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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Published in | Pharmaceutical technology Europe Vol. 32; no. 4; pp. 20 - 24 |
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Main Authors | , , , |
Format | Journal Article |
Language | English |
Published |
Monmouth Junction
Intellisphere, LLC
01.04.2020
MultiMedia Healthcare Inc |
Subjects | |
Online Access | Get full text |
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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. |
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ISSN: | 1753-7967 |