Description

Emtricitabine Impurity 8 is a high-purity reference standard used for the analytical profiling and quality control of the active pharmaceutical ingredient (API) Emtricitabine. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure product safety, efficacy, and regulatory compliance by accurately identifying and quantifying process-related impurities. It is essential for research and development, method validation, and stability studies within the pharmaceutical industry, particularly for antiviral drug production.

Application

• Pharmaceutical Reference Standard for HPLC, GC, and LC-MS analysis.
• Identification and quantification of impurities in Emtricitabine API batches.
• Method development and validation for quality control laboratories.
• Stability indicating studies and forced degradation studies.
• Calibration standard for analytical instrumentation.
• Research and development of antiviral drug formulations.
• Regulatory compliance and submission support (e.g., for FDA, EMA).
• Training and educational purposes in analytical chemistry.

Basic Information

Product Name	Emtricitabine Impurity 8
CAS No.	64282-88-8
Molecular Formula	C8H10FN3O3S
Molecular Weight	247.25 g/mol
Synonyms	5-Fluoro-1-[(2R,5S)-2-(hydroxymethyl)-1,3-oxathiolan-5-yl]cytosine; FTC Related Compound; 2'-Deoxy-5-fluoro-3'-thiacytidine Impurity; Emtricitabine EP Impurity; Emtricitabine USP Impurity; (-)-FTC Impurity; Coviracil Impurity; 5-Fluoro-1-[(2R,5S)-2-(hydroxymethyl)-1,3-oxathiolan-5-yl]-1,2-dihydropyrimidin-2-one
EINECS	Contact for details

Quality Control

Our Emtricitabine Impurity 8 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC purity, identity confirmation (IR, NMR), and residual solvent analysis, to ensure it meets the stringent requirements for a pharmaceutical reference standard. Certificates of Analysis (COA) with detailed chromatograms and spectral data are provided to support your regulatory and quality assurance needs.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at 2-8°C. This product is hygroscopic (moisture-sensitive) and should be handled under controlled humidity conditions to prevent degradation. Allow the sealed vial to equilibrate to room temperature before opening to minimize moisture uptake.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH guidelines

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