Ganirelix is a synthetic gonadotropin-releasing hormone (GnRH) receptor antagonist used in reproductive medicine. It competitively blocks GnRH receptors in the pituitary gland, resulting in rapid suppression of luteinizing hormone (LH) and follicle-stimulating hormone (FSH) secretion.
Ganirelix is commonly supplied as ganirelix acetate, a synthetic decapeptide used during controlled ovarian stimulation to help prevent a premature LH surge.
Ganirelix Acetate is a specialized peptide pharmaceutical ingredient used in assisted reproductive technology and fertility-treatment formulations. It is administered by subcutaneous injection and is generally used during controlled ovarian stimulation protocols.
CAS Number: 124904-93-4
Molecular Formula: C80H113ClN18O13
Molecular Weight: 1570.34 g/mol
Salt Form: Acetate
Drug Class: GnRH Receptor Antagonist
Therapeutic Class: Gonadotropin Suppressant
Therapeutic Area: Reproductive Endocrinology / Fertility
Ganirelix competitively antagonizes GnRH receptors in the anterior pituitary. This prevents GnRH from stimulating the release of LH and FSH. Suppression of LH secretion helps prevent a premature LH surge and premature ovulation during controlled ovarian stimulation.
Ganirelix Acetate is used during controlled ovarian stimulation in assisted reproductive technology, including IVF treatment protocols, to prevent premature LH surges and premature ovulation.
Ganirelix is normally formulated as its acetate salt. As a synthetic peptide GnRH antagonist, Ganirelix Acetate requires specialized peptide synthesis, purification and analytical characterization.
Ganirelix is a synthetic decapeptide containing multiple amino-acid residues and a peptide backbone. It has a molecular formula of C80H113ClN18O13 for the peptide free form and a molecular weight of approximately 1570.34 g/mol. The acetate pharmaceutical salt has a higher molecular mass depending on the number of acetate equivalents and hydration state.
Ganirelix Acetate API quality evaluation may include peptide identity by LC-MS and peptide mapping, purity by RP-HPLC, assay, related peptides, water content, residual solvents, acetate content, elemental impurities and other applicable peptide-specific quality-control tests.
Ganirelix Acetate should be stored under controlled pharmaceutical conditions and protected from excessive heat, moisture and direct light. Because it is a peptide API, storage conditions should be established from validated stability data and the applicable manufacturer specification.
Ganirelix is an important GnRH antagonist in reproductive medicine. Its rapid suppression of pituitary gonadotropin secretion makes it useful for controlling the timing of ovulation during assisted reproductive procedures.
Ganirelix is a synthetic GnRH receptor antagonist supplied pharmaceutically as Ganirelix Acetate. It is identified by CAS Number 124904-93-4, with molecular formula C80H113ClN18O13 and molecular weight 1570.34 g/mol for the peptide free form. It is primarily used in controlled ovarian stimulation protocols to prevent premature LH surges.
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 1.0% |
| Residue on Ignition | NMT 0.5% |
| Heavy Metals | NMT 10 ppm |
| pH (1% Solution) | 5.0 – 7.0 |
| Individual Impurity | NMT 0.5% |
| Total Impurities | NMT 2.0% |
| Water Content | NMT 2.0% |