Description

5-Hydroxymethyl Tolterodine β-D-Glucuronide is a major, pharmacologically active metabolite of the antimuscarinic drug tolterodine. This compound is of critical importance in pharmaceutical research and development, particularly for pharmacokinetic and metabolic studies. It serves as a vital reference standard for analytical method development, bioequivalence testing, and regulatory compliance in the manufacturing of tolterodine-based therapeutics. Researchers and quality control laboratories in the global pharmaceutical and contract research organization (CRO) sectors require this high-purity compound to ensure accurate drug metabolism and pharmacokinetics (DMPK) data.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the quantification of tolterodine and its metabolites in biological matrices.
• Drug Metabolism and Pharmacokinetics (DMPK) Studies: Essential for investigating the metabolic pathways, clearance rates, and bioavailability of tolterodine in preclinical and clinical research.
• Analytical Method Development and Validation: Used to develop and validate sensitive HPLC, LC-MS, and LC-MS/MS methods for bioanalysis.
• Impurity Profiling and Control: Acts as a known impurity or degradation product standard to establish specifications for drug substance and product quality.
• Regulatory Submissions: Critical for compiling Investigational New Drug (IND) and New Drug Application (NDA) dossiers to meet FDA, EMA, and ICH guidelines.
• Bioequivalence Testing: Used in studies comparing generic formulations to the innovator tolterodine product.
• Clinical Toxicology: Aids in the accurate assessment of tolterodine levels in therapeutic drug monitoring and overdose cases.

Basic Information

Product Name	5-Hydroxymethyl Tolterodine β-D-Glucuronide
CAS No.	210573-52-7
Molecular Formula	C28H39NO9
Molecular Weight	533.62 g/mol
Synonyms	5-Hydroxymethyl Tolterodine Glucuronide; (R)-N,N-Diisopropyl-3-(2-hydroxy-5-(hydroxymethyl)phenyl)-3-phenylpropanaminium β-D-Glucopyranosiduronic Acid; Tolterodine Hydroxymethyl Glucuronide; 5-HM Tolterodine Glucuronide; DD 1452 Glucuronide; PNU-200583 Glucuronide; DD-1452 Glucuronide; Fesoterodine Related Compound (glucuronide metabolite of tolterodine)
EINECS	Contact for details

Quality Control

Our 5-Hydroxymethyl Tolterodine β-D-Glucuronide is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including identity confirmation by spectroscopic methods (NMR, IR, MS), purity assessment by HPLC, and control of specific impurities. We provide a detailed Certificate of Analysis (COA) with each shipment, which includes batch-specific data on purity, residual solvents, and other critical parameters. Our quality standards are designed to meet the rigorous requirements of pharmaceutical R&D and regulatory compliance.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C (59-77°F), or as indicated on the certificate of analysis/label. The compound is hygroscopic (moisture-sensitive); keep the container tightly sealed in a dry environment. For long-term storage, consider storing desiccated at -20°C.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Mass spectrum conforms to structure
Purity (HPLC)	≥ 95.0% (Area %)
Related Substances (HPLC)	Total impurities ≤ 5.0% Any single unknown impurity ≤ 1.0%
Water Content (KF)	≤ 5.0 % w/w
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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