Description

Leuprorelin EP Impurity E is a specified impurity of the peptide pharmaceutical active ingredient Leuprorelin, used for analytical reference and quality control purposes. This high-purity reference standard is critical for ensuring the safety and efficacy of Leuprorelin-based drug products by enabling accurate identification and quantification during manufacturing. It is an essential material for pharmaceutical R&D laboratories, quality assurance departments, and regulatory compliance teams focused on peptide synthesis and impurity profiling.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of Leuprorelin EP Impurity E in drug substances and products.
• Analytical Method Development & Validation: Critical for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods for impurity analysis.
• Quality Control & Batch Release Testing: Used in pharmaceutical QC labs to monitor impurity levels against ICH Q3A/B guidelines and pharmacopeial specifications (EP, USP).
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Supports the filing of regulatory documents (e.g., CMC sections for FDA, EMA) by providing impurity characterization data.
• Peptide Research & Synthesis Monitoring: Serves as a benchmark in research on Leuprorelin synthesis pathways, purification processes, and degradation mechanisms.

Basic Information

Product Name	Leuprorelin EP Impurity E
CAS No.	1926163-23-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Leuprorelin Impurity E; Leuprolide Impurity E; Leuprorelin Related Compound E; 5-Oxo-D-leucyl-L-histidyl-L-tryptophyl-L-seryl-L-tyrosyl-D-leucyl-L-leucyl-L-arginyl-N-ethyl-L-prolinamide; Leuprorelin Degradation Product; Leuprorelin Process Impurity; Leuprolide EP Impurity E
EINECS	Contact for details

Quality Control

Our Leuprorelin EP Impurity E is manufactured under strict quality management systems. Each batch is characterized and qualified using advanced analytical techniques including HPLC, LC-MS, and NMR to ensure high purity and accurate identification. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for identity, purity, and impurity profile. Our quality standards align with the requirements for pharmaceutical reference materials.

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 must be kept in a dry environment. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (MS)	Mass spectrum consistent with structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Complies with specification
Water Content (KF)	≤ 5.0%

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