Description

Bazedoxifene Impurity 5 is a designated impurity standard of the selective estrogen receptor modulator (SERM) Bazedoxifene. This high-purity reference material is critical for analytical method development, validation, and quality control in pharmaceutical manufacturing. It is primarily required by pharmaceutical companies, contract research organizations (CROs), and analytical laboratories involved in the development and production of Bazedoxifene acetate API and its formulations.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of Bazedoxifene Impurity 5 in active pharmaceutical ingredient (API) batches.
• Analytical Method Development: Used to develop and optimize chromatographic methods (HPLC, UPLC) for impurity profiling of Bazedoxifene.
• Quality Control & Assurance (QC/QA): Essential for routine quality control testing to monitor impurity levels and ensure API compliance with ICH Q3A/B guidelines.
• Stability Studies: Employed as a marker to track the formation of this specific impurity during forced degradation and long-term stability studies of drug substances and products.
• Regulatory Submissions: Provides necessary impurity characterization data for regulatory filings (e.g., FDA, EMA) to support drug approval and specification setting.
• Research & Development: Used in pharmaceutical R&D to understand the degradation pathways and synthesis-related impurities of Bazedoxifene.

Basic Information

Product Name	Bazedoxifene Impurity 5
CAS No.	389795-08-8
Molecular Formula	C30H34N2O3
Molecular Weight	470.60 g/mol
Synonyms	1-[[4-[2-(Hexahydro-1H-azepin-1-yl)ethoxy]phenyl]methyl]-2-(4-hydroxyphenyl)-3-methyl-1H-indol-5-ol; Bazedoxifene Related Compound; Bazedoxifene Impurity; Bazedoxifene Acetate Impurity; LY353381.HCl Impurity; TSE-424 Impurity; (2-(4-((2-(4-Hydroxyphenyl)-3-methyl-5-hydroxy-1H-indol-1-yl)methyl)phenoxy)ethyl)azepane
EINECS	Contact for details

Quality Control

Every batch of Bazedoxifene Impurity 5 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques (HPLC, GC, NMR, MS) to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results, including chromatographic purity and structural confirmation data, 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 compound is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

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)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0%

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