Description

Buserelin Ep Impurity C is a specified impurity of Buserelin, a synthetic peptide analog of gonadotropin-releasing hormone (GnRH). This compound is critical for pharmaceutical research and development, serving as a key reference standard in the analytical characterization and quality control of Buserelin drug substances and products. It is primarily required by pharmaceutical manufacturers, contract research organizations (CROs), and analytical laboratories involved in ensuring the purity, safety, and regulatory compliance of peptide-based therapeutics.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Buserelin Ep Impurity C in drug substance and finished product analysis.
• Method Development and Validation: Essential for developing and validating robust analytical methods, such as HPLC and LC-MS, for impurity profiling.
• Quality Control (QC) Testing: Employed in routine QC testing to monitor impurity levels and ensure batch-to-batch consistency of Buserelin API.
• Stability Studies: Used to track the formation of this specific degradation product under various stress conditions, supporting shelf-life determination.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to demonstrate comprehensive impurity control strategies.
• Research on Degradation Pathways: Aids in studying the chemical and physical degradation pathways of Buserelin to improve formulation stability.

Basic Information

Product Name	Buserelin Ep Impurity C
CAS No.	70280-55-6
Molecular Formula	C₆₀H₈₆N₁₆O₁₃
Molecular Weight	1239.4 g/mol
Synonyms	Buserelin Related Compound C; Buserelin EP Impurity C; [D-Ser(tBu)⁶, AzGly¹⁰]-LHRH (1-9) Ethylamide; Pyr-His-Trp-Ser-Tyr-D-Ser(tBu)-Leu-Arg-Pro-Azagly-NH₂; Gonadorelin (6-D-Ser(t-butyl), 10-azaGly) analog; LHRH analog impurity; AzaGly¹⁰ Buserelin
EINECS	Contact for details

Quality Control

Our Buserelin Ep Impurity C is manufactured and controlled under strict quality systems suitable for use as a reference standard. Each batch undergoes comprehensive analytical testing, including HPLC purity determination, mass spectrometry (MS) for identity confirmation, and residual solvent analysis. We provide a comprehensive Certificate of Analysis (COA) with each shipment, detailing all test results against stringent in-house specifications. Our quality commitment aligns with the standards expected for pharmaceutical impurity standards.

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. This material is hygroscopic (moisture-sensitive). The container must be kept tightly sealed in a dry environment to prevent absorption of moisture. For long-term storage, consider storing under 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%
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.