Description

Tolterodine Hydrobromide is the hydrobromide salt form of tolterodine, a potent and competitive muscarinic receptor antagonist. This active pharmaceutical ingredient (API) is critical for the formulation of medications designed to manage overactive bladder (OAB) syndrome, providing relief from symptoms such as urinary urgency, frequency, and incontinence. It is an essential raw material for global pharmaceutical manufacturers engaged in the production of generic and branded urological therapeutics. Our supply of Tolterodine Hydrobromide CAS NO 837376-36-0 is characterized by stringent quality control, ensuring reliability for critical drug development and production processes.

Application

This high-purity pharmaceutical intermediate is utilized in several key areas:

• Primary Pharmaceutical Ingredient: As the active component in finished dosage forms for the treatment of overactive bladder.
• Generic Drug Manufacturing: Serves as a core API for the production of bioequivalent generic versions of antimuscarinic medications.
• Formulation R&D: Used in research and development for creating new extended-release tablets, capsules, and other oral solid dosage forms.
• Clinical Trial Material: Supplied as a qualified ingredient for the manufacture of drugs used in clinical studies and trials.
• Contract Manufacturing: Supplied to CDMOs (Contract Development and Manufacturing Organizations) for commercial-scale production.
• Reference Standard: High-purity grades can be used as analytical reference standards in quality control laboratories.

Basic Information

Product Name	Tolterodine Hydrobromide
CAS No.	837376-36-0
Molecular Formula	C22H31NO • HBr
Molecular Weight	398.40 g/mol
Synonyms	(R)-2-[3-(Diisopropylamino)-1-phenylpropyl]-4-methylphenol hydrobromide; (R)-N,N-Diisopropyl-3-(2-hydroxy-5-methylphenyl)-3-phenylpropylamine hydrobromide; Tolterodine HBr; PNU-200583; Detrol (brand name salt form); Darifenacin related compound (structural analog).
EINECS	Contact for details

Quality Control

Our Tolterodine Hydrobromide is manufactured and tested under strict quality management systems. Each batch is analyzed to meet exacting specifications for identity, purity, and impurity profiles, aligning with ICH guidelines. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results for assay, related substances, residual solvents, and other critical parameters. We support compliance with major pharmacopoeial standards, including USP and EP, and can accommodate custom purity requirements for specific project needs.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry, and well-ventilated place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed after opening to prevent moisture absorption, which can affect stability and handling properties. Keep away from incompatible materials.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 1.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.10% Total impurities: ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
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.