title: Stable isotope-labeled excipients for drug product identification and counterfeit detection.
abstract: OBJECTIVE
  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
  (2)H- and (13)C-glucose were used as model excipients and incorporated in wet granulated formulations at a variety of different isotopic ratios. The ratios of (2)H/(1)H and (13)C/(12)C 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.
authors.affiliation: Department of Pharmaceutical Sciences, College of Pharmacy, University of New Mexico, Albuquerque, NM, USA. lfelton@unm.edu
authors.forename: Linda A
authors.initials: LA
authors.lastname: Felton
authors.forename: Punit P
authors.initials: PP
authors.lastname: Shah
authors.forename: Zachary
authors.initials: Z
authors.lastname: Sharp
authors.forename: Viorel
authors.initials: V
authors.lastname: Atudorei
authors.forename: Graham S
authors.initials: GS
authors.lastname: Timmins
mesh_terms: D002626:Chemistry, Pharmaceutical / Q000379:methods; D058110:Counterfeit Drugs / Q000032:analysis*; D004339:Drug Compounding / Q000379:methods; D005079:Excipients / Q000032:analysis* / Q000737:chemistry*; D007553:Isotope Labeling / Q000379:methods*; D013058:Mass Spectrometry / Q000379:methods; D004364:Pharmaceutical Preparations / Q000032:analysis* / Q000737:chemistry*; D013607:Tablets / Q000032:analysis / Q000737:chemistry
chemical_list: D058110:Counterfeit Drugs; D005079:Excipients; D004364:Pharmaceutical Preparations; D013607:Tablets