Posted on August 23, 2017
American consumers are more aware than ever when it comes to the ingredients we put into our bodies. Gluten free, peanut free, dairy free, etc.; the list goes on and on. While food packaging clearly labels these ingredients, many consumers overlook these additives in the drugs and medications they take each day. However, the ingredients found in today’s pharmaceuticals are also subject to strict regulations to ensure safety and quality and require accurate analysis to meet industry standards.
Food grade additives are a commonly found in many of the drugs and medications we use on a regular basis. For example, pharmaceutical grade talc and/or starch are often used to create a base for active ingredients and these fillers comprise a large percentage of the product we ingest. Product color and purity are a major concern when it comes to these additives and color standards for pharmaceutical grade starch and talc are necessary to achieve desired results. Color measurement instrumentation is an important tool when it comes to quality control. Spectral analysis provides the information needed to meet industry standards and monitor color changes in formulations.
Measuring Pharmaceutical Starch Quality
Pharmaceutical grade starch is a popular ingredient for use as both a binding agent in hard tablets as well as disintegrating agent in orodispersible formulations. An influx of pharmaceutical grade starch production is inundating the industry as reliable filler for drug use in today’s market. This product is sourced from around the globe and value can vary depending on production quality. One indication of superior quality is in the white appearance of starch, making it a preferred choice of filler for use in color-coded medicationswhere specific color matching is necessary. Though white is classified into one color category, there are many variations within that range. Pure white, or extra-white is the most desirable and marketed as the highest quality product. Measuring pure white relies on spectrophotometric technology, which can differentiate even the slightest variations in hue.
Spectrophotometers measure color value to determine purity by the degree of whiteness. Pure white can be quantified numerically depending on the color scale being used. This means that if there are any impurities in the starch, they will affect its color and be measured as a different color value. color scale data can then be stored and used to develop a pass/fail tolerance.
The ability to monitor changes in color values allows pharmaceutical companies to create color standards for pharmaceutical grade starch and select only the highest quality products for drug formulation. Monitoring color standards by degree of whiteness is an efficient and effective method for evaluating pharmaceutical grade starch and ensuring color quality in product formulations.
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