Clomiphene (also known as Clomiphene Citrate) is a selective estrogen receptor modulator (SERM) used primarily in the treatment of female infertility. It works by stimulating ovulation through inhibition of estrogen receptors in the hypothalamus, leading to increased release of gonadotropin-releasing hormone (GnRH), luteinizing hormone (LH), and follicle-stimulating hormone (FSH).
Clomiphene is administered orally and is typically prescribed in short cycles.
Indications include:
∙ Ovulatory dysfunction in women (e.g., polycystic ovary syndrome – PCOS)
∙ Off-label: Male infertility, hypogonadism, and secondary testosterone deficiency
Parent: Clomiphene
Parent: Clomiphene
Parent: Clomiphene
Parent: Clomiphene
Parent: Clomiphene
Parent: Clomiphene
Parent: Clomiphene
Parent: Clomiphene
Clomiphene exists as a mixture of isomers (enclomiphene and zuclomiphene), and its impurity profile includes both synthetic by-products and degradation compounds. As it is used chronically and impacts hormone regulation, impurities must comply with ICH Q3A/B and USP/EP standards.
Process-Related Impurities
Degradation Impurities
Elemental Impurities
Analytical Techniques for Impurity Detection
Clomiphene is used to induce ovulation in women with infertility due to ovulatory dysfunction and is also prescribed off-label to treat low testosterone levels in men.
It blocks estrogen receptors in the hypothalamus, increasing GnRH secretion and subsequently stimulating FSH and LH release, which promotes ovulation.
It is typically used for short-term ovulation induction (up to 6 cycles). Prolonged use may increase the risk of ovarian cysts or endometrial thinning.
Clomiphene is generally stable under recommended conditions but should be stored in a cool, dry place, protected from light and moisture to avoid isomerization and degradation.
