Description

Trospium Chloride is a quaternary ammonium antimuscarinic agent, primarily recognized for its therapeutic role in managing overactive bladder (OAB) syndrome. Its value lies in its high selectivity for muscarinic receptors in the bladder, offering effective relief from urinary urgency and frequency with a favorable systemic side-effect profile. This active pharmaceutical ingredient (API) is essential for pharmaceutical manufacturers developing and producing prescription medications for urological disorders. Global demand is driven by the need for reliable, high-purity API suppliers who ensure consistent quality and regulatory compliance.

Application

• Pharmaceutical API: Primary use as the active ingredient in prescription medications for the treatment of overactive bladder (OAB) symptoms, including urinary urgency, frequency, and incontinence.
• Formulation Development: Used in R&D and production of various solid oral dosage forms, most commonly extended-release tablets and capsules.
• Generic Drug Manufacturing: A critical component for companies producing bioequivalent generic versions of branded trospium chloride medications.
• Clinical Trial Materials: Supplied as a reference standard or bulk API for preclinical and clinical research studies investigating urological treatments.
• Veterinary Pharmaceuticals: Potential application in veterinary medicine for managing urinary incontinence in animals, subject to formulation and regulatory approval.

Basic Information

Product Name	Trospium Chloride
CAS No.	10405-02-4
Molecular Formula	C25H30ClNO3 • HCl
Molecular Weight	472.88 g/mol (for the dihydrochloride salt)
Synonyms	Trospium Chloride Dihydrochloride; Spasmex; Spasmo Urgenin; (1R,3r,5S)-3-[(2S)-3-Hydroxy-2-phenylpropanoyl]oxy-8,8-dimethyl-8-azoniabicyclo[3.2.1]octane chloride hydrochloride; Trospium HCl; Trospium Dichloride; Trosponium Chloride; UNII-1E668KP1YS
EINECS	233-874-9

Quality Control

Our Trospium Chloride is manufactured under strict quality management systems. Each batch is tested to ensure it meets stringent specifications for identity, purity, potency, and impurity profiles, aligning with major pharmacopoeial standards such as USP and EP. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results for assay, related substances, residual solvents, heavy metals, and microbiological attributes. We support our partners with full regulatory documentation for drug master files (DMF) as required.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry, and well-ventilated area at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed to protect from moisture. Keep away from incompatible materials.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 1.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Microbiological Enumeration	Complies with EP/USP for non-sterile substances

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