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2020 | 77 | 1 | 23-33
Article title

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

Content
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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.
Year
Volume
77
Issue
1
Pages
23-33
Physical description
Dates
published
2020-02-29
Contributors
References
Document Type
Publication order reference
Identifiers
YADDA identifier
bwmeta1.element.doi-10_32383_appdr_115517
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