Analyzing the Color of Scarce and Expensive Pharmaceutical Materials via Small Sample Testing

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Posted on April 12, 2018

In an ideal world, drug manufacturers could test large batches of any material for color consistency and quality. However, this isn’t a reality for many pharmaceutical companies. Often, the active ingredients that go into a life-saving cancer treatment or a promising new Alzheimer’s medication are expensive to develop, difficult to synthesize, or made from rare, finite natural resources. This means that drug manufacturers have to carefully measure out their test samples, and in some cases, the material is so expensive that they need to be particularly frugal with their sample sizes. For instance, Soliris, a drug used to treat a very rare genetic condition called atypical hemolytic-uremic syndrome, is one of the most expensive medications in the United States—it sells for $18,000 per dose.1 In order to perform quality control tests on an expensive medication like this, manufacturers typically opt for the smallest sample sizes possible to avoid wasting product.

But when your sample size decreases, it can make the color measurement process much more complicated, as many color measurement instruments are incapable of accurately analyzing the color of very small samples; the equipment is typically designed with larger sample sizes in mind, and these one-size-fits-all tools lack the accessories required to measure micro samples. However, there are a number of high-quality spectrophotometric instruments and accessories on the market that are designed specifically to measure small samples with the highest degree of accuracy. When you use one of these instruments in your lab, you can significantly shrink your sample size requirements, helping you preserve valuable materials.

Why Color Consistency Matters

Measuring the color of your pharmaceutical products is important for two primary reasons. First, the color of a drug can help you determine whether there are impurities or contaminants in your sample; if a liquid cough suppressant is supposed to be completely clear, yet your spectrophotometer detects a yellow tint, then it’s possible that your sample was contaminated, or that there is something wrong within your manufacturing line. The second reason color measurement is important is customer perception. Generally, customers are more likely to trust medications that are consistent in color from pill to pill or batch to batch. Additionally, studies have shown that the color of a medication can impact users’ perception of sensory experience and efficacy. The color of medication can even affect whether users adhere to their prescribed medication plans, making color critical to ensuring therapeutic benefit.2 However, when you’re working with scarce or costly medications, the color quality control process can also grow expensive or even compromise medication supply. You have to waste a certain amount of product in order to test for color consistency, and the more expensive your product is, the greater impact your test sample size has on your bottom line and the availability of usable medication.

 

Full article with photos available here:

https://www.hunterlab.com/blog/color-pharmaceuticals/analyzing-the-color-of-scarce-and-expensive-pharmaceutical-materials-via-small-sample-testing/

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