Full-text resources of PSJD and other databases are now available in the new Library of Science.
Visit https://bibliotekanauki.pl

PL EN


Preferences help
enabled [disable] Abstract
Number of results
2019 | 76 | 1 | 29-35

Article title

PURITY DETERMINATION OF THE STARTING MATERIALS USED IN THE SYNTHESIS OF PHARMACEUTICAL SUBSTANCES

Content

Title variants

Languages of publication

EN

Abstracts

EN
High requirements on the API quality mean that the quality control of the starting material is crucial to the manufacturing process of drug substances. Three sensitive methods for the purity determination of the following starting materials: ethylene glycol (method I), 3-acetylpyridine (method II) and 4-chloromethyl-5-methyl-1,3-dioxol-2-one (method III) used in the synthesis of selected drug substances were developed using GC-FID techniques. All the methods were validated according to the International Conference on Harmonization guidelines. The correlation coefficient values were found about 0.99. The obtained RSD values from the replicate injections in the range of 20 - 120% of the nominal concentration ensured the precision.

Year

Volume

76

Issue

1

Pages

29-35

Physical description

Dates

published
2019-02-28

Contributors

References

Document Type

Publication order reference

Identifiers

YADDA identifier

bwmeta1.element.doi-10_32383_appdr_94437
JavaScript is turned off in your web browser. Turn it on to take full advantage of this site, then refresh the page.