We use the word “color consistency” a lot when referring to products that depend on this trait for quality assurance. In the pharmaceutical industry, color consistency means a lot more than the final color outcome of a product. Color consistency in pharmaceutical powders and plaques is essential for developing the right drug formulations and repeating these formulas accurately every time. Although outward appearance and color-coding do have their place in prescription drugs, what consumers and patients are most concerned about is that the active pharmaceutical ingredients will be the precise dosage and formulation they need each time they take a medication. Spectrophotometers measure color consistency to ensure that each powder or plaque formulation attains precisely the correct components for effectiveness and safety.

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Color consistency measurements ensure that the correct formulations of powdered ingredients are achieved before the medication is pressed into tablet form. Image Source: Flickr user Steve Snodgrass

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Measuring Color Consistency with Spectrophotometers

Spectrophotometers use color technology to measure slight variations in pharmaceutical powders and plaques. The determination of color consistency is an important step in the blending process of medications.  “The active pharmaceutical ingredient (API) is often a powder that is blended with other powders (excipients) in order to produce tablets.” When adding the API to the excipient powder, NIR spectrophotometers are used to closely monitor the powder composition and provide a quantitative analysis of the sample. This data shows the levels of color consistency which can then be used to create repeatability from batch to batch. This is extremely important when trying to monitor microscopic amounts of API in powder mixtures which are undetectable through human eye analysis.

Blending is a crucial step in the development of pharmaceuticals and color consistency measurements are essential for creating a product where the API is evenly distributed throughout. This is important for maintaining the right dosages of API in the final product. If errors are made in the blending stages, it can lead to expensive reformulation or recalls further on down the line. Most importantly, improper balances in these ingredients can be dangerous to patients, where under or over-dosage can be disastrous.

Advantages of spectrophotometric analysis

Spectrophotometric analysis is ideal for measuring color consistency in pharmaceutical powders and plaques because it is non-destructive and can be utilized for on-line measurements. This allows for continual monitoring of the product without the need for sample removal, saving both time and money. Once formulations are pressed into plaque form, spectrophotometric instrumentation can be used to measure these samples using specific viewing angles and geometric principles to obtain the most accurate and reliable information. This application can also be used to monitor product stability over time and for quality monitoring as well.

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Various components of powdered pharmaceutical ingredients require quantitative data through color measurement instrumentation for proper formulation and consistent monitoring of active pharmaceutical ingredients (API). Image Source: Flickr user r. nial bradshaw

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HunterLab spectrophotometers are designed for both portability and durability. Our instrumentation has been created to meet the specific needs of the pharmaceutical industry. Our spectrophotometers provide a low-cost alternative to other methods of analysis for blending and compression of pharmaceutical powders and plaques. Our staff is highly knowledgeable in the color measurement of pharmaceutical products and we back our products with unsurpassed customer support. Contact HunterLab to learn more about our pharmaceutical color measurement products today.