Enclomiphene citrate
| Product Name | Enclomiphene citrate |
|---|---|
| CAS Number | 7599-79-3 |
| Other Names | trans-Clomiphene citrate; (E)-Clomiphene citrate; 2-[4-[(E)-2-chloro-1,2-diphenylethenyl]phenoxy]-N,N-diethylethanamine citrate |
| Molecular Formula | C26H28ClNO·C6H8O7 |
| Molecular Weight | 598.1 g/mol (citrate salt) |
| Appearance | White to off-white crystalline powder |
| Assay (HPLC) | ≥98.0% (anhydrous basis) |
| Loss on Drying | ≤0.5% |
| Residue on Ignition | ≤0.1% |
| Heavy Metals | ≤10 ppm |
| Solubility | Sparingly soluble in water, freely soluble in ethanol, methanol |
| Package | 25 kg fiber drum with double polyethylene liner |
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Synonyms: trans-Clomiphene citrate, (E)-Clomiphene citrate, Enclomiphene dihydrogen citrate, 2-[4-[(E)-2-chloro-1,2-diphenylethenyl]phenoxy]-N,N-diethylethanamine citrate
Enclomiphene citrate is the trans-isomer of clomiphene citrate, a selective estrogen receptor modulator (SERM) that has drawn considerable attention in both clinical research and pharmaceutical manufacturing. Unlike its cis counterpart zuclomiphene, which exhibits estrogenic activity, enclomiphene acts as a pure estrogen antagonist in the hypothalamus and pituitary. This distinct pharmacological profile has positioned it as a compound of interest for developing therapies targeting testosterone deficiency and related endocrine disorders.
Chemically, enclomiphene citrate belongs to the triphenylethylene class, sharing structural similarities with tamoxifen and other well-known SERMs. The molecule features a chloro-substituted stilbene core with a diethylaminoethoxy side chain, and its citrate salt form enhances aqueous solubility and stability. The trans configuration is critical for its antagonistic properties; even minor contamination with the cis isomer can significantly alter the pharmacological response, making stereochemical purity a key quality parameter.
In the pharmaceutical supply chain, enclomiphene citrate is typically produced under cGMP conditions and is available in high-purity grades suitable for formulation development and clinical trial materials. It is most commonly used in the development of oral capsules or tablets for hormone modulation, and as a reference standard in analytical laboratories. Its rising profile in men’s health research has led to increased demand for reliable, well-documented sources of this active pharmaceutical ingredient.
| Parameter | Specification |
|---|---|
| Assay (HPLC) | ≥98.0% |
| Identification | IR, HPLC retention time conforms to standard |
| Cis-isomer | ≤0.5% |
| Loss on Drying | ≤0.5% |
| Residue on Ignition | ≤0.1% |
| Heavy Metals | ≤10 ppm |
| Microbial Limits | Total aerobic count ≤1000 CFU/g; Yeast & Mold ≤100 CFU/g; E. coli absent |
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