title: Quality assessment of internet pharmaceutical products using traditional and non-traditional analytical techniques.
abstract: This work investigated the use of non-traditional analytical methods to evaluate the quality of a variety of pharmaceutical products purchased via internet sites from foreign sources and compared the results with those obtained from conventional quality assurance methods. Traditional analytical techniques employing HPLC for potency, content uniformity, chromatographic purity and drug release profiles were used to evaluate the quality of five selected drug products (fluoxetine hydrochloride, levothyroxine sodium, metformin hydrochloride, phenytoin sodium, and warfarin sodium). Non-traditional techniques, such as near infrared spectroscopy (NIR), NIR imaging and thermogravimetric analysis (TGA), were employed to verify the results and investigate their potential as alternative testing methods. Two of 20 samples failed USP monographs for quality attributes. The additional analytical methods found 11 of 20 samples had different formulations when compared to the U.S. product. Seven of the 20 samples arrived in questionable containers, and 19 of 20 had incomplete labeling. Only 1 of the 20 samples had final packaging similar to the U.S. products. The non-traditional techniques complemented the traditional techniques used and highlighted additional quality issues for the products tested. For example, these methods detected suspect manufacturing issues (such as blending), which were not evident from traditional testing alone.
authors.affiliation: Food and Drug Administration, Division of Pharmaceutical Analysis, 1114 Market Street, St. Louis, MO 63101, USA. westenberger@cder.fda.gov
authors.forename: Benjamin J
authors.initials: BJ
authors.lastname: Westenberger
authors.forename: Christopher D
authors.initials: CD
authors.lastname: Ellison
authors.forename: Andrew S
authors.initials: AS
authors.lastname: Fussner
authors.forename: Susan
authors.initials: S
authors.lastname: Jenney
authors.forename: Richard E
authors.initials: RE
authors.lastname: Kolinski
authors.forename: Terra G
authors.initials: TG
authors.lastname: Lipe
authors.forename: Robbe C
authors.initials: RC
authors.lastname: Lyon
authors.forename: Terry W
authors.initials: TW
authors.lastname: Moore
authors.forename: Larry K
authors.initials: LK
authors.lastname: Revelle
authors.forename: Anjanette P
authors.initials: AP
authors.lastname: Smith
authors.forename: John A
authors.initials: JA
authors.lastname: Spencer
authors.forename: Kimberly D
authors.initials: KD
authors.lastname: Story
authors.forename: Duckhee Y
authors.initials: DY
authors.lastname: Toler
authors.forename: Anna M
authors.initials: AM
authors.lastname: Wokovich
authors.forename: Lucinda F
authors.initials: LF
authors.lastname: Buhse
mesh_terms: D002851:Chromatography, High Pressure Liquid; D004340:Drug Contamination; D004355:Drug Stability; D020407:Internet; D040541:Marketing; D004364:Pharmaceutical Preparations / Q000032:analysis / Q000191:economics / Q000592:standards; D011358:Product Surveillance, Postmarketing; D011786:Quality Control; D012995:Solubility; D019265:Spectroscopy, Near-Infrared; D013818:Thermogravimetry
chemical_list: D004364:Pharmaceutical Preparations