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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
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