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Determination of residual solvent in pharmaceutical preparations by static headspace GC

✍ Scribed by Penton, Zelda

Publisher
John Wiley and Sons
Year
1992
Tongue
English
Weight
252 KB
Volume
15
Category
Article
ISSN
0935-6304

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✦ Synopsis

Abstract

Static headspace GC, a simple, clean technique which is easily automated, appears to be a good approach to the determination of solvent residues in pharmaceutical preparations. The feasibility of this approach has been studied with an automated system.

Data is presented for the solvents designated as impurities in pharmaceutical preparations by the United States Pharmacopeia. It was found that the static headspace technique meets the United States Pharmacopeia criteria for sensitivity. The absolute area count precision was <5% relative standard deviation and correlation coefficients to a linear response were >0.999. It was concluded that the technique is viable for this application.

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