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Efinaconazole
References
FAQ's
References
- Naito, Takanobu; Kobayashi, Haruhito; Ogura, Hironobu; Nagai, Kiyoshi; Nishida, Tokiko; Arika, Tadashi; Yokoo, Mamoru; Nakahashi, Satoko, Azolylamine Derivative, Kaken Pharmaceutical Co., Ltd., Japan, EP698606B1, December 17, 1997
- Patani, Nikesh; Patel, Mrunali ; Patel, Rashmin, Development and validation of HPLC methodology for quantitative estimation of Efinaconazole in topical pharmaceutical formulation prepared in-house for the treatment of onychomycosis, Separation Science plus, Volume: 3, Issue: 9, Pages: 375-383, 2020
Frequently Asked Questions
Are Efinaconazole impurities assessed for their potential toxicity?
Yes, impurities in Efinaconazole undergo comprehensive toxicological evaluations to determine their potential toxicity and establish safe exposure limits. This assessment ensures patient safety during drug administration.
Can Efinaconazole impurities affect its stability over time?
Some impurities in Efinaconazole can impact its stability over time, potentially leading to degradation or reduced shelf life. Stability studies assess the drug's integrity under various storage conditions.
How often are impurity profiles for Efinaconazole reviewed and updated?
Impurity profiles for Efinaconazole are regularly reviewed and updated to align with evolving regulatory guidelines, scientific advancements, and emerging safety concerns. These updates help ensure the drug's continued quality and safety.
What are the temperature conditions required to store Efinaconazole impurities?
Efinaconazole 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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