Description

Bazedoxifene Impurity 8 is a designated impurity reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Bazedoxifene. This compound is critical for ensuring the purity, safety, and efficacy of pharmaceutical formulations by serving as a benchmark in chromatographic analysis. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in drug development and quality assurance.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Bazedoxifene Impurity 8 in API and finished drug products.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods for impurity profiling.
• Quality Control & Release Testing: Employed in routine QC testing to monitor impurity levels and ensure batch-to-batch consistency and compliance with ICH Q3A/B guidelines.
• Stability Studies: Used to track the formation of this specific impurity during forced degradation and long-term stability studies of Bazedoxifene.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to establish impurity thresholds and control strategies.
• Research & Development: Supports synthetic route optimization and process chemistry research by identifying and characterizing process-related impurities.

Basic Information

Product Name	Bazedoxifene Impurity 8
CAS No.	1802552-31-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Bazedoxifene Related Compound 8; Bazedoxifene Impurity C; Bazedoxifene Process Impurity; 1-[4-(2-Azepan-1-ylethoxy)benzyl]-2-(4-hydroxyphenyl)-3-methyl-1H-indol-5-ol (proposed); UNII-XXXX; Bazedoxifene EP Impurity C; Bazedoxifene USP Impurity; Bazedoxifene API Impurity 8
EINECS	Contact for details

Quality Control

Our Bazedoxifene Impurity 8 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity determination and spectroscopic confirmation (NMR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. Certificates of Analysis (COA) with detailed chromatographic data, batch-specific results, and traceability information are provided to support your regulatory and quality needs.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent absorption of moisture.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 2.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C

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