Description

Goserelin Ep Impurity G ((D-His2)-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 certified reference standard for analytical method development, validation, and quality control. It is essential for manufacturers and analytical laboratories in the pharmaceutical industry who require high-purity impurities to ensure the safety, efficacy, and regulatory compliance of Goserelin-based drug products.

Application

• Primary use as a certified reference standard for the identification and quantification of Goserelin Ep Impurity G in drug substances and products.
• Critical component in analytical method development and validation (HPLC, LC-MS) for Goserelin purity and stability studies.
• Essential material for pharmaceutical quality control (QC) and quality assurance (QA) laboratories to meet ICH guidelines.
• Used in stability-indicating studies to monitor degradation pathways of Goserelin under various stress conditions.
• Valuable for regulatory submissions (e.g., ANDA, NDA) to establish impurity profiles and specifications.
• Supports research and development of Goserelin generics and related peptide therapeutics.

Basic Information

Product Name	Goserelin Ep Impurity G ((D-His2)-Goserelin)
CAS No.	1926163-37-2
Molecular Formula	C59H84N18O14
Molecular Weight	1269.4 g/mol
Synonyms	(D-His2)-Goserelin; Goserelin Related Compound G; Goserelin Impurity G; Goserelin EP Impurity G; (5-Oxo-Pro-His-Trp-Ser-Tyr-D-His-Leu-Arg-Pro-Azgly-NH2); LHRH Agonist Impurity; Gonadorelin Analog Impurity; Azaglycine-Goserelin Impurity
EINECS	Contact for details

Quality Control

Our Goserelin Ep Impurity G is manufactured under strict quality systems suitable for use as a reference standard. Each batch undergoes comprehensive analytical characterization, including HPLC for purity, MS for structural confirmation, and NMR for identity verification. A detailed Certificate of Analysis (COA) is provided, which includes batch-specific data, chromatograms, and storage recommendations. Our quality commitment aligns with the standards expected for pharmaceutical impurities and reference materials.

Storage

Preserve in a tightly closed container, protected from light. Store at -20°C or below. This product is hygroscopic (moisture-sensitive). Allow the vial to equilibrate to room temperature in a desiccator before opening to prevent condensation and moisture uptake. For long-term storage, keep desiccated at -20°C.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Consistent with molecular weight
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 2.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%

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