Description

Clomiphene-D5 Citrate is a deuterated internal standard of the selective estrogen receptor modulator (SERM) clomiphene citrate, specifically designed for high-precision analytical applications. This stable isotope-labeled compound is essential for ensuring the accuracy and reliability of quantitative mass spectrometry analyses, providing critical data integrity in regulated environments. It is primarily utilized by pharmaceutical R&D laboratories, contract research organizations (CROs), and analytical testing facilities involved in drug metabolism, pharmacokinetic studies, and bioanalytical method development.

Application

• Quantitative Bioanalysis: Serves as an internal standard in LC-MS/MS and GC-MS methods for the precise quantification of clomiphene and its metabolites in biological matrices (plasma, serum, urine).
• Pharmacokinetic/Pharmacodynamic (PK/PD) Studies: Enables accurate tracking of drug absorption, distribution, metabolism, and excretion (ADME) in clinical and pre-clinical research.
• Drug Metabolism Research: Used in metabolite identification and profiling studies to understand the biotransformation pathways of clomiphene.
• Method Development and Validation: Critical for developing, optimizing, and validating robust analytical methods in compliance with FDA, EMA, and ICH guidelines.
• Quality Control in Manufacturing: Supports impurity profiling and assay verification during the pharmaceutical manufacturing process of clomiphene citrate.
• Forensic and Doping Control Analysis: Applied in confirmatory testing for clomiphene in forensic toxicology and anti-doping programs in sports.

Basic Information

Product Name	Clomiphene-D5 Citrate
CAS No.	1217200-17-3
Molecular Formula	C32H31D5ClNO8 • C6H8O7
Molecular Weight	Contact for details
Synonyms	2-[4-(2-Chloro-1,2-diphenylvinyl)phenoxy]-N,N-diethyl-ethanamine-2,3,4,5,6-D5 Citrate; Clomifene-D5 Citrate; Clomid-D5; Clomiphene-d5 (1:1) citrate salt; [2,3,4,5,6-2H5]Clomiphene Citrate; Deuterated Clomiphene Citrate; (Z)-2-[4-(1,2-Diphenyl-2-chlorovinyl)phenoxy]triethylamine-d5 Citrate
EINECS	Contact for details

Quality Control

Our Clomiphene-D5 Citrate is manufactured under strict quality systems to ensure the high chemical purity and isotopic enrichment required for analytical standards. Each batch is characterized by advanced spectroscopic and chromatographic techniques, including NMR, HPLC, and mass spectrometry, to confirm identity, purity, and deuterium incorporation. A comprehensive Certificate of Analysis (COA) is provided, detailing batch-specific results for assay, isotopic purity, and related substances. We support compliance with GMP/GLP principles for use in regulated laboratories.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability. For long-term storage, consider desiccant in the container.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥98.0%
Isotopic Purity (D5)	≥98.0 atom % D
Chemical Purity (NMR)	Conforms
Water Content (KF)	≤2.0%
Residue on Ignition	≤0.5%

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