Sacubitril - NDSRI's
References
FAQ's
References
- Ksander, Gary, Biaryl substituted 4-amino-butyric acid amides, Ciba-Geigy Corp., United States, US5217996A, June 8, 1993
- Patel, C. J.; Mishra, Shweta; Patel, M. M., Simultaneous estimation of sacubitril and valsartan in pharmaceutical dosage form by development and validation of stability indicating chromatographic method, World Journal of Pharmacy and Pharmaceutical Sciences, Volume: 6, Issue: 7, Pages: 1434-1448, 2017
Frequently Asked Questions
What are the challenges associated with detecting and quantifying impurities in Sacubitril?
The challenges associated with detecting and quantifying impurities in Sacubitril include its low level, the complex manufacturing process, and the usage of sensitive and specific analytical techniques. The variability of impurities between different batches of the drug can also be a challenge.
How can Sacubitril impurities affect its stability and shelf life?
The Impurities in Sacubitril affect its stability and shelf life by promoting degradation reactions that reduce the drug’s potency over time. A few impurities also affect the physical properties of the drug, such as its solubility and crystallinity.
Which solvent helps in the analysis of Sacubitril impurities?
Methanol or Acetonitrile is the solvent used in analyzing many impurities in Sacubitril.
What are the temperature conditions required to store Sacubitril impurities?
Sacubitril impurities are stored at a controlled room temperature between 2-8 ⁰C or as indicated on the Certificate of Analysis (CoA).
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