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AN72779: Limit of β-cyclodextrin (Betadex) in Betadex Sulfobutyl Ether Sodium
Description
In this application note, we evaluated the USP monograph method. Betadex was separated on a Dionex IonPac AS11 column followed by PAD detection using the specified 3-potential waveform with a gold conventional working electrode. The method was further evaluated with the 4-potential waveform recommended for carbohydrates and a gold disposable working electrode. In this additional evaluation only the waveform was changed compared to the monograph method. Key performance parameters were evaluated including separation, system suitability, linearity, limits of detection, and precision.| Market: | Pharma |
| Keywords: | USP monograph, HPAE-PAD, USP-NF, cyclodextrin, Dionex ICS-5000+ HPIC system, Dionex ICS-6000 HPIC system, Dionex IonPac AS11 column, 3 potential waveform, 4 potential carbohydrate waveform, betadex, excipient, gold conventional working electrode, gold disposable working electrode, TN 20, TN 70671, TN20, TN70671, AN 72779 |
| Matrix: | Betadex Sulfobutyl ether sodium |
| Author: | Manali Aggrawal, Jeff Rohrer |
| Affiliation: | Thermo Fisher Scientific, Sunnyvale, CA USA |
For Research Use Only. Not for use in diagnostic procedures.
