Description

Tamoxifen Citrate Ep Impurity C is a specified impurity associated with the active pharmaceutical ingredient Tamoxifen Citrate. This compound is critical for pharmaceutical quality control and analytical method development, ensuring the safety and efficacy of the final drug product. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for use as a certified reference standard in impurity profiling and compliance testing.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the quality control of Tamoxifen Citrate API and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing and validating HPLC, UPLC, or other chromatographic methods for impurity detection and quantification.
• Stability Studies: Employed in forced degradation and long-term stability studies to monitor impurity formation in Tamoxifen-based drug products.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., ANDA, NDA) by providing impurity identification and characterization data for health authorities like the FDA and EMA.
• Research & Development: Used in R&D to study the degradation pathways and metabolism of Tamoxifen Citrate.
• Pharmacopoeial Testing: Applied in testing to meet the specifications of pharmacopoeias such as the European Pharmacopoeia (EP) and United States Pharmacopeia (USP).

Basic Information

Product Name	Tamoxifen Citrate Ep Impurity C
CAS No.	19957-51-8
Molecular Formula	C32H37NO8
Molecular Weight	563.64 g/mol
Synonyms	(Z)-2-[4-[(1E)-1,2-Diphenyl-1-buten-1-yl]phenoxy]-N,N-dimethylethanamine Citrate; Tamoxifen Citrate Impurity C; Tamoxifen EP Impurity C; (Z)-Tamoxifen Citrate Impurity C; trans-Tamoxifen Citrate Impurity; ICI 46474 Impurity C; Nolvadex Impurity C
EINECS	Contact for details

Quality Control

Every batch of Tamoxifen Citrate Ep Impurity C is manufactured and controlled under a strict quality management system. The product undergoes comprehensive analytical testing, including HPLC for purity and identity confirmation via spectroscopic methods, to ensure it meets the stringent requirements for a pharmaceutical reference material. A detailed Certificate of Analysis (COA) providing batch-specific data is supplied with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C (59-77°F). The product is light-sensitive and should be handled under appropriate conditions to maintain stability.

Specification

Item	Specification
Appearance	White to off-white powder
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 guidelines
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.