title: Rapid screening of guar gum using portable Raman spectral identification methods.
abstract: Guar gum is a well-known inactive ingredient (excipient) used in a variety of oral pharmaceutical dosage forms as a thickener and stabilizer of suspensions and as a binder of powders. It is also widely used as a food ingredient in which case alternatives with similar properties, including chemically similar gums, are readily available. Recent supply shortages and price fluctuations have caused guar gum to come under increasing scrutiny for possible adulteration by substitution of cheaper alternatives. One way that the U.S. FDA is attempting to screen pharmaceutical ingredients at risk for adulteration or substitution is through field-deployable spectroscopic screening. Here we report a comprehensive approach to evaluate two field-deployable Raman methods--spectral correlation and principal component analysis--to differentiate guar gum from other gums. We report a comparison of the sensitivity of the spectroscopic screening methods with current compendial identification tests. The ability of the spectroscopic methods to perform unambiguous identification of guar gum compared to other gums makes them an enhanced surveillance alternative to the current compendial identification tests, which are largely subjective in nature. Our findings indicate that Raman spectral identification methods perform better than compendial identification methods and are able to distinguish guar gum from other gums with 100% accuracy for samples tested by spectral correlation and principal component analysis.
authors.affiliation: Division of Pharmaceutical Analysis, Center for Drug Evaluation and Research, US Food and Drug Administration, 645 S. Newstead Ave., St. Louis, MO 63110, United States.
authors.forename: Hirsch K
authors.initials: HK
authors.lastname: Srivastava
authors.affiliation: Division of Pharmaceutical Analysis, Center for Drug Evaluation and Research, US Food and Drug Administration, 645 S. Newstead Ave., St. Louis, MO 63110, United States.
authors.forename: Steven
authors.initials: S
authors.lastname: Wolfgang
authors.affiliation: Division of Pharmaceutical Analysis, Center for Drug Evaluation and Research, US Food and Drug Administration, 645 S. Newstead Ave., St. Louis, MO 63110, United States. Electronic address: Jason.Rodriguez@fda.hhs.gov.
authors.forename: Jason D
authors.initials: JD
authors.lastname: Rodriguez
mesh_terms: D004340:Drug Contamination / Q000517:prevention & control; D004353:Drug Evaluation, Preclinical / Q000379:methods / Q000592:standards; D005685:Galactans / Q000032:analysis*; D008351:Mannans / Q000032:analysis*; D053149:Plant Gums / Q000032:analysis*; D013059:Spectrum Analysis, Raman / Q000379:methods* / Q000592:standards; D013997:Time Factors
chemical_list: D005685:Galactans; D008351:Mannans; D053149:Plant Gums; C007894:guar gum
keywords: Economically-motivated adulteration; Identification tests; Rapid screening; Raw ingredients; Spectroscopy