Description

Taltirelin Impurity 2 is a designated impurity reference standard used in the analytical profiling and quality control of Taltirelin, a synthetic thyrotropin-releasing hormone (TRH) analog. This compound is critical for ensuring the purity, safety, and efficacy of Taltirelin in pharmaceutical development and manufacturing. It is primarily required by research institutions, analytical laboratories, and pharmaceutical companies involved in the synthesis, regulatory submission, and batch release of Taltirelin-based drug substances and products.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for qualitative and quantitative analysis in Taltirelin drug substance and product testing.
• Method Development and Validation: Used to develop, optimize, and validate analytical methods (e.g., HPLC, UPLC) for impurity detection and separation.
• Quality Control & Assurance (QC/QA): Employed as a system suitability and identification marker in routine batch analysis to monitor impurity levels against ICH guidelines.
• Stability Studies: Acts as a marker compound to track degradation pathways and assess the stability profile of Taltirelin formulations under various conditions.
• Regulatory Compliance: Essential for preparing documentation for regulatory filings (e.g., FDA, EMA) to demonstrate comprehensive impurity control strategies.
• Research and Development: Utilized in synthetic chemistry research to understand and control the formation of this specific impurity during the manufacturing process.

Basic Information

Product Name	Taltirelin Impurity 2
CAS No.	124916-92-3
Molecular Formula	C17H22N6O4
Molecular Weight	374.40 g/mol
Synonyms	L-Pyroglutamyl-L-histidyl-L-prolinamide impurity; Taltirelin Related Compound; (S)-5-Oxo-1-((S)-1-((S)-2-amino-1-oxopropan-2-yl)-1H-imidazol-4-yl)methyl)pyrrolidine-2-carboxamide; Taltirelin Degradant; Taltirelin Process Impurity; TRH Analog Impurity; CG-3703 Impurity
EINECS	Contact for details

Quality Control

Every batch of Taltirelin Impurity 2 is manufactured and controlled under a strict quality management system. The product undergoes rigorous identity confirmation, purity analysis, and impurity profiling using advanced techniques such as HPLC, MS, and NMR to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment, supporting compliance with ICH Q3A/B and cGMP guidelines where applicable.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container should be kept in a desiccated environment to prevent moisture absorption, which could affect stability and analytical performance. For long-term storage, consider storing under inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%

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