Description

Clomiphene-D5 Hcl 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 accuracy and reliability in quantitative mass spectrometry, eliminating matrix effects and providing robust calibration. It is a critical reagent for pharmaceutical research and development, clinical laboratories, and forensic toxicology studies focusing on fertility treatments, hormone analysis, and drug metabolism. The product, identified as CAS NO 1346606-66-3, meets the stringent requirements for sensitive and specific bioanalytical method development.

Application

• Quantitative Bioanalysis: Serves as a primary internal standard for the accurate LC-MS/MS quantification of clomiphene and its metabolites in biological matrices (plasma, serum, urine).
• Pharmaceutical R&D: Used in pharmacokinetic (PK) and pharmacodynamic (PD) studies during the development of SERM-based therapies.
• Clinical Research & Diagnostics: Enables precise monitoring of drug levels in patients undergoing fertility treatment with clomiphene citrate.
• Forensic & Doping Control: Critical for confirmatory testing and compliance monitoring in anti-doping and forensic toxicology laboratories.
• Metabolite Identification: Aids in the structural elucidation and quantification of clomiphene metabolites in metabolism studies.
• Method Development & Validation: Provides a stable isotopic reference for developing, validating, and transferring robust analytical methods according to FDA/EMA guidelines.

Basic Information

Product Name	Clomiphene-D5 Hcl
CAS No.	1346606-66-3
Molecular Formula	C26H23D5ClNO • HCl
Molecular Weight	~ 431.4 g/mol (for monoisotopic mass)
Synonyms	Clomiphene-d5 hydrochloride; 2-[4-(2-Chloro-1,2-diphenylethenyl)phenoxy]-N,N-diethylethanamine-d5 hydrochloride; Zuclomiphene-d5 / Enclomiphene-d5 Mixture Hydrochloride; Clomid-d5 HCl; NSC-35770-d5 Hydrochloride; (Z/E)-Clomiphene-d5 Hydrochloride; 2-[p-(β-Chloro-α-phenylstyryl)phenoxy]triethylamine-d5 hydrochloride
EINECS	Contact for details

Quality Control

Every batch of Clomiphene-D5 Hcl is manufactured and tested under strict quality systems to ensure it meets the high-purity standards required for analytical reference materials. Our quality control protocol includes comprehensive characterization by NMR, MS, and HPLC to confirm chemical identity, isotopic purity (>98 atom % D), and chemical purity. A detailed Certificate of Analysis (COA) is provided with each shipment, documenting batch-specific results for assay, impurities, and residual solvents. We support compliance with GMP/GLP guidelines for research use.

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. This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Isotopic Purity	≥ 98 atom % D
Chemical Purity	≥ 95.0%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH limits

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