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Measurement of Residual Solvents in a Drug Substance by a Purge-And-Trap Method

Measurement of Residual Solvents in a Drug Substance by a Purge-And-Trap Method

Miklós Lakatos

J Pharm Biomed Anal. 2008 Aug 5;47(4-5):954-7.

PMID: 18436411

Abstract:

The purge-and-trap (P&T) gas extraction method combined with gas chromatography was studied for its suitability for quantitative residual solvents determination in a water-soluble active pharmaceutical ingredient (API). Some analytical method performance characteristics were investigated, namely, the repeatability, the accuracy and the detection limit of determination. The results show that the P&T technique is--as expected--more sensitive than the static headspace, thus it can be used for the determination of residual solvents pertaining to the ICH Class 1 group. It was found that it could be an alternative sample preparation method besides the static headspace (HS) method.

Chemicals Related in the Paper:

Catalog Number	Product Name	Structure	CAS Number	Price
IAR42144	Residual Solvents Class 1 PT			Price

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