Description

Emtricitabine Impurity 15 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 standard for the identification and quantification of specific impurities in Emtricitabine API and finished drug products.
• Analytical Method Development & Validation: Essential for developing, calibrating, and validating chromatographic methods (e.g., HPLC, UPLC) to ensure accurate impurity detection.
• Quality Control & Assurance (QC/QA): Serves as a benchmark in routine quality control testing to monitor batch-to-batch consistency and purity of Emtricitabine.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing necessary data for impurity identification and qualification as per ICH guidelines.
• Stability Studies: Employed in forced degradation and long-term stability studies of Emtricitabine to understand impurity formation pathways.
• Research & Development (R&D): Used in synthetic chemistry research to study the formation, isolation, and characterization of process-related impurities.

Basic Information

Product Name	Emtricitabine Impurity 15
CAS No.	1238210-22-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	FTC Impurity 15; Emtricitabine Related Compound 15; 4-Amino-5-fluoro-1-[(2R,5S)-2-(hydroxymethyl)-1,3-oxathiolan-5-yl]-1,2-dihydropyrimidin-2-one; 5-Fluoro-1-[(2R,5S)-2-(hydroxymethyl)-1,3-oxathiolan-5-yl]cytosine Impurity; (-)-FTC Impurity 15; Emtricitabine EP Impurity C; Emtricitabine Process Impurity
EINECS	Contact for details

Quality Control

Our Emtricitabine Impurity 15 is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation via spectroscopic methods (IR, NMR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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