Description

Glycopyrronium Bromide is a quaternary ammonium anticholinergic agent with significant pharmacological activity. This compound is valued for its potent and selective inhibition of muscarinic acetylcholine receptors, offering therapeutic benefits with a favorable side-effect profile. It serves as a critical active pharmaceutical ingredient (API) for manufacturers in the pharmaceutical industry, particularly for formulating treatments targeting excessive secretions and hyperhidrosis. Global demand is driven by its application in both injectable and topical medicinal products.

Application

• Primary Active Pharmaceutical Ingredient (API) for anticholinergic injectable formulations.
• Key component in topical preparations for the treatment of severe primary axillary hyperhidrosis (excessive sweating).
• Used in the synthesis of advanced drug delivery systems and prodrugs.
• Research and development of new therapeutic agents targeting muscarinic receptors.
• Reference standard for analytical testing and quality control in pharmaceutical laboratories.
• Potential use in veterinary medicine for controlling secretions.

Basic Information

Product Name	Glycopyrronium Bromide
CAS No.	475468-09-8
Molecular Formula	C19H28BrNO3
Molecular Weight	398.34 g/mol
Synonyms	Glycopyrrolate Bromide; Glycopyrronium Bromide; 3-[(Cyclopentylhydroxyphenylacetyl)oxy]-1,1-dimethylpyrrolidinium Bromide; Nuvig; Robinul; Seebri; (3RS)-3-{[(2RS)-Cyclopentyl(2-hydroxyphenyl)acetyl]oxy}-1,1-dimethylpyrrolidin-1-ium Bromide; 1-Methyl-3-pyrrolidyl α-cyclopentylmandelate Methobromide
EINECS	Contact for details

Quality Control

Our Glycopyrronium Bromide is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing to ensure it meets high-purity standards suitable for pharmaceutical use. Certificates of Analysis (COA) are provided, detailing parameters such as assay, related substances, residual solvents, and identification. We support compliance with ICH guidelines, USP/EP monographs where applicable, and relevant GMP standards.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere conditions.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms
Identification (HPLC)	Conforms
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 5.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Heavy Metals	≤ 20 ppm
Sulfated Ash	≤ 0.1%

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