Description

Emtricitabine Dimer Impurity is a high-purity reference standard critical for analytical method development and validation in pharmaceutical quality control. This compound is essential for accurately identifying, quantifying, and controlling a key process-related impurity in the synthesis of the antiretroviral drug Emtricitabine. It is primarily required by pharmaceutical manufacturers, contract research organizations (CROs), and analytical testing laboratories to ensure drug safety, efficacy, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the quantitative and qualitative analysis of Emtricitabine drug substance and finished products.
• Impurity Profiling and Control: Critical for establishing specification limits and monitoring levels of this dimer impurity during active pharmaceutical ingredient (API) manufacturing and stability studies.
• Analytical Method Development: Serves as a key component in developing and validating HPLC, UPLC, or LC-MS methods for impurity detection and separation.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to meet FDA, EMA, and ICH guidelines.
• Quality Assurance/Quality Control (QA/QC): Employed in routine batch release testing to ensure the impurity profile of Emtricitabine meets stringent pharmacopeial standards (USP, EP).
• Stability Studies: Used to track the formation and growth of this specific impurity under various stress conditions (heat, light, humidity) as per ICH Q1A(R2) requirements.

Basic Information

Product Name	Emtricitabine Dimer Impurity
CAS No.	1962114-97-1
Molecular Formula	C16H22N6O5S2
Molecular Weight	442.52 g/mol
Synonyms	Emtricitabine Dimer; FTC Dimer Impurity; 5-Fluoro-1-[(2R,5S)-2-(hydroxymethyl)-1,3-oxathiolan-5-yl]cytosine Dimer; 1,3-Oxathiolane, 2-[[(1R,2S)-2-(4-amino-5-fluoro-2-oxo-1(2H)-pyrimidinyl)-1-(hydroxymethyl)-2-(1,3-oxathiolanyl)]oxy]methyl]-5-[(5-fluoro-4-amino-2-oxo-1(2H)-pyrimidinyl)]-; Emtricitabine Related Compound Dimer
EINECS	Contact for details

Quality Control

Every batch of Emtricitabine Dimer Impurity is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques (HPLC, LC-MS, NMR) to ensure compliance with pharmaceutical reference standard requirements. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry, cool place. This material is hygroscopic (moisture-sensitive) and must be kept under inert atmosphere or in a desiccator after opening to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 95.0%
Water Content (KF)	≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Specific Rotation	Contact for details

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