Description

Emtricitabine Impurity 18 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient (API) Emtricitabine. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling studies.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specific impurities in Emtricitabine API and its drug products.
• Analytical Method Development: Essential for developing and validating chromatographic methods (HPLC, UPLC) to monitor impurity levels during manufacturing.
• Quality Control (QC) & Quality Assurance (QA): Serves as a primary standard in routine QC testing to ensure batch-to-batch consistency and compliance with pharmacopeial specifications (USP, EP).
• Stability Studies: Employed to track the formation of degradation products in Emtricitabine formulations under various stress conditions.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to establish impurity thresholds and control strategies.
• Research & Development: Used in R&D to study the degradation pathways and chemical behavior of Emtricitabine.

Basic Information

Product Name	Emtricitabine Impurity 18
CAS No.	1091585-26-0
Molecular Formula	C8H10FN3O3S
Molecular Weight	247.25 g/mol
Synonyms	Emtricitabine Related Compound 18; FTC Impurity 18; 5-Fluoro-1-[(2R,5S)-2-(hydroxymethyl)-1,3-oxathiolan-5-yl]cytosine Impurity; 1,3-Oxathiolane, 2-(hydroxymethyl)-5-(4-amino-5-fluoro-2-oxo-1(2H)-pyrimidinyl)-, (2R,5S)-; Emtricitabine EP Impurity G; Emtricitabine USP Impurity 18
EINECS	Contact for details

Quality Control

Every batch of Emtricitabine Impurity 18 is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure identity, purity, and traceability. Our products are characterized using advanced techniques including HPLC, MS, and NMR to meet the stringent requirements for pharmaceutical reference standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and confirming compliance with relevant standards.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. The material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%

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