Description

Goserelin Ep Impurity L ((D-Leu7)-Goserelin) is a specified impurity of the active pharmaceutical ingredient Goserelin, a synthetic decapeptide analog of luteinizing hormone-releasing hormone (LHRH). This compound is critical for pharmaceutical research and development, serving as a key reference standard in the analytical characterization and quality control of Goserelin drug substances and products. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure product purity, safety, and compliance with stringent pharmacopeial standards such as the European Pharmacopoeia (EP).

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Goserelin Ep Impurity L in drug substance and finished product analysis.
• Method Development and Validation: Essential for developing, optimizing, and validating analytical methods, particularly High-Performance Liquid Chromatography (HPLC) and Liquid Chromatography-Mass Spectrometry (LC-MS) methods.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing to monitor impurity profiles and ensure Goserelin products meet specifications for EP, USP, or ICH guidelines.
• Stability Studies: Used to track the formation of this specific degradation product under various stress conditions to establish product shelf-life.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., CMC sections of IND, NDA, ANDA) to demonstrate thorough impurity characterization and control.
• Research on Degradation Pathways: Aids in understanding the chemical and physical degradation mechanisms of the Goserelin peptide.

Basic Information

Product Name	Goserelin Ep Impurity L ((D-Leu7)-Goserelin)
CAS No.	1926163-38-3
Molecular Formula	C59H84N18O14
Molecular Weight	1269.4 g/mol
Synonyms	(D-Leu7)-Goserelin; Goserelin Impurity L; Goserelin Related Compound L; Goserelin EP Impurity L; Ac-D-2-Nal-D-4-Cl-Phe-D-3-Pal-Ser-Tyr-D-Leu-Leu-Arg-Pro-Azagly-NH2; [D-Leucine7]-Goserelin; LHRH analog impurity
EINECS	Contact for details

Quality Control

Every batch of Goserelin Ep Impurity L is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced techniques like HPLC and LC-MS to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, related substances, residual solvents, and other critical parameters.

Storage

Preserve in a tightly closed container, protected from light. Store at -20°C or below in a dedicated freezer. This product is hygroscopic (moisture-sensitive). Allow the sealed vial to equilibrate to room temperature before opening to minimize moisture uptake. For long-term storage, consider under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Mass spectrum conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0%
Assay (on anhydrous basis)	95.0% - 105.0%

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