Description

Leuprorelin EP Impurity C is a specified impurity of the active pharmaceutical ingredient Leuprorelin, a synthetic nonapeptide analog of gonadotropin-releasing hormone (GnRH). This compound is critical for pharmaceutical quality control and regulatory compliance, serving as a reference standard for analytical testing. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions involved in the development, production, and quality assurance of Leuprorelin acetate drug products and related formulations.

Application

• Primary use as a pharmaceutical reference standard for the identification and quantification of impurities in Leuprorelin acetate bulk drug and finished dosage forms.
• Essential component in analytical method development and validation (e.g., HPLC, UPLC) for compliance with pharmacopeial monographs (EP, USP).
• Used in stability studies and forced degradation studies to understand the degradation pathways of Leuprorelin.
• Critical for regulatory submissions (e.g., ANDA, NDA) to demonstrate comprehensive impurity profiling and control strategies.
• Supports in-house quality control testing in GMP manufacturing environments to ensure batch-to-batch consistency and purity.
• Valuable for academic and clinical research investigating the pharmacology and metabolism of GnRH analogs.

Basic Information

Product Name	Leuprorelin EP Impurity C
CAS No.	54785-87-4
Molecular Formula	C59H84N16O12
Molecular Weight	1209.4 g/mol
Synonyms	Leuprorelin Related Compound C; Leuprolide Impurity C; 5-Oxo-D-prolyl-L-histidyl-L-tryptophyl-L-seryl-L-tyrosyl-D-leucyl-L-leucyl-L-arginyl-N-ethyl-L-prolinamide; Des-Gly10, D-Leu6, Pro9-NHEt GnRH; Leuprorelin Acetate Impurity C; Leuprolide Acetate Impurity C; EP Impurity C of Leuprorelin
EINECS	Contact for details

Quality Control

Our Leuprorelin EP Impurity C is manufactured and controlled under a strict quality management system. Each batch is characterized and tested using advanced analytical techniques including HPLC, MS, and NMR to ensure identity, purity, and consistency. We provide comprehensive Certificates of Analysis (COA) with detailed chromatographic and spectroscopic data, supporting its use as a high-quality reference standard for pharmacopeial (EP/USP) compliance and GMP applications.

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. Due to its hygroscopic (moisture-sensitive) nature, the container must be kept in a dry environment. For long-term storage, consider desiccants or inert atmosphere to maintain stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Conforms to reference standard
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 95.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Meets ICH guidelines
Specific Rotation	Contact for details

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