Fortunately, there are checks to minimize the amount of false assumptions, like following ones that have stood the test of time, gathering many opinions from many people, or by following the recommendations from an authoritative body (like the US Pharmacopeia, which the FDA uses for drug purity analyses).
At Beagle Bioproducts, we purify toxins, including microcystin-LR, from cyanobacteria in harmful algal blooms (HABs) to sell to research groups and monitoring agencies. Upon sale of the toxins, we want to be confident that they are at least 95% pure, but that confidence comes with assumptions. There is no written dogma on how to assess the purity of these cyanobacterial toxins, but in the common methodology there are two assumptions…that are actually contradictory.
To help elucidate what those are, I will make an analogy to an apple-selling business. As a business, we want to be confident that the basket of apples that we are selling is actually full of apples, with a small allowance for other things. Since we want to know how much of the basket is apples, we have to separate and measure the apples and the impurities.
The first assumption is that the components in the basket have different characteristics. This is important because everything in this basket is separated by its characteristics like color, shape, flavor, and combinations of such features. One restriction is that you can only see and sort one characteristic at a time, so at the end of three rounds of sorting there is a pile of red, round, and sweet things that you think are only apples. Unfortunately, there is never 100% certainty of the uniformity of that pile because even though apples are red, round, and sweet, pomegranates are also. In contrast to the first assumption regarding different characteristics, the second assumption is that the components in the basket have similar characteristics. This is necessary to quantify how much of the basket is red, round, and sweet. In our line of work it is impossible to actually count each item in each pile, so the entire pile has to be measured at once. If the impurity was one small and heavy lead ingot and each pile’s weight was measured, then the amount of impurities would be overestimated in the pile with the ingot. Likewise, if each pile’s volume was measured, now the impurities would be underestimated in the pile with the ingot.
There is no single solution that can address these assumptions, but at Beagle we compensate for them by using multiple separation techniques, the most widely accepted measurement method (HPLC-PDA), independent 3rd party analysis, and by under-representing our final purity; for we try to get the purity of our microcystin toxin to 100% but then we report it as ≥ 95%, as we explain more thoroughly in this white paper on microcystin purity. It is hard to be confident in this world, but we are confident in our products. How confident? Greater than 95%.
Download a free document on how Beagle determines the identity, purity, and quantity of our microcystin products!