Description

Triptorelin Impurity 5 is a specified impurity of the synthetic decapeptide Triptorelin, a gonadotropin-releasing hormone (GnRH) agonist. This compound is critical for pharmaceutical research and development, serving as a key reference standard for the analytical characterization and quality control of Triptorelin active pharmaceutical ingredients (APIs) and finished drug products. It is primarily utilized by pharmaceutical manufacturers, contract research organizations (CROs), and analytical laboratories engaged in method development, stability studies, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of Triptorelin Impurity 5 in drug substances and products.
• Analytical Method Development & Validation: Essential for developing and validating stability-indicating HPLC, UPLC, or LC-MS methods for Triptorelin.
• Quality Control & Batch Release: Employed in routine QC testing to ensure Triptorelin API and formulations meet stringent purity specifications per ICH guidelines.
• Stability Studies: Used to monitor the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Supports regulatory filings (e.g., for FDA, EMA) by providing necessary impurity profiling and characterization data.
• Process Chemistry Research: Aids in the optimization of Triptorelin synthesis by identifying and controlling impurity formation during manufacturing.

Basic Information

Product Name	Triptorelin Impurity 5
CAS No.	78969-57-0
Molecular Formula	C₆₄H₈₂N₁₈O₁₂
Molecular Weight	1311.5 g/mol
Synonyms	5-D-Tryptophan-Triptorelin; Triptorelin Related Compound 5; Triptorelin EP Impurity D; Triptorelin USP Impurity 5; [5-D-Trp]-Triptorelin; Decapeptide D-Trp-6 impurity; Gonadorelin (6-D-Trp) analog impurity; PGL-1
EINECS	Contact for details

Quality Control

Every batch of Triptorelin Impurity 5 is manufactured and controlled under a strict quality management system. The product undergoes comprehensive analytical testing, including HPLC purity determination, chiral purity verification, and structural confirmation (MS, NMR), to ensure identity, potency, and consistency. Our quality standards align with ICH Q3A/B guidelines for impurities in new drug substances and products. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

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 must be kept in a dry environment. For long-term storage, consider desiccation and storage under inert atmosphere.

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)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C

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