Description

Semaglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist, representing a significant advancement in metabolic disease management. This compound is valued for its potent and long-acting effects, offering superior glycemic control and weight management benefits. It is a critical active pharmaceutical ingredient (API) primarily required by pharmaceutical manufacturers and research institutions developing next-generation treatments for type 2 diabetes and obesity.

Application

• Pharmaceutical API: Primary use as the active ingredient in injectable medications for the treatment of type 2 diabetes mellitus.
• Obesity Management: Key component in formulations approved for chronic weight management in adults with obesity or overweight with weight-related comorbidities.
• Cardiovascular Risk Reduction: Used in drug products indicated to reduce the risk of major cardiovascular events in patients with type 2 diabetes and established cardiovascular disease.
• Clinical Research: Serves as a reference standard and investigational material in preclinical and clinical studies for metabolic disorders.
• Drug Development: Utilized in formulation R&D for developing new delivery systems, including oral tablets and sustained-release injectables.
• Biosimilar & Generic Development: Essential for companies developing biosimilar or generic versions of branded semaglutide products.

Basic Information

Product Name	Semaglutide
CAS No.	910463-68-2
Molecular Formula	C187H291N45O59
Molecular Weight	4113.6 g/mol
Synonyms	Semaglutide; NN9535; NNC 0113-0217; Ozempic® API; Rybelsus® API; Wegovy® API; GLP-1 (7-37) analog; Glucagon-like peptide-1 receptor agonist
EINECS	Contact for details

Quality Control

Our Semaglutide is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing to ensure it meets stringent specifications for identity, purity, potency, and related substances. We provide full traceability and support regulatory filings with comprehensive documentation, including detailed Certificates of Analysis (COA). Our quality standards align with ICH guidelines and current Good Manufacturing Practices (cGMP) for active pharmaceutical ingredients.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature or under refrigeration (2-8°C) as specified for the specific salt form. This product is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Conforms to reference standard
Identification (MS)	Conforms
Assay (HPLC)	≥ 98.0%
Purity (Related Substances)	Total impurities ≤ 2.0%
Single Unknown Impurity	≤ 0.5%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Meets ICH Q3C limits
Bacterial Endotoxins	< 10 EU/mg
Microbial Enumeration	Meets Ph. Eur. 2.6.12/2.6.13

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