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

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Groman A., Stolarczyk E., Mucha M.
Acta Poloniae Pharmaceutica - Drug Research
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2019
|
vol. 76
|
issue 1
29-35
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.
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