Description

Teduglutide Impurity 1 (iso-Asp3) is a specified impurity of the active pharmaceutical ingredient Teduglutide, a glucagon-like peptide-2 (GLP-2) analog. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development, validation, and quality control of Teduglutide drug substance and products. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure product safety, purity, and compliance with stringent pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of the iso-Asp3 impurity in Teduglutide API and finished drug products.
• Analytical Method Development: Essential for developing and optimizing chromatographic methods (e.g., HPLC, UPLC) to separate and accurately measure process-related impurities.
• Quality Control & Stability Studies: Employed in routine batch release testing and long-term stability studies to monitor impurity profiles and ensure product consistency over its shelf life.
• Regulatory Compliance & Filings: Supports the preparation of regulatory documentation (e.g., CMC sections for FDA, EMA) by providing necessary impurity characterization data.
• Process Chemistry Research: Aids in understanding and controlling the formation of this specific degradation product during the synthesis, purification, and formulation of Teduglutide.

Basic Information

Product Name	Teduglutide Impurity 1 (iso-Asp3)
CAS No.	864513-54-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Isoaspartyl-3-Teduglutide; Teduglutide Related Compound A; Teduglutide iso-Asp3 Impurity; GLP-2 (1-33) (human) iso-Asp3; H-Gly-His-Ala-Glu-Gly-Thr-Phe-Ile-Ser-Asp-Tyr-Ser-Ile-Ala-Met-Asp-Lys-Ile-His-Gln-Gln-Asp-Phe-Ile-Asn-Trp-Leu-Ile-Gln-Thr-Lys-Ile-Thr-Asp (isoAsp3); Teduglutide Degradant
EINECS	Contact for details

Quality Control

Our Teduglutide Impurity 1 (iso-Asp3) is manufactured under controlled conditions and undergoes rigorous analytical characterization to ensure high purity and identity. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results from advanced techniques such as HPLC, MS, and NMR. We adhere to ICH Q3B(R2) guidelines for impurities in new drug substances, ensuring our reference standards meet the exacting requirements of pharmaceutical development and regulatory compliance.

Storage

Preserve in a tightly closed container, protected from light. Store at -20°C or below. This product is hygroscopic (moisture-sensitive). Allow the vial to equilibrate to room temperature in a desiccator before opening to prevent moisture absorption.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0%

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