Description

Exenatide Acetate is a synthetic glucagon-like peptide-1 (GLP-1) receptor agonist, widely recognized for its role in glycemic control. This high-purity active pharmaceutical ingredient (API) is critical for the formulation of long-acting injectable medications for type 2 diabetes management. It is primarily utilized by pharmaceutical manufacturers and research institutions engaged in metabolic disorder therapeutics and advanced peptide drug development.

Application

• Pharmaceutical API: Primary active ingredient in the manufacture of extended-release injectable formulations for type 2 diabetes treatment (e.g., Bydureon®).
• Drug Discovery & Research: Used as a reference standard and biochemical tool in metabolic research, GLP-1 receptor studies, and preclinical investigations.
• Formulation Development: Serves as a key component in the development of novel drug delivery systems, including microsphere and sustained-release technologies.
• Contract Manufacturing: Supplied to CDMOs (Contract Development and Manufacturing Organizations) for the production of finished dosage forms.
• Regulatory Submissions: Provides the necessary quality-grade material for stability studies and regulatory filing dossiers (e.g., ANDA, NDA).

Basic Information

Product Name	Exenatide Acetate
CAS No.	141732-76-5
Molecular Formula	C184H282N50O60S
Molecular Weight	4186.6 g/mol
Synonyms	Exenatide; AC2993; LY2148568; Synthetic Exendin-4; Exenatide Acetate Salt; (1-39)-Exendin-4 Acetate; GLP-1 Receptor Agonist; LAR (Long-Acting Release) Exenatide
EINECS	Contact for details

Quality Control

Our Exenatide Acetate is manufactured under strict quality management systems, ensuring it meets the rigorous standards required for pharmaceutical applications. Each batch is tested for identity, purity, potency, and related substances using validated analytical methods, including HPLC and mass spectrometry. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing compliance with in-house specifications aligned with ICH Q3 and pharmacopeial guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at a controlled temperature of 2°C to 8°C (refrigerated). Due to its hygroscopic nature, the product should be stored in a dry environment. For long-term storage, consider desiccant use within the primary container. Keep away from incompatible materials.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC/MS)	Conforms to reference standard
Assay (HPLC)	≥ 98.0% (on anhydrous basis)
Related Substances (HPLC)	Total impurities ≤ 2.0%
Single Unknown Impurity	≤ 0.5%
Water Content (KF)	≤ 5.0%
Acetate Content (IC)	3.0% - 8.0%
Bacterial Endotoxins	< 10 EU/mg

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