![]() ![]() Patients with prolonged or chronic illnesses may experience exacerbated symptoms or death as a result from taking a counterfeit medication. Examples of counterfeit pharmaceuticals include brand name and generic products in a wide variety of therapeutic groups such as antibiotics, antihistamines, anti-malarials, hormones, steroids, lifestyle drugs, and other products. Combined with Fourier transform infrared (FT-IR) spectroscopy, XRD can be used to differentiate suspect counterfeit products from authentic products.Įstimates vary, but the highest percentages of counterfeit products are often found in developing countries. Previous work has demonstrated that X-ray diffraction is useful in pharmaceutical analysis, including the analysis of suspect counterfeit products (13–15). X-ray powder diffraction (XRD) is a technique used to analyze various types of trace evidence (glass, paint, and drugs ). There are many different counterfeit products (4–7), requiring multiple analytical techniques to authenticate (4,8–10). These illegally manufactured products have been found widely distributed throughout the world, which presents an ongoing public health threat (1–4). Counterfeit pharmaceuticals are unregulated products which may contain dangerous, harmful ingredients, or insufficient amount of the active pharmaceutical ingredients (APIs). The Food and Drug Administration (FDA)’s Forensic Chemistry Center continually investigates new instrumentation and methods to add to the growing list of instrumental techniques available to analyze suspect counterfeit products.Ĭounterfeit pharmaceutical products pose a major threat to public health. It is important to use multidisciplinary approaches when analyzing suspect counterfeit products. Depending on the type of product encountered, a variety of different physical and instrumental analysis techniques may be required to distinguish between a suspect counterfeit and authentic product. Historically, counterfeit products have ranged from poor to very sophisticated copies of the original product. Types of pharmaceutical products counterfeited include solid dosage forms (tablets and capsules) and injectable products (such as oncology drugs). Counterfeit pharmaceuticals are unregulated products that may contain the incorrect amount of active pharmaceutical ingredient (API), a different API, no API, or incorrect excipients within the counterfeit product. As the global marketplace for pharmaceutical products increases, so does the potential for counterfeit products entering the legal distribution supply chain, posing a major threat to public health. ![]()
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