Clomifene Citrate API
Clomifene Citrate is a pharmaceutical active ingredient belonging to the selective estrogen receptor modulator (SERM) class. It is also known as Clomiphene Citrate and is supplied as a citrate salt of clomifene. The compound is widely recognized for its pharmacological activity related to estrogen receptors and is used in pharmaceutical formulations under appropriate medical supervision.
Swapproop provides Clomifene Citrate API for pharmaceutical and research applications, with product information covering identification, quality characteristics, specifications, and applicable standards.
Clomifene Citrate is a crystalline pharmaceutical substance with the molecular formula C26H28ClNO · C6H8O7 and molecular weight 598.08 g/mol. Its CAS number is 50-41-9. The material is the citrate salt of clomifene and consists of a mixture of its geometric isomers.
Clomifene Citrate is primarily associated with pharmaceutical formulations involving ovulatory stimulation. It should be handled and used according to applicable pharmaceutical, regulatory, and safety requirements.
Clomifene Citrate specifications may include identification, assay, related substances, water content and other quality attributes. USP defines Clomiphene Citrate as containing 98.0%–102.0% of the mixture of its E/Z geometric isomers on an anhydrous basis and specifies 30.0%–50.0% Z-isomer.
Store Clomifene Citrate in a tightly closed container and protect from light and excessive moisture. Follow the manufacturer's approved storage conditions and applicable safety documentation.
| Parameter | Specification |
|---|---|
| Identification | Conforms to USP identification tests |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 0.1% |
| Residue on Ignition | NMT 0.5% |
| Heavy Metals | NMT 20 ppm |
| Individual Impurity | NMT 0.5% |
| Total Impurities | NMT 2.0% |
| Melting Point | About 115°C |