Description

Emtricitabine Impurity 17 is a high-purity 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 & Validation: Serves as a critical standard for developing, calibrating, and validating HPLC, UPLC, and LC-MS methods in quality control laboratories.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submissions (e.g., for FDA, EMA) to demonstrate comprehensive impurity control and meet ICH Q3A/B guidelines.
• Stability Studies: Employed to monitor the formation and levels of this impurity during forced degradation and long-term stability testing of Emtricitabine formulations.
• Research & Development: Used in R&D to study the degradation pathways, synthesis by-products, and metabolic profiles related to Emtricitabine.
• Quality Control Testing: Acts as a system suitability and identification standard in the routine QC release testing of Emtricitabine batches.

Basic Information

Product Name	Emtricitabine Impurity 17
CAS No.	2101981-64-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	FTC Impurity 17; Emtricitabine Related Compound 17; 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; Emtricitabine EP Impurity I; Emtricitabine Process Impurity; (-)-FTC Impurity 17
EINECS	Contact for details

Quality Control

Our Emtricitabine Impurity 17 is manufactured under strict quality systems to ensure it meets the exacting standards for pharmaceutical reference materials. Each batch undergoes comprehensive analytical characterization using techniques such as HPLC, LC-MS, NMR, and IR to confirm identity and purity. A detailed Certificate of Analysis (COA) providing batch-specific data is supplied with every product, supporting compliance with ICH, USP, and EP guidelines.

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 Certificate of Analysis. Keep the container in a dry, cool, and well-ventilated area.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C

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