Clomiphene Citrate is a pharmaceutical active ingredient belonging to the selective estrogen receptor modulator (SERM) class. It is the citrate salt of clomiphene and contains a mixture of the E- and Z-geometric isomers. Clomiphene is associated with estrogen-receptor activity and has been used in pharmaceutical formulations for ovulation induction under appropriate medical supervision.
Clomiphene Citrate is identified by CAS Number 50-41-9 and has a molecular weight of 598.08 g/mol. The parent compound clomiphene has CAS 911-45-5 and molecular weight 406.0 g/mol.
The USP specification defines Clomiphene Citrate as containing 98.0%–102.0% of the combined E/Z isomers on an anhydrous basis, with the Z-isomer at 30.0%–50.0%.
Clomiphene Citrate is primarily used in pharmaceutical formulations associated with ovulation induction and fertility treatment. Its use is subject to applicable medical, pharmaceutical and regulatory requirements.
Clomiphene Citrate quality testing can include identification, assay, geometric-isomer content, organic impurities and water determination. The USP 2025 specification lists assay, Z-isomer and impurity acceptance criteria for the material.
Preserve in well-closed containers and store at controlled room temperature, in accordance with the applicable approved specification and safety documentation.
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Identification | Conforms to USP identification tests |
| Assay (HPLC) | 98.0% – 102.0% |
| Individual Impurity | NMT 2.0% for Clomiphene Related Compound A; other specified limits apply |
| Total Impurities | NMT 2.5% |
| Melting Point | About 115°C |