Description

Emtricitabine Impurity 19 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. The use of this well-characterized impurity standard is essential for meeting stringent pharmacopeial requirements and maintaining batch-to-batch consistency in drug production.

Application

• Primary use as a certified reference standard for the identification and quantification of Emtricitabine Impurity 19 in API and finished drug products.
• Essential for pharmaceutical research and development (R&D) during process optimization and stability studies.
• Critical component in analytical method development and validation (HPLC, LC-MS) for impurity control strategies.
• Used in quality control (QC) laboratories for routine batch release testing of Emtricitabine API.
• Serves as a system suitability standard in chromatographic assays to ensure analytical instrument performance.
• Supports regulatory filings (e.g., ANDA, NDA) by providing data for impurity qualification and ICH guideline compliance (Q3A(R2), Q3B(R2)).
• Valuable for academic and institutional research studying the degradation pathways and metabolism of Emtricitabine.

Basic Information

Product Name	Emtricitabine Impurity 19
CAS No.	1962114-95-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Emtricitabine Related Compound 19; FTC Impurity 19; 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; Emtricitabine EP Impurity I; Emtricitabine USP Impurity; (-)-FTC Impurity; Oxathiolane Cytosine Derivative
EINECS	Contact for details

Quality Control

Every batch of Emtricitabine Impurity 19 is manufactured and controlled under a strict quality management system. The product undergoes rigorous analytical testing, including HPLC for purity and identity confirmation (IR, NMR), to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. Our quality commitment aligns with cGMP principles and supports compliance with ICH, USP, and EP guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed in a dry environment to prevent moisture absorption. For long-term storage, consider desiccants or inert atmosphere conditions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown 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.