Have you ever wondered exactly what is put into all those pills and capsules that are sitting in your medicine cabinet? Looking at the packaging you will see a list of ‘active ingredients’… but what is all that other stuff? The majority of medication fillers are made from pharmaceutical grade talc, which must pass color value testing to ensure purity and safety. Spectrophotometers measure degree of whiteness in talc to express its color value and ensure that we are not accidently consuming ingredients that are contaminated or harmful.
Making the grade
Medication today is often color-coded for safety reasons, but the internal ingredients still consist mainly of pharmaceutical grade talc. In order for talc to be utilized for human consumption it must pass strict testing in order to meet industry regulation standards. Any failure to pass inspection along the way can mean rejection of an entire batch, a costly incident for any company. This pass or fail system is strictly enforced by the U.S. Pharmacopeial (USP), making accurate color measurement essential at every stage of product development.
The standards for talc purity relate directly to its chemical make-up and levels of unwanted elements that may be present. To reach pharmaceutical grade level, there is minimal tolerance for impurities. Color value is measured through the use of spectrophotometers and determines purity by the degree of whiteness. Chemically pure talc is always white in color, but color value changes are difficult to detect using only visual analysis because the human eye cannot distinguish these slight variations in color.
Spectrophotometers measure the color value in talc by detecting color variations which represent chemical impurities. Pure white only reflects color, so if there are other elements present they are always represented by a separate color value. These measurements must be accurate in order to obtain reliable readings that would qualify talc as eligible for pharmaceutical grade and medical production.
In its purest form, talc provides an optimum resource for pharmaceutical applications. This natural mineral is readily available and its soft texture not only makes it easy to use, but also provides the lubricant necessary for oral medications. Variations in talc naturally exist throughout various parts of the world, but due to the whiteness of its pure form, it can easily be evaluated for other contaminants. Studies have been conducted using both chemical and physiochemical testing for impurities. However, these studies have determined that spectrophotometers and a color value measurement system provide the most accurate results for meeting color parameters guidelines.
The ability to measure color value using spectrophotometers allows pharmaceutical companies to accurately detect levels of impurities in talc and other white materials intend for medical purposes and eliminates restriction for use due to errors. This saves both time and money, and allows production to operate smoothly. Measuring color value by degree of whiteness is the most cost effective method for evaluating pharmaceutical grade talc and meeting the regulations for health and safety.
Choosing the right instrumentation is an important step in meeting these guidelines and finding a company that specializes in industry standards and offers exceptional customer relationship and support is imperative. HunterLab is committed to excellence and works with their clients to find the most effective mode in color value measurement to meet each individual need. Contact HunterLab today to let us share our knowledge and experience with you.