Description

Batefenterol Succinate CAS NO 945905-37-3 is a high-purity pharmaceutical salt form of the long-acting muscarinic antagonist (LAMA) and long-acting beta2-adrenergic agonist (LABA) dual-pharmacology molecule, batefenterol. This compound is critical for the development of novel respiratory therapeutics, offering a synergistic mechanism of action for improved bronchodilation. It is primarily utilized by pharmaceutical R&D teams and manufacturers focused on next-generation treatments for chronic obstructive pulmonary disease (COPD) and asthma.

Application

• Pharmaceutical Active Ingredient (API): Serves as the key active pharmaceutical ingredient in the formulation of innovative respiratory medications.
• Clinical Research & Development: Used in preclinical and clinical studies to evaluate the efficacy, safety, and pharmacokinetics of dual-action bronchodilators.
• Dry Powder Inhaler (DPI) Formulations: A critical component in the development of stable, high-performance dry powder formulations for inhalation therapy.
• Reference Standard: Employed as a certified reference standard for analytical method development, validation, and quality control testing in regulatory submissions.
• Mechanistic Studies: Utilized in pharmacological research to investigate the dual M3 receptor antagonism and β2-adrenoceptor agonism in respiratory smooth muscle.

Basic Information

Product Name	Batefenterol Succinate
CAS No.	945905-37-3
Molecular Formula	C29H36N4O8
Molecular Weight	568.62 g/mol
Synonyms	Batefenterol Hemisuccinate; (R)-Batefenterol Succinate; GSK-961081 Succinate; TD-5959; (R)-3-[(1-{2-[(3-{[(2,2-Difluoro-2-phenylethyl)amino]methyl}phenyl)amino]-2-methylpropyl}piperidin-4-yl)oxy]propyl 2-hydroxy-2,2-diphenylacetate succinate
EINECS	Contact for details

Quality Control

Our Batefenterol Succinate is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing to ensure identity, purity, and consistency, meeting the stringent requirements for pharmaceutical development. Specifications are aligned with ICH guidelines. A detailed Certificate of Analysis (COA) is provided with each shipment, documenting results for assay, related substances, residual solvents, and other critical parameters.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. This material 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 (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥98.0% (on anhydrous basis)
Related Substances (HPLC)	Total impurities ≤2.0%; Any single impurity ≤0.5%
Water Content (KF)	≤1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Heavy Metals	≤20 ppm

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