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- W2068155550 abstract "Purpose: Counterfeit drug products have become a major problem worldwide and a number of techniques to detect counterfeit products or reduce the potential for counterfeiting have been investigated. This study examined the use of stable isotope-labeled excipients in solid dosage forms as a method to identify drug products and to detect counterfeits. Methods: 2H- and 13C-glucose were used as model excipients and incorporated in wet granulated formulations at a variety of different isotopic ratios. The ratios of 2H/1H and 13C/12C in each product were then determined by isotope ratio mass spectrometry. Results: Results demonstrated the ability to detect the isotope-labeled glucose in both granules and tablets. Conclusions: It was possible to use the isotope ratios to differentiate between specific batches of granules, demonstrating the potential of this technique for in-product, batch-specific identification." @default.
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- W2068155550 date "2010-06-19" @default.
- W2068155550 modified "2023-10-10" @default.
- W2068155550 title "Stable isotope-labeled excipients for drug product identification and counterfeit detection" @default.
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- W2068155550 doi "https://doi.org/10.3109/03639045.2010.492397" @default.
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