Description

Leuprorelin Ep Impurity F is a specified impurity associated with the active pharmaceutical ingredient Leuprorelin Acetate, a synthetic nonapeptide analog of GnRH. This compound is critical for pharmaceutical research and development, serving as a certified reference standard for analytical method development, validation, and quality control processes. It is primarily utilized by analytical chemists, quality assurance professionals, and researchers in the pharmaceutical and biotechnology industries to ensure the purity, safety, and efficacy of Leuprorelin-based drug products and formulations.

Application

• Pharmaceutical Reference Standard: Serves as a primary standard for the identification and quantification of Leuprorelin Ep Impurity F in drug substances and finished products.
• Analytical Method Development & Validation (HPLC/LC-MS): Essential for developing and validating precise chromatographic methods to monitor impurity profiles.
• Quality Control & Batch Release Testing: Used in routine QC laboratories to ensure drug substance and product compliance with stringent pharmacopeial specifications (e.g., EP, USP).
• Stability Studies & Degradation Pathway Analysis: Employed to study the degradation behavior of Leuprorelin under various stress conditions (e.g., heat, light, pH).
• Regulatory Submissions: Provides critical data for regulatory filings (e.g., FDA, EMA) to demonstrate thorough impurity characterization and control.
• Process Chemistry & Optimization: Aids in monitoring and minimizing the formation of this impurity during the synthesis and purification of Leuprorelin.

Basic Information

Item	Details
Product Name	Leuprorelin Ep Impurity F
CAS No.	1872435-00-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Leuprorelin EP Impurity F; Leuprorelin Related Compound F; Leuprolide EP Impurity F; Leuprorelin Impurity F; Leuprolide Impurity F; Leuprorelin Acetate Impurity F; 5-Oxo-D-prolyl-L-histidyl-L-tryptophyl-L-seryl-L-tyrosyl-D-leucyl-L-leucyl-L-arginyl-N-ethyl-L-prolinamide; A specified degradation product of Leuprorelin.
EINECS	Contact for details

Quality Control

Every batch of Leuprorelin Ep Impurity F is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity analysis, and impurity profiling using advanced techniques such as HPLC and mass spectrometry to ensure they meet the exacting standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results.

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) 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 conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Complies with specification
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH guidelines

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