Description

Tamoxifen Ep Impurity D is a specified impurity and reference standard used in the analytical profiling of Tamoxifen Citrate, a critical active pharmaceutical ingredient (API). This compound is essential for pharmaceutical quality control and regulatory compliance, ensuring the purity and safety of the final drug product. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions involved in the development, production, and quality assurance of Tamoxifen-based therapies.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of impurities in Tamoxifen Citrate API and finished dosage forms.
• Analytical Method Development & Validation: Used to develop, optimize, and validate chromatographic methods, such as HPLC and UPLC, for impurity profiling.
• Quality Control & Assurance (QC/QA): Critical for routine batch testing to monitor impurity levels and ensure compliance with pharmacopeial specifications (e.g., USP, EP, ICH Q3A/B).
• Stability Studies: Employed to track the formation of degradation products in Tamoxifen formulations under various stress conditions.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDA).
• Research & Development: Used in synthetic chemistry research to study the degradation pathways and metabolism of Tamoxifen.

Basic Information

Product Name	Tamoxifen Ep Impurity D
CAS No.	197251-11-9
Molecular Formula	C26H29NO
Molecular Weight	371.52 g/mol
Synonyms	(Z)-2-[4-[(1E)-1,2-Diphenyl-1-buten-1-yl]phenoxy]-N,N-dimethylethanamine; Tamoxifen Impurity D; (Z)-Tamoxifen; Tamoxifen EP Impurity D; Tamoxifen Related Compound D; trans-Tamoxifen; ICI 47699; NSC-180973; Z-Tamoxifen
EINECS	Contact for details

Quality Control

Every batch of Tamoxifen Ep Impurity D is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced analytical techniques to ensure compliance with pharmacopeial standards and customer specifications. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results for purity, related substances, and other critical parameters.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing at 2-8°C. Handle the material under appropriate laboratory conditions to prevent contamination.

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)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5%

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