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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.
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.
Methanol or Acetonitrile are the solvents used for analyzing many impurities in Clomiphene.
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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