Description

Emtricitabine Impurity 16 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 quality control testing.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of Emtricitabine Impurity 16 in Emtricitabine API and finished drug products.
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, and other chromatographic methods for impurity profiling.
• Quality Control & Assurance (QC/QA): Serves as a system suitability and calibration standard in routine quality control testing to monitor impurity levels against ICH guidelines.
• Regulatory Compliance & Filings: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity characterization data for drug master files (DMFs).
• Stability Studies: Employed to track the formation and growth of this specific impurity during forced degradation and long-term stability studies of Emtricitabine formulations.
• Research & Development: Used in R&D laboratories for studying the degradation pathways, synthesis, and chemical behavior of Emtricitabine.

Basic Information

Item	Detail
Product Name	Emtricitabine Impurity 16
CAS No.	1160303-44-5
Molecular Formula	C8H10FN3O3S
Molecular Weight	247.25 g/mol
Synonyms	4-Amino-5-fluoro-1-[(2R,5S)-2-(hydroxymethyl)-1,3-oxathiolan-5-yl]-1,2-dihydropyrimidin-2-one; FTC Impurity 16; Emtricitabine Related Compound 16; 5-Fluoro-1-[(2R,5S)-2-(hydroxymethyl)-1,3-oxathiolan-5-yl]cytosine Impurity; (-)-FTC Impurity 16
EINECS	Contact for details

Quality Control

Every batch of Emtricitabine Impurity 16 is manufactured and analyzed under strict quality systems. Our products undergo rigorous quality testing to ensure compliance with industry standards. Certificates of Analysis (COA) are available upon request, providing detailed results for identity, purity, and impurity profile as per current pharmacopeial expectations.

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 under inert conditions or in a desiccator to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown 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.