Description

Tamoxifen Ep Impurity H is a specified impurity of the active pharmaceutical ingredient Tamoxifen, a non-steroidal anti-estrogen medication. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure the purity, safety, and efficacy of Tamoxifen-based drug products. It serves as a key reference standard for quality control and regulatory compliance in the pharmaceutical industry. Professionals in pharmaceutical R&D, quality assurance, and contract research organizations rely on this high-purity impurity for method development and validation.

Application

• Primary use as a pharmaceutical reference standard for the identification and quantification of impurities in Tamoxifen API and finished dosage forms.
• Critical component in analytical method development and validation (HPLC, UPLC, GC) for stability-indicating assays.
• Essential for conducting stability studies and forced degradation studies to understand impurity profiles.
• Used in regulatory submissions (e.g., ANDA, NDA) to establish impurity limits as per ICH Q3A and Q3B guidelines.
• Supports quality control laboratories in routine batch release testing of Tamoxifen.
• Valuable for academic and clinical research investigating the metabolism and pharmacokinetics of Tamoxifen.

Basic Information

Product Name	Tamoxifen Ep Impurity H
CAS No.	809285-09-4
Molecular Formula	C26H29NO
Molecular Weight	371.52 g/mol
Synonyms	(Z)-2-[4-[(E)-1,2-Diphenylbut-1-en-1-yl]phenoxy]-N,N-dimethylethanamine; Tamoxifen Impurity H; Tamoxifen EP Impurity H; (Z)-Tamoxifen; Geometric Isomer of Tamoxifen; trans-Tamoxifen; ICI 47699; Z-Tamoxifen
EINECS	Contact for details

Quality Control

Every batch of Tamoxifen Ep Impurity H is manufactured and controlled under a strict quality management system. The product undergoes comprehensive analytical testing, including identification by spectroscopic methods (IR, NMR, MS), purity determination by HPLC, and control of related substances and residual solvents. A Certificate of Analysis (COA) is provided with each shipment, detailing the results against predefined specifications. Our quality standards are designed to meet the rigorous demands of pharmaceutical reference material applications and support compliance with pharmacopeial (EP, USP) and ICH guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider storing under an inert atmosphere to prevent oxidation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual 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.