Description

Tolterodin Hydrogen Tartrate is the hydrogen tartrate salt form of tolterodine, a competitive muscarinic receptor antagonist. This specific salt form is crucial for enhancing the stability and bioavailability of the active pharmaceutical ingredient (API). It is primarily used in the pharmaceutical industry for the manufacture of finished dosage forms targeting overactive bladder (OAB) syndrome. Our supply ensures high purity and consistent quality for critical drug development and production processes.

Application

• Pharmaceutical API Intermediate: Key starting material or intermediate in the synthesis of tolterodine-based medications.
• Finished Dosage Form Manufacturing: Direct compression or granulation for the production of extended-release tablets and capsules.
• Generic Drug Development: Sourcing of a high-quality reference standard and bulk active material for ANDA submissions.
• Clinical Trial Material (CTM) Supply: Provision of GMP-grade material for Phase I-III clinical studies.
• Research & Development: Used in preclinical and pharmacological studies for new urinary antispasmodic formulations.
• Contract Manufacturing: Reliable supply for CDMOs (Contract Development and Manufacturing Organizations) producing antimuscarinic drugs.

Basic Information

Product Name	Tolterodin Hydrogen Tartrate
CAS No.	209747-05-7
Molecular Formula	C26H37NO8
Molecular Weight	491.58 g/mol
Synonyms	Tolterodine Hydrogen Tartrate; Tolterodine L-Tartrate; (R)-Tolterodine Hydrogen Tartrate; (R)-2-[3-(Diisopropylamino)-1-phenylpropyl]-4-methylphenol Hydrogen Tartrate; Detrol (brand name salt form); PNU-200583; (R)-N,N-Diisopropyl-3-(2-hydroxy-5-methylphenyl)-3-phenylpropylamine L-Hydrogen Tartrate
EINECS	Contact for details

Quality Control

Our Tolterodin Hydrogen Tartrate is manufactured and tested under a strict quality management system. We provide material that meets or exceeds relevant pharmacopeial standards, including USP/EP monographs where applicable. Every batch is supported by a comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profiles, ensuring full traceability and compliance for GMP-driven applications.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This compound is hygroscopic (moisture-sensitive); therefore, the container must be kept tightly sealed in a low-humidity environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time matches reference
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 1.5%
Specific Rotation	+22.0° to +26.0° (c=1 in H2O)

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