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Tolterodine Impurities

Tolterodine, sold under brand names like Detrol, is a muscarinic receptor antagonist used primarily to treat overactive bladder (OAB) and associated symptoms such as:
∙ Frequent urination
∙ Urgency
∙ Urge incontinence
It works by blocking muscarinic receptors in the bladder, reducing involuntary muscle contractions and increasing bladder capacity.
Tolterodine is available as immediate-release tablets, extended-release capsules, and sometimes oral solutions.

Structure

Product Name

CAS No.

Cat No.

Action

Desisopropyl Tolterodine Tartrate

Desisopropyl Tolterodine Tartrate

Parent: Tolterodine

CAS No.: N/A

Cat No.: VL460003

Didesisopropyl Tolterodine

Parent: Tolterodine

CAS No.: 1189501-90-3

Cat No.: VL460002

N-Nitroso Tolterodine EP Impurity D

Parent: Tolterodine

CAS No.: N/A

Cat No.: VE0024557

N-Nitroso Tolterodine EP Impurity E

Parent: Tolterodine

CAS No.: 2680528-95-2

Cat No.: VE0024558

rac-N-Nitroso Tolterodine Monoisopropyl 5-Carboxylic Acid

Parent: Tolterodine

CAS No.: N/A

Cat No.: VE0024462

Tolterodine Benzyloxyamine derivative

Parent: Tolterodine

CAS No.: N/A

Cat No.: VE0021196

Tolterodine Dimer

Parent: Tolterodine

CAS No.: 854306-72-2

Cat No.: VL460010

Tolterodine Diol Acetate Impurity

Parent: Tolterodine

CAS No.: 2514856-06-3

Cat No.: VL460009

Tolterodine Diol Impurity

Parent: Tolterodine

CAS No.: 851789-43-0

Cat No.: VL460012

Tolterodine Enantiomer

Parent: Tolterodine

CAS No.: 873551-03-2

Cat No.: VL460001

Tolterodine EP Impurity A

Parent: Tolterodine

CAS No.: 124937-73-1

Cat No.: VL460015

Tolterodine EP Impurity C

Parent: Tolterodine

CAS No.: 124935-88-2

Cat No.: VE006234

Tolterodine EP Impurity C (HCl Salt)

Parent: Tolterodine

CAS No.: 1161940-88-0

Cat No.: VE0025600

Tolterodine EP Impurity D (HCl Salt)

Parent: Tolterodine

CAS No.: N/A

Cat No.: VL460014

Tolterodine EP Impurity E

Parent: Tolterodine

CAS No.: 480432-14-2

Cat No.: VE006248

Tolterodine EP Impurity E (HCl Salt)

Parent: Tolterodine

CAS No.: N/A

Cat No.: VE0025601

Tolterodine EP Impurity G

Parent: Tolterodine

CAS No.: 1554029-91-2

Cat No.: VE006235

Tolterodine for System Suitability CRS (Y0001697)

Parent: Tolterodine

CAS No.: N/A

Cat No.: PVE00291

Tolterodine Lactol

Parent: Tolterodine

CAS No.: 209747-04-6

Cat No.: VL460007

Tolterodine Lactone Impurity

Parent: Tolterodine

CAS No.: 40546-94-9

Cat No.: VL460008

Tolterodine Mesyl Impurity

Parent: Tolterodine

CAS No.: 882878-66-2

Cat No.: VE0026000

Tolterodine Mixture of Diastereomer

Parent: Tolterodine

CAS No.: 209747-04-6

Cat No.: VL460005

Tolterodine Monomer Impurity

Parent: Tolterodine

CAS No.: N/A

Cat No.: VL460004

Tolterodine Monomer Impurity (Free Base)

Parent: Tolterodine

CAS No.: 194482-41-2

Cat No.: VE0010262

Tolterodine P- Cresol

Parent: Tolterodine

CAS No.: 106-44-5

Cat No.: VL460011

Tolterodine Tartrate Working Standard (Secondary Reference Standard)

Parent: Tolterodine / Tolterodine Tartrate

CAS No.: 124937-52-6

Cat No.: VE0027373

Tolterodine Trans Cinnamic Acid

Parent: Tolterodine

CAS No.: 140-10-3

Cat No.: VL460013

Tolterodine Related Compound

Impurities in tolterodine can arise from its chemical synthesis, formulation, or degradation over time. Monitoring and controlling these impurities are crucial according to ICH Q3A/B guidelines.

Types of Impurities in Tolterodine

Process-Related Impurities

Unreacted intermediates (e.g., isopropylphenol derivatives)
By-products from quaternization and alkylation steps
Residual solvents like methanol, acetone, or ethyl acetate

Degradation Impurities

Oxidized forms (e.g., oxidation at tertiary amine group)
Hydrolysis products under moist or acidic conditions
Isomeric impurities due to stereoisomer conversion

Elemental Impurities

Trace metals like iron, copper, or palladium from catalysts or manufacturing equipment

Analytical Techniques for Impurity Detection

High-Performance Liquid Chromatography (HPLC)
Liquid Chromatography–Mass Spectrometry (LC-MS)
Gas Chromatography (GC) for residual solvents
Fourier-Transform Infrared Spectroscopy (FT-IR)
ICP-MS for elemental impurity analysis

FAQ