Dabigatran - NDSRI's
References
FAQ's
References
- Hauel, Norbert; Ries, Uwe; Priepke, Henning; Wienen, Wolfgang; Stassen, Jean Marie, Disubstituted Bicyclic Heterocycles, Their Production And Use As Medicaments, Boehringer Ingelheim Pharma K.-G., Germany, EP966454B1, May 7, 2003
- Delavenne, Xavier; Moracchini, Julie; Laporte, Silvy; Mismetti, Patrick; Basset, Thierry, UPLC MS/MS assay for routine quantification of dabigatran - a direct thrombin inhibitor - in human plasma, Journal of Pharmaceutical and Biomedical Analysis, Volume: 58, Pages: 152-156, 2012
Frequently Asked Questions
What are the potential risks associated with uncontrolled Dabigatran impurities?
Uncontrolled impurities in Dabigatran may pose risks such as reduced drug potency, increased toxicity, or harm to patients.
How are impurity limits determined for Dabigatran?
Impurity limits for Dabigatran are typically determined based on scientific and regulatory considerations and factors such as toxicological studies and stability data.
Can Dabigatran impurities impact its stability?
Some impurities in Dabigatran can affect its stability over time, leading to decreased shelf life or reduced potency.
What are the temperature conditions required to store Dabigatran impurities?
Dabigatran impurities are stored at a controlled room temperature between 2-8 °C or as indicated on the Certificate of Analysis (CoA).
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