General Information

Leuprolide Impurities and Leuprolide 

Daicel Pharma synthesizes high-quality Leuprolide impurities, (O Acetyl L Ser) Leuprolide, Ac(2-9) Leuprolide, D His Leuprolide, D Leu Leuprolide, D Ser Leuprolide, D Trp Leuprolide, Des-Ser(4)-Leuprolide, Leuprolide Metabolite(pentapeptide), and more, that help in the quality, stability, and biological safety analysis of Leuprolide. We also offer custom synthesis of Leuprolide impurities and supply worldwide.

Leuprolide [CAS: 53714-56-0] is a synthetic nonapeptide agonist analog of Luteinizing hormone-releasing factor¹. It mimics the natural hormone known as gonadotropin-releasing hormone (GnRH). Leuprolide is a powerful GnRH receptor agonist, commonly prescribed in the treatment of prostate cancer, uterine leiomyomata, endometriosis, and central precocious puberty.

Leuprolide: Use and Commercial Availability 

Leuprolide is prescribed for advanced prostate cancer and is used for pediatric patients with central precocious puberty (CPP). It is also prescribed in combination with iron supplements for preoperative hematological improvement in anemic patients with uterine leiomyomata (also known as uterine fibroids). Additionally, it is used in combination with oral norethisterone (also called norethindrone) in the initial treatment of endometriosis symptoms.

Leuprolide is available as Leuprolide acetate, which is administrable through an intramuscular or subcutaneous injection or as an implant. It is available under several brand names, such as Lupron, Eligard, Viadur, and Leuprorelin.

Leuprolide Structure and Mechanism of Action

The chemical formula for Leuprolide is C₅₉H₈₄N₁₆O₁₂, and its molecular weight is approximately 1,209.40 g/mol.

Leuprolide acetate suppresses the gonadotrope secretion of Luteinizing hormone (LH) and Follicle-Stimulating hormone (FSH) inhibiting gonadal sex steroid production.

Leuprolide Impurities and Synthesis

Leuprolide impurities may form during the synthesis process² or storage of the drug. Deamidated Leuprolide, Leuprolide dimer, Leuprolide oxidation products, Leuprolide-related compounds, and residual solvents are some of the most common Leuprolide impurities affecting the efficacy and stability of the drug. Also, these impurities have toxic and immunogenic effects on the patients. Hence, the manufacturers need to perform rigorous analytical testing to detect and quantify these impurities to ensure the quality and safety of Leuprolide.

At Daicel, we provide a Certificate of Analysis (CoA) from a cGMP-compliant analytical facility for more than fifteen Leuprolide impurity standards such as (O Acetyl L Ser) Leuprolide, Ac(2-9) Leuprolide, D His Leuprolide, D Leu Leuprolide, D Ser Leuprolide, D Trp Leuprolide, Des-Ser(4)-Leuprolide, Leuprolide Metabolite(pentapeptide), and more, along with complete characterization data including 1H NMR, 13C NMR, IR, MASS, and HPLC³ purity. Upon request, we provide 13C-DEPT and CHN. Also, we provide a complete characterization report upon delivery. Daicel offers Leuprolide D10 (labelled), which is a deuterium-labeled standard of Leuprolide in bioanalytical research and BA/BE studies with isotope data in CoA.