Description

Lasofoxifene 2-Oxide is a key pharmaceutical intermediate and metabolite of the selective estrogen receptor modulator (SERM) Lasofoxifene. This compound is of significant importance for research and development in the fields of endocrinology and oncology, particularly in studies related to breast cancer and osteoporosis. It is primarily utilized by pharmaceutical R&D laboratories, contract research organizations (CROs), and manufacturers of active pharmaceutical ingredients (APIs) for analytical reference standards, metabolic pathway studies, and impurity profiling.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for quality control and analytical method development in API manufacturing.
• Metabolite Research: Critical for in-vitro and in-vivo studies investigating the metabolic pathways, pharmacokinetics, and bioavailability of Lasofoxifene.
• Impurity Identification and Control: Used to identify, quantify, and monitor process-related impurities and degradation products in Lasofoxifene-based drug formulations.
• Biochemical Research: Employed in mechanistic studies to understand estrogen receptor interactions and the pharmacological profile of SERMs.
• Regulatory Submissions: Provides essential data for drug master files (DMFs) and regulatory dossiers submitted to agencies like the FDA and EMA.

Basic Information

Product Name	Lasofoxifene 2-Oxide
CAS No.	366017-88-1
Molecular Formula	C28H31NO4F2
Molecular Weight	483.55 g/mol
Synonyms	(5R,6S)-6-Phenyl-5-[4-(2-pyrrolidin-1-ylethoxy)phenyl]-5,6,7,8-tetrahydronaphthalen-2-ol 2-Oxide; Lasofoxifene N-Oxide; CP-336,156 Oxide; Fablyn Impurity/Metabolite; (6S)-6-Phenyl-5-[4-[2-(1-pyrrolidinyl)ethoxy]phenyl]-5,6,7,8-tetrahydro-2-naphthalenol 2-Oxide
EINECS	Contact for details

Quality Control

Our Lasofoxifene 2-Oxide is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, NMR and MS for structural confirmation, and residual solvent analysis. We provide a detailed Certificate of Analysis (COA) with each shipment, ensuring traceability and compliance with cGMP guidelines for pharmaceutical intermediates. Specifications are designed to meet the stringent requirements of pharmacopeial standards.

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 ensure maximum stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Conforms to reference standard
Identification (IR)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0%
Single Unknown Impurity	≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5%

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