Description

Ganirelix Impurity 2 is a specified impurity of Ganirelix Acetate, a synthetic decapeptide used as a gonadotropin-releasing hormone (GnRH) antagonist. This compound is critical for pharmaceutical research and development, serving as a key reference standard in the analytical characterization and quality control of the active pharmaceutical ingredient (API). It is essential for manufacturers and analytical laboratories in the pharmaceutical industry who require high-purity chemical standards to ensure drug safety, efficacy, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Ganirelix Acetate impurities.
• Analytical Method Development & Validation: Critical for developing and validating HPLC, UPLC, or LC-MS methods to monitor impurity profiles in API batches.
• Quality Control & Assurance (QC/QA): Used in routine quality control testing to ensure Ganirelix drug substance and drug products meet stringent pharmacopeial (e.g., USP, EP) specifications.
• Stability Studies: Employed to track the formation of degradation products under various stress conditions (e.g., heat, light, humidity) during drug stability testing.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to demonstrate thorough understanding and control of the API's impurity profile.
• Process Chemistry Research: Aids in optimizing synthesis and purification processes to minimize the formation of this specific impurity.

Basic Information

Product Name	Ganirelix Impurity 2
CAS No.	2135326-92-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Ganirelix Related Compound 2; Ganirelix Acetate Impurity 2; Ganirelix EP Impurity B; Ganirelix USP Impurity 2; Antide Impurity; GnRH Antagonist Impurity; (2S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-Amino-3-(1H-imidazol-5-yl)propanoyl]amino]-3-(4-hydroxyphenyl)propanoyl]amino]-3-hydroxypropanoyl]amino]-3-phenylpropanoyl]amino]-3-(1H-indol-3-yl)propanoyl]amino]-4-methylpentanoyl]amino]-3-(1H-imidazol-5-yl)propanoyl]amino]-3-(4-hydroxyphenyl)propanoyl]amino]-5-(diaminomethylideneamino)pentanoic acid
EINECS	Contact for details

Quality Control

Our Ganirelix Impurity 2 is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including advanced chromatographic techniques, to ensure identity, purity, and consistency. We provide comprehensive Certificates of Analysis (COA) with detailed chromatographic data, supporting its use as a pharmaceutical reference standard. Specifications are designed to meet the needs of pharmacopeial (USP/EP) impurity qualification.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. The product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Mass spectrum consistent with structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 2.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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