Impurity analysis is not only important for maintaining consistency and product quality. Patient safety and reliability are equally important, if not more so. Lawsuits against pharmaceutical companies have reached epidemic levels over the past decade, and the number of products recalled has increased accordingly. These figures are not only astonishing, but unacceptable and preventable. Safety and effectiveness are the top concerns for pharmaceutical consumers, and companies must make sure that they use the highest level of technology to assure patient safety and satisfaction.

Impurity analysis can be a highly complex and daunting task when working with synthetic pharmaceuticals, but the goal is always to create the purest products possible. Two main factors that affect impurity analysis are quantity and toxicity. Accurate measurements of impurities must be quantifiable in order to detect any levels of toxin in a product that may make it unsafe. Despite careful planning and development, impurities in pharmaceutical products are nearly impossible to avoid. However, the use of spectrophotometers now provides the technology needed to quantify these levels of impurities and avoid hazardous medications from circulating.

Detecting impurities using technology and analysis

There are many steps that occur during the development of synthetic pharmaceuticals that allow impurities to manifest. Throughout each phase of the process, product samples must be used to evaluate and detect even the slightest levels of impurity through color-analysis. These samples are also used to monitor degradation of the final product even after manufacturing is complete.

A variety of tests may be used during the sampling process; however, when trying to analyze tiny molecular particles for possible contaminations, the ratios become very difficult to identify.  Spectrophotometers offer the highest level of technology and are imperative for measuring the extraordinary low-levels of impurities, which can have extremely harmful effects. Chromatographic separation is a necessary process for the detection of these low-levels, making the use spectrophotometers essential for decoding this information and putting it into quantifiable numbers.

Monitoring stability after production

Pharmaceutical drugs can also undergo significant changes after they have passed rigorous testing. Monitoring the shelf-life of a product provides important data, which can help detect impurities in it during the degradation cycle.  Spectrophotometers are continually required to monitor and collect the data needed for product safety. This information needs to be accurate and quantifiable in order to identify any changes that can affect product stability, since even the slightest deviations from standard regulations can have dire consequences.

Close monitoring of samples from the test batch and continuous monitoring of the product until point of sale ensures safety and prevents liability. There are a variety spectrophotometer options available that can accurately measure samples of various shapes, sizes, and consistencies. The quantifiable data that is collected will give the information needed to detect any degradation of the product. From the larger models in manufacturing to the bench-top models for smaller sample monitoring, spectrophotometers are needed from start to finish for impurity analysis of synthetic drugs.

Meeting Consumer Expectations for Safety and Effectiveness

HunterLab specializes in spectrophotometers specifically designed for the pharmaceutical industry. They offer the technology and support necessary to accurately monitor and detect impurities in synthetic drugs. Consumers demand that pharmaceutical companies are trustworthy and provide safe and effective medications on a consistent basis. Contact HunterLab today to find the solution you need to meet these challenges.

Ken Phillips

Mr. Philips has spent the last 30 years in product development and management, technical sales, marketing, and business development in several industries. Today, he is the global market development manager for HunterLab, focused on understanding customer needs, providing appropriate solutions and education, and helping to solve customer color challenges across these industries and cultures.

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