Description

Bazedoxifene Impurity 1 is a designated impurity of the active pharmaceutical ingredient Bazedoxifene, a selective estrogen receptor modulator (SERM). This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method validation and quality control processes. It is essential for manufacturers and analytical laboratories focused on ensuring the purity, safety, and regulatory compliance of Bazedoxifene-based drug products.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Bazedoxifene API and finished dosage forms.
• Analytical Method Development & Validation: Critical for developing and validating HPLC, UPLC, and LC-MS methods to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): Used in routine batch testing to ensure API and drug product specifications meet pharmacopeial standards (e.g., USP, EP).
• Stability Studies: Employed to track the formation and levels of this specific impurity under various stress conditions (heat, light, humidity).
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Process Chemistry Research: Aids in understanding and optimizing synthesis pathways to minimize the formation of this impurity.

Basic Information

Product Name	Bazedoxifene Impurity 1
CAS No.	1802552-29-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Bazedoxifene Related Compound 1; Bazedoxifene Impurity A; Bazedoxifene EP Impurity 1; Bazedoxifene USP Impurity 1; 1-[4-(2-(Hexahydro-1H-azepin-1-yl)ethoxy)phenyl]-2-phenyl-1H-indol-5-ol Impurity; TSE-424 Impurity 1
EINECS	Contact for details

Quality Control

Every batch of Bazedoxifene Impurity 1 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced chromatographic (HPLC, LC-MS) and spectroscopic (NMR, IR) techniques to ensure compliance with pharmacopeial and customer-specific standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept under inert conditions or in a desiccator to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any single unknown impurity ≤ 1.0%
Water Content (KF)	≤ 5.0%
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.