Description

Tolterodine Impurity 1 CAS NO 88407-28-7 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient (API) Tolterodine. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and quality control testing.

Application

• Pharmaceutical Quality Control (QC): Used as a certified reference standard for the identification and quantification of this specific impurity in Tolterodine API and finished drug products.
• Analytical Method Development & Validation: Essential for developing and validating chromatographic methods (e.g., HPLC, UPLC) to monitor impurity profiles.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing definitive proof of impurity characterization and control strategies.
• Stability Studies: Employed to track the formation and level of this impurity during forced degradation and long-term stability testing of Tolterodine formulations.
• Research & Development (R&D): Used in synthetic chemistry research to study the formation pathways and chemical behavior of this impurity.
• Contract Research Organizations (CROs): Utilized by CROs providing analytical testing services to the pharmaceutical industry.

Basic Information

Product Name	Tolterodine Impurity 1
CAS No.	88407-28-7
Molecular Formula	C22H31NO
Molecular Weight	325.49 g/mol
Synonyms	(R)-N,N-Diisopropyl-3-(2-hydroxy-5-methylphenyl)-3-phenylpropanamine; (R)-Tolterodine Impurity 1; Tolterodine Related Compound A; (R)-2-[3-(Diisopropylamino)-1-phenylpropyl]-4-methylphenol; Tolterodine EP Impurity A; Tolterodine USP Impurity A; (3R)-N,N-Diisopropyl-3-(2-hydroxy-5-methylphenyl)-3-phenylpropan-1-amine
EINECS	Contact for details

Quality Control

Our Tolterodine Impurity 1 is manufactured under strict quality systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity and identity confirmation (IR, NMR), to ensure it meets the stringent requirements for pharmaceutical reference standards. A detailed Certificate of Analysis (COA) containing batch-specific data is provided with every shipment to support your regulatory and quality assurance needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing under inert atmosphere to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
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.