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Clomiphene
References
FAQ's
Frequently Asked Questions
How are Clomiphene impurities monitored in the final drug product?
Clomiphene impurities are monitored in the final drug product through routine quality control testing, where samples are analyzed to ensure compliance with regulatory requirements regarding impurity content.
Can Clomiphene impurities harm patients?
Some Clomiphene impurities can harm patients due to reduced drug efficacy, increased toxicity, or unexpected side effects. Therefore, controlling them is crucial for patient safety.
Which solvent helps in the analysis of Clomiphene impurities?
Methanol or Acetonitrile are the solvents used for analyzing many impurities in Clomiphene.
What are the temperature conditions required to store Clomiphene impurities?
Clomiphene impurities are stored at a controlled room temperature between 2-8 °C or as indicated on the Certificate of Analysis (CoA). Highly sensitive Clomiphene impurities such as 4-HydroxyClomiphene (Mixture of Z and E Isomers) are stored in an inert atmosphere.
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