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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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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