Description

Tamoxifen Impurity 3 is a designated impurity standard used in the analytical profiling of the active pharmaceutical ingredient (API) Tamoxifen Citrate. This compound is critical for ensuring the quality, safety, and efficacy of Tamoxifen-based pharmaceutical formulations through rigorous impurity identification and quantification. It is an essential reference material for pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in quality control, method development, and stability studies.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the quality control of Tamoxifen Citrate API and finished dosage forms.
• Analytical Method Development & Validation: Used to develop, optimize, and validate HPLC, UPLC, and other chromatographic methods for impurity profiling.
• Stability Studies & Forced Degradation: Employed to identify and monitor degradation products in Tamoxifen formulations under various stress conditions.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission dossiers (e.g., for FDA, EMA) that require detailed impurity characterization.
• Pharmacopoeial Testing: Used as a system suitability and identification standard in compliance with USP, EP, or other pharmacopoeial monographs.
• Research & Development: Supports synthetic chemistry research and the development of impurity control strategies during API manufacturing.

Basic Information

Product Name	Tamoxifen Impurity 3
CAS No.	5435-24-5
Molecular Formula	C26H29NO
Molecular Weight	371.52 g/mol
Synonyms	Z-Tamoxifen; (Z)-1-[4-[2-(Dimethylamino)ethoxy]phenyl]-1,2-diphenyl-1-butene; (Z)-Tamoxifen; cis-Tamoxifen; Tamoxifen (Z)-isomer; Tamoxifen Impurity C; ICI 47699 (Z-isomer); trans-Tamoxifen Isomer
EINECS	226-614-5

Quality Control

Our Tamoxifen Impurity 3 is manufactured and handled under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC purity, identity confirmation (IR, NMR), and residual solvent analysis, to ensure it meets the stringent requirements for a pharmaceutical reference standard. A detailed Certificate of Analysis (COA) containing batch-specific data is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C (59-77°F). The material is light-sensitive (store away from light).

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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