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DEVELOPMENT AND VALIDATION OF THE GAS CHROMATOGRAPHIC METHODS FOR THE DETERMINATION OF ORGANIC VOLATILE IMPURITIES IN TRAVOPROST AND ITS STARTING MATERIAL

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Groman A., Mariola M., Stolarczyk E.
Acta Poloniae Pharmaceutica - Drug Research
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2020
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vol. 77
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issue 1
23-33
EN
The methods for controlling organic volatile impurities, including residual solvents and reagents, in the travoprost active pharmaceutical ingredient, has been reported. Monitoring the chemical purity of the starting material - TV-38A ((R)-(-)-2-(tert-Butyldimethylsilyloxy)-3-(3-trifluoromethylphenoxy)propan-1-ol) – is critical, as it may directly affect the impurity profile and the quality of the final product. The proposed methods have been developed using gas chromatography as well as gas chromatography with headspace injection and they have been validated according to the requirements of the ICH (International Conference of Harmonization) Q2R1 validation guidelines and the Q3C guideline for residual solvents.
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PURITY DETERMINATION OF THE STARTING MATERIALS USED IN THE SYNTHESIS OF PHARMACEUTICAL SUBSTANCES

100%
Groman A., Stolarczyk E., Mucha M.
Acta Poloniae Pharmaceutica - Drug Research
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2019
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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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