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Cyclophosphamide
References
FAQ's
References
- Dr. Chetan Chavan, Chanakya Thaker, Chetan Chaudhari, Quantification of Cyclophosphamide Impurities in Cyclophosphamide Drug Substance and formulations by Ion chromatography, International Journal of Science and Research (IJSR), Volume 10 Issue 4, April 2021, (DOI: 10.21275/SR21405111749)
- Zon, Gerald; Ludeman, Susan Marie; Egan, William, High-resolution nuclear magnetic resonance investigations of the chemical stability of cyclophosphamide and related phosphoramidic compounds, Journal of the American Chemical Society, Volume: 99, Issue: 17, Pages: 5785-95, 1977
Frequently Asked Questions
How are degradation impurities formed in Cyclophosphamide?
Cyclophosphamide can undergo degradation and form impurities when exposed to various stress conditions, such as acid or base hydrolysis, oxidation, and heat.
What can be the role of a UV detector in the analysis of Cyclophosphamide impurities?
Cyclophosphamide has a characteristic UV absorption spectrum, which allows it to be detected and quantified using a UV detector. The concentration of Cyclophosphamide and its impurities are determined by comparing the UV absorption of the sample to that of known standards.
How do Cyclophosphamide impurities affect the quality of the drug?
The impurities can affect the quality of Cyclophosphamide by reducing its potency, altering its pharmacokinetics or pharmacodynamics, causing unwanted side effects, or even posing a risk to patient safety.
What is the regulatory framework for the control of Cyclophosphamide impurities?
The control of Cyclophosphamide impurities is regulated by various international regulatory bodies such as the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) and the US Food and Drug Administration (FDA).
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