Dapagliflozin - Isotope Labelled Standards
References
FAQ's
References
- Ellsworth, Bruce; Washburn, William N.; Sher, Philip M.; Wu, Gang; Meng, Wei, C-Aryl Glucoside SGLT2 Inhibitors, Bristol-Myers Squibb Company, United States, EP1224195B1, May 18, 2005
- Sanagapati, Manasa; Dhanalakshmi, K.; Nagarjunareddy, G.; Sreenivasa, S., Development and validation of a RP-HPLC method for the estimation of dapagliflozin in API, International Journal of Pharmaceutical Sciences and Research, Volume: 5, Issue: 12, Pages: 5394-5397, 2014
Frequently Asked Questions
Is the control of genotoxic impurities a critical concern in Dapagliflozin?
Yes, the control of genotoxic impurities is of utmost importance in Dapagliflozin due to its potentially harmful effects on DNA and increased risk of cancer. There are stringent limits set for genotoxic impurities.
Are there specific guidelines or regulations for the control of Dapagliflozin impurities?
Regulatory authorities such as the FDA and EMA provide guidelines and regulations regarding controlling impurities in Dapagliflozin, ensuring compliance with quality standards.
Which solvent help in the analysis of Dapagliflozin impurities?
Acetonitrile is a solvent used for analyzing many impurities in Dapagliflozin.
What are the temperature conditions required to store Dapagliflozin impurities?
Dapagliflozin 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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