Description

(Raloxifene Impurity) CAS NO 1159977-58-8 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 Raloxifene hydrochloride, a selective estrogen receptor modulator (SERM) used in pharmaceutical formulations. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions involved in drug development and quality control. The impurity standard is essential for method validation, stability studies, and meeting stringent pharmacopeial requirements.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specific impurities in Raloxifene API and finished dosage forms.
• Analytical Method Development and Validation: Serves as a critical standard for developing, calibrating, and validating HPLC, UPLC, or LC-MS methods in quality control laboratories.
• Stability Studies: Employed to monitor the formation of degradation products in Raloxifene formulations under various stress conditions (e.g., heat, light, humidity).
• Regulatory Compliance and Submissions: Essential for preparing documentation that meets the requirements of regulatory bodies like the FDA, EMA, and ICH guidelines for impurity reporting.
• Research and Development: Used in synthetic chemistry and pharmacology research to study the metabolic pathways and degradation behavior of Raloxifene.
• Quality Assurance/Quality Control (QA/QC): Acts as a system suitability standard and for routine batch release testing to ensure product purity and consistency.

Basic Information

Item	Details
Product Name	(Raloxifene Impurity) CAS NO 1159977-58-8
CAS No.	1159977-58-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Raloxifene Related Compound; Raloxifene Impurity Standard; Raloxifene Hydrochloride Impurity; 6-Hydroxy-2-(4-hydroxyphenyl)benzo[b]thien-3-yl 4-[2-(1-Piperidinyl)ethoxy]phenyl Methanone Impurity; Benzothiophene Impurity; SERM Impurity; Pharmaceutical Reference Standard
EINECS	Contact for details

Quality Control

Our (Raloxifene Impurity) CAS NO 1159977-58-8 is manufactured and handled under strict quality management systems. Each batch undergoes rigorous analytical testing, including chromatographic purity analysis and spectroscopic identification, to ensure it meets the high standards required for pharmaceutical reference materials. Certificates of Analysis (COA) detailing batch-specific results are provided and traceable to primary standards. Our quality commitment aligns with ICH Q3A, Q3B, and relevant pharmacopeial guidelines for impurity characterization.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or Certificate of Analysis. Keep the container in a dry, cool, and well-ventilated area. For long-term storage, consider storing under inert atmosphere to prevent potential degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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