Description

Enclomiphene Impurity 6 is a designated reference standard used for the identification and quantification of process-related impurities in the active pharmaceutical ingredient (API) enclomiphene citrate. This compound is critical for ensuring the purity, safety, and efficacy of pharmaceutical products during development and manufacturing. It is primarily required by pharmaceutical companies, analytical laboratories, and regulatory bodies for quality control, method validation, and stability studies.

Application

• Pharmaceutical Impurity Profiling and Control: Serves as a certified reference material (CRM) for the identification and quantification of a specific impurity in enclomiphene citrate API batches.
• Analytical Method Development and Validation (HPLC/LC-MS): Used as a critical standard to develop, validate, and verify chromatographic methods for purity analysis.
• Stability Indicating Studies: Employed to monitor the formation of this impurity during forced degradation and long-term stability studies of drug substances and products.
• Regulatory Compliance and Documentation: Essential for preparing regulatory submission documents (e.g., for FDA, EMA) that require detailed impurity characterization and control strategies.
• Quality Control (QC) Testing: Used in routine QC laboratories to set specification limits and ensure batch-to-batch consistency of the final API.
• Research and Development: Aids in process chemistry research to understand and minimize the formation of this impurity during synthesis.

Basic Information

Product Name	Enclomiphene Impurity 6
CAS No.	47648-28-2
Molecular Formula	C26H28ClNO
Molecular Weight	405.96 g/mol
Synonyms	Zuclomiphene Impurity 6; (E)-4-[(2-Chloro-1,2-diphenylethenyl)oxy]-N,N-diethylbenzenamine; trans-Clomiphene Impurity 6; Enclomiphene Related Compound 6; Zuclomiphene Related Compound 6; (E)-Clomiphene Impurity; (E)-2-[4-(Diethylamino)ethoxy]phenyl]-1,2-diphenyl-1-chloroethylene
EINECS	Contact for details

Quality Control

Our Enclomiphene Impurity 6 is manufactured and handled under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity confirmation and identity verification by spectroscopic methods (IR, MS, NMR). We provide a detailed Certificate of Analysis (COA) with each shipment, which includes batch-specific data on purity, impurities, and chromatographic profiles. Our standards are suitable for use in cGMP and ISO 17025 accredited environments.

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. The material is hygroscopic (moisture-sensitive) and should be kept in a dry environment. 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)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 5.0%
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.