Description

Lixisenatide CAS NO 320367-13-3 is a synthetic glucagon-like peptide-1 (GLP-1) receptor agonist, a critical active pharmaceutical ingredient (API) in the treatment of type 2 diabetes. Its primary value lies in its ability to enhance glucose-dependent insulin secretion, suppress glucagon release, and slow gastric emptying, offering a targeted therapeutic approach. This high-purity peptide is essential for pharmaceutical manufacturers engaged in the research, development, and commercial production of next-generation injectable antidiabetic medications.

Application

• Pharmaceutical API: Primary active ingredient in the formulation of injectable GLP-1 agonist therapies for glycemic control in type 2 diabetes.
• Drug Development & Research: Used in preclinical and clinical research to study the efficacy and mechanisms of incretin-based therapies.
• Biosimilar Development: A key reference compound for companies developing biosimilar versions of established GLP-1 receptor agonist drugs.
• Combination Therapy Research: Investigated in combination with other antidiabetic agents like insulin or metformin for enhanced therapeutic regimens.
• Analytical Standard: Serves as a high-purity reference standard in quality control laboratories for HPLC, LC-MS, and other analytical methods.

Basic Information

Item	Details
Product Name	Lixisenatide
CAS No.	320367-13-3
Molecular Formula	C215H347N61O65S
Molecular Weight	4858.4 g/mol
Synonyms	AVE0010; ZP10; Lyxumia (brand name); GLP-1 (7-37) Lys26-(Nε-(γ-Glu(Nα-hexadecanoyl)))-Arg34; Lixisenatide acetate; Glucagon-like peptide-1 agonist; Incretin mimetic
EINECS	Contact for details

Quality Control

Our Lixisenatide is manufactured under strict quality management systems. Each batch is subjected to comprehensive analytical testing, including HPLC for purity and assay, peptide mapping, and residual solvent analysis, to ensure it meets stringent pharmaceutical-grade specifications. Certificates of Analysis (COA) detailing all test results are provided and can be tailored to support regulatory filings for GMP compliance.

Storage

Preserve in a tightly closed container, protected from light. Store at -20°C or below for long-term stability. This product is hygroscopic (moisture-sensitive). Allow the sealed vial to equilibrate to room temperature before opening to minimize condensation and moisture uptake.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC/MS)	Conforms to reference standard
Purity (HPLC)	≥ 98.0%
Assay (HPLC)	95.0% - 105.0%
Water Content (KF)	≤ 5.0%
Acetic Acid Content (HPLC)	1.0% - 10.0%
Related Substances (HPLC)	Individual impurity ≤ 1.0%; Total impurities ≤ 2.0%
Bacterial Endotoxins	< 10 EU/mg

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