Description

Ganirelix is a synthetic decapeptide and a potent gonadotropin-releasing hormone (GnRH) antagonist. This compound is critical for the controlled inhibition of premature luteinizing hormone (LH) surges in assisted reproductive technology (ART). It is an essential pharmaceutical active ingredient primarily required by manufacturers of fertility drugs and advanced hormone therapies for use in in vitro fertilization (IVF) protocols.

Application

• Primary Active Pharmaceutical Ingredient (API) in injectable fertility medications.
• Key component in controlled ovarian stimulation protocols for In Vitro Fertilization (IVF) and Intracytoplasmic Sperm Injection (ICSI).
• Used to prevent premature ovulation by competitively blocking pituitary GnRH receptors.
• Manufacturing of pre-filled syringes and multi-dose vials for clinical administration.
• Research and development of novel hormone-dependent therapies and diagnostic agents.
• Reference standard in pharmaceutical quality control and bioanalytical laboratories.

Basic Information

Product Name	Ganirelix
CAS No.	124904-93-4
Molecular Formula	C₈₀H₁₀₃ClN₁₈O₁₃
Molecular Weight	1570.2 g/mol
Synonyms	Ganirelix Acetate; Antagon; N-Acetyl-3-(2-naphthyl)-D-alanyl-4-chloro-D-phenylalanyl-3-(3-pyridyl)-D-alanyl-L-seryl-N6-(N-methyl-L-tyrosyl)-D-lysyl-N6-(N-methyl-L-tyrosyl)-L-lysyl-L-isoleucyl-N6-(N-methyl-L-tyrosyl)-L-lysyl-L-prolyl-D-alaninamide; Azaline B; S-26306; GnRH Antagonist (Ganirelix); [Ac-D-2Nal1, D-4Cpa2, D-3Pal3, D-hArg(Et2)6, L-hArg(Et2)8, D-Ala10]-GnRH
EINECS	Contact for details

Quality Control

Our Ganirelix is manufactured under strict cGMP conditions, targeting purity levels suitable for pharmaceutical API use. Quality is assured through a comprehensive battery of tests including HPLC for assay and related substances, residual solvent analysis, and stringent microbiological controls. Certificates of Analysis (COA) detailing full compliance with in-house pharmacopeial-style specifications are provided with each batch.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and must be kept under dry, inert conditions to maintain stability and potency.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Conforms to reference standard
Identification (IR)	Conforms to structure
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Meets ICH Q3C guidelines
Bacterial Endotoxins	< 10.0 EU/mg
Microbial Enumeration	Meets Ph. Eur. 2.6.12/2.6.13

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.