Description

Tolterodine Impurity 13 is a high-purity chemical reference standard used in the pharmaceutical development and quality control processes. This compound is critical for ensuring the safety and efficacy of Tolterodine, an active pharmaceutical ingredient (API) used in the treatment of overactive bladder. It serves as a key analytical marker for identifying and quantifying process-related impurities. Pharmaceutical manufacturers, analytical laboratories, and regulatory bodies require this standard to meet stringent pharmacopeial guidelines and ensure batch-to-batch consistency.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Tolterodine-related impurities in API and finished drug products.
• Analytical Method Development & Validation: Essential for developing, calibrating, and validating chromatographic methods, such as HPLC and UPLC, in quality control laboratories.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., ANDA, NDA) by providing necessary impurity profiles and data for health authority submissions like the FDA and EMA.
• Stability Studies & Forced Degradation Testing: Used to monitor impurity formation during drug product stability testing and to understand degradation pathways.
• Process Chemistry & Optimization: Aids chemists in monitoring and minimizing the formation of this specific impurity during the synthesis and purification of Tolterodine API.
• Quality Assurance/Quality Control (QA/QC): Integral for routine batch release testing to ensure impurity levels are within International Council for Harmonisation (ICH) specified limits.

Basic Information

Item	Detail
Product Name	Tolterodine Impurity 13
CAS No.	88407-29-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	5-Hydroxymethyl Tolterodine; Tolterodine Related Compound 13; Tolterodine Hydroxymethyl Impurity; (R)-2-[3-(Diisopropylamino)-1-phenylpropyl]-4-(hydroxymethyl)phenol; Tolterodine EP Impurity H; Tolterodine USP Impurity 13; Tolterodine Metabolite Hydroxymethyl Derivative
EINECS	Contact for details

Quality Control

Our Tolterodine Impurity 13 is manufactured under strict quality systems to ensure it meets the exacting standards required for pharmaceutical analysis. Each batch is characterized and tested using advanced analytical techniques, including HPLC, GC, MS, and NMR, to confirm identity, purity, and strength. We provide comprehensive Certificates of Analysis (COA) with detailed chromatographic data, including retention time and relative response factor where applicable. The material is suitable for use in methods compliant with USP, EP, ICH, and other international pharmacopeial guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15°C and 25°C (59°F and 77°F), in a dry environment. Keep the container sealed to protect the material from moisture absorption and contamination.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Main peak retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any single unknown impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 5.0% w/w

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