Description

Enclomiphene Impurity 4 is a high-purity reference standard and analytical impurity crucial for pharmaceutical research and development. This compound is essential for the quality control and regulatory compliance of Enclomiphene, a selective estrogen receptor modulator (SERM) under investigation. It is primarily used by pharmaceutical manufacturers, contract research organizations (CROs), and analytical laboratories to ensure product purity, safety, and efficacy through precise identification and quantification of related substances.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of impurities in Enclomiphene active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Critical for developing, calibrating, and validating HPLC, UPLC, and LC-MS methods in quality control laboratories.
• Stability Studies: Used to monitor the formation of degradation products in Enclomiphene under various stress conditions (e.g., heat, light, humidity) as per ICH guidelines.
• Regulatory Submissions: Provides necessary impurity data for Drug Master Files (DMFs), Investigational New Drug (IND) applications, and New Drug Applications (NDAs) to agencies like the FDA and EMA.
• Process Chemistry R&D: Aids in the optimization of synthetic routes by identifying and tracking process-related impurities.
• Pharmacological Research: Used in studies to understand the metabolic pathways and potential biological activity of Enclomiphene-related compounds.

Basic Information

Item	Detail
Product Name	Enclomiphene Impurity 4
CAS No.	117884-82-9
Molecular Formula	C26H28ClNO
Molecular Weight	405.96 g/mol
Synonyms	Zuclomiphene Impurity 4; (E)-4-[(2-{4-[(Z)-2-Chloro-1,2-diphenylethenyl]phenoxy}ethyl)amino]but-3-en-2-one; Enclomiphene Related Compound 4; trans-Enclomiphene Impurity; Enclomiphene EP Impurity D; Zuclomiphene Isomer Impurity; 117884-82-9
EINECS	Contact for details

Quality Control

Our Enclomiphene Impurity 4 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC purity assay, identity confirmation (IR, MS), and residual solvent analysis, to ensure it meets the stringent requirements for pharmaceutical reference standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing all test results and confirming compliance with specified standards.

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 COA. The material is light-sensitive and should be handled under appropriate conditions to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5% w/w

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