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The Analysis of Residual Solvents By Headspace Sampling and GC According to USP <467>

Type: Application

Application Note

Gen. Pharma & Chemistry
Number: Technology

Application Notes #283029

GC-Systems
Year Products

2011

  Author
 

  Reference
 

BDAL07-2011
 

Abstract
 

For pharmacopeial purposes, residual solvents in pharmaceuticals are defined as organic volatile chemicals that are consumed or produced in the manufacture of
drug products.
Appropriate selection of the solvent for the synthesis of a drug substance may enhance the yield, or determine characteristics such as crystal form, purity and solubility. Therefore, the solvent may sometimes be a critical element in the synthetic process. Residual solvents are not completely removed by practical manufacturing techniques.
The United States Pharmacopeia (USP) <467> specifies
the gas chromatographic conditions1 for the analysis of these organic volatile impurities (OVI).
This application note describes the gas chromatographic analysis of these residual solvents combined with the headspace sampling and injection technique.

 
 

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Bruker_App_Note_Sept_2011_283029.pdf
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