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

• Authors: Aleksandra Groman , Mucha Mariola , Elżbieta Stolarczyk
• Languages of publication: EN

Abstracts

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.

Keywords

EN

validation; residual solvents; GC method; GC-HS method; travoprost; organic volatile impurities

• Journal: Acta Poloniae Pharmaceutica - Drug Research
• Year: 2020
• Volume: 77
• Issue: 1
• Pages: 23-33

Dates

published

2020-02-29

Contributors

author

Aleksandra Groman

author

Mucha Mariola

author

Elżbieta Stolarczyk

Identifiers

DOI

10.32383/appdr/115517