Description

Lixisenatide Acetate CAS NO 1997361-87-1 is a synthetic glucagon-like peptide-1 (GLP-1) receptor agonist, formulated as the acetate salt for enhanced stability and pharmaceutical processing. This high-purity active pharmaceutical ingredient (API) is critical for the development and commercial manufacturing of advanced type 2 diabetes therapeutics. It is primarily required by pharmaceutical companies, biotechnology research firms, and contract development and manufacturing organizations (CDMOs) engaged in metabolic disorder treatments.

Application

• Pharmaceutical API: Primary active ingredient in the formulation of injectable GLP-1 agonist therapies for type 2 diabetes management.
• Drug Development: Used in preclinical and clinical research for developing next-generation anti-diabetic and weight management drugs.
• Formulation Studies: Essential for stability testing, excipient compatibility studies, and dosage form development (e.g., lyophilized powders, solutions).
• Reference Standard: Serves as a high-purity analytical standard for quality control (QC) and regulatory compliance testing (HPLC, MS).
• Biosimilar Development: Key component in the development and characterization of biosimilar versions of GLP-1 based medications.
• Combination Therapies: Investigated for use in fixed-dose combination products with other anti-diabetic agents like insulin.

Basic Information

Product Name	Lixisenatide Acetate
CAS No.	1997361-87-1
Molecular Formula	C215H347N61O66 • xC2H4O2
Molecular Weight	~4858.4 g/mol (free base)
Synonyms	Lixisenatide acetate salt; AVE0010 acetate; GLP-1 (7-37) Lys26-(N-ε-(γ-Glu(N-α-hexadecanoyl)))-Arg34 acetate; Lyxumia (brand name) API; Z10 acetate; GLP-1 agonist acetate; Glucagon-like peptide-1 analog acetate
EINECS	Contact for details

Quality Control

Our Lixisenatide Acetate is manufactured under strict quality management systems in compliance with cGMP (current Good Manufacturing Practice) guidelines for active pharmaceutical ingredients (APIs). Each batch undergoes comprehensive analytical testing, including HPLC for purity and assay, peptide mapping, related substances profiling, residual solvent analysis, and tests for bioburden and endotoxins. A comprehensive Certificate of Analysis (COA) documenting full compliance with agreed specifications is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or refrigerated (2-8°C) as specified for the specific grade. Due to its hygroscopic (moisture-sensitive) nature, the container must be kept in a dry environment and sealed immediately after use to prevent moisture uptake.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC/MS)	Conforms to reference standard
Assay (HPLC)	≥ 98.0% (on anhydrous basis)
Purity (HPLC)	≥ 97.0% (Total related substances ≤ 3.0%)
Water Content (KF)	≤ 8.0%
Acetic Acid Content	4.0% - 12.0%
Peptide Content	≥ 80.0%
Acetate Counterion (IC)	Conforms
Bacterial Endotoxins	< 10 EU/mg
Bioburden	≤ 100 CFU/g

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