Citrato di enclomifene
| Nome del prodotto | Citrato di enclomifene |
|---|---|
| Numero CAS | 7599-79-3 |
| Altri nomi | trans-Clomiphene citrate; (E)-Clomiphene citrate; 2-[4-[(E)-2-chloro-1,2-diphenylethenyl]phenoxy]-N,N-diethylethanamine citrate |
| Formula molecolare | C26H28ClNO·C6H8O7 |
| Peso molecolare | 598.1 g/mol (citrate salt) |
| Aspetto | Polvere cristallina di colore da bianco a bianco sporco |
| Analisi (HPLC) | ≥98.0% (anhydrous basis) |
| Perdita per essiccazione | ≤0.5% |
| Residuo di combustione | ≤0.1% |
| Metalli pesanti | ≤10 ppm |
| Solubilità | Sparingly soluble in water, freely soluble in ethanol, methanol |
| Confezione | 25 kg fiber drum with double polyethylene liner |
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Sinonimi: 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.
| Parametro | Specifiche |
|---|---|
| Analisi (HPLC) | ≥98.0% |
| Identificazione | IR, HPLC retention time conforms to standard |
| Cis-isomer | ≤0.5% |
| Perdita per essiccazione | ≤0.5% |
| Residuo di combustione | ≤0.1% |
| Metalli pesanti | ≤10 ppm |
| Limiti microbiologici | Conta aerobica totale ≤ 1000 UFC/g; lieviti e muffe ≤ 100 UFC/g; assenza di E. coli |
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