Identifying the Structure of an Unknown Impurity in a Topical Gel

It is not uncommon for pharmaceutical analytical chemists to observe unknown impurities during routine drug product testing using general chromatographic methods such as high-pressure liquid chromatography/ultraviolet or gas chromatography/flame ionization detection. Discovery of an unknown impurity...

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Bibliographic Details
Published inPharmaceutical technology Europe Vol. 32; no. 4; pp. 20 - 24
Main Authors Neal, Jerry, Mizell, Jerry, Durham, Richard, Casteen, Matt
Format Journal Article
LanguageEnglish
Published Monmouth Junction Intellisphere, LLC 01.04.2020
MultiMedia Healthcare Inc
Subjects
Case studies
Chromatography
Experiments
Fourier transforms
Ionization
Ions
Manufacturing
Mass spectrometry
Pharmaceutical industry
Physical instruments
Product testing
Scientific imaging
United States > US
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Summary:It is not uncommon for pharmaceutical analytical chemists to observe unknown impurities during routine drug product testing using general chromatographic methods such as high-pressure liquid chromatography/ultraviolet or gas chromatography/flame ionization detection. Discovery of an unknown impurity triggers an investigation, along with a shift in priorities from routine to more specific specialized testing in order to be able to answer key questions about the impurity. This case study highlights analytical instrumentation and techniques that were used to identify an unknown impurity detected during routine release testing of a topical gel drug product.
ISSN:1753-7967