Description

Buserelin Ep Impurity D is a specified impurity of the synthetic peptide hormone Buserelin, a Gonadotropin-Releasing Hormone (GnRH) agonist. This compound is critical for pharmaceutical research and development, serving as a reference standard for analytical method development, validation, and quality control processes. It is primarily utilized by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure the purity, safety, and efficacy of Buserelin-based drug substances and products.

Application

• As a pharmaceutical reference standard for the identification and quantification of Buserelin Ep Impurity D in active pharmaceutical ingredients (APIs).
• For analytical method development and validation (e.g., HPLC, UPLC, LC-MS) in quality control laboratories.
• In stability studies and impurity profiling to monitor degradation pathways of Buserelin formulations.
• To support regulatory submissions (e.g., for FDA, EMA) by providing characterized impurity samples.
• For use in pharmacopeial testing to comply with EP, USP, or other international monographs.
• In research and development of Buserelin analogs and related peptide therapeutics.

Basic Information

Product Name	Buserelin Ep Impurity D
CAS No.	88699-82-5
Molecular Formula	C₆₀H₈₆N₁₆O₁₃
Molecular Weight	1239.4 g/mol
Synonyms	Buserelin Related Compound D; Des-Gly-NH₂(10), D-Ser(tBu)⁶, Azagly¹⁰-NH₂ LHRH; Pyr-His-Trp-Ser-Tyr-D-Ser(tBu)-Leu-Arg-Pro-Azagly-NH₂; Buserelin Impurity D; LHRH (6-10) Agonist Impurity; Gonadorelin (6-10) Analog Impurity; [Des-Gly¹⁰, D-Ser(tBu)⁶, Pro⁹-NHEt] LHRH Impurity D
EINECS	Contact for details

Quality Control

Our Buserelin Ep Impurity D is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity determination, mass spectrometry (MS) for identity confirmation, and residual solvent analysis, to ensure it meets high-purity standards suitable for use as a reference material. Certificates of Analysis (COA) with detailed chromatographic data are provided to support your GMP and regulatory compliance needs.

Storage

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

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 unspecified impurity ≤ 1.0%
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.