Description

Emtricitabine Impurity 18 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 ensuring the safety and efficacy of antiviral drug formulations by enabling the accurate identification and quantification of process-related impurities. It is an essential material for pharmaceutical R&D laboratories, quality assurance departments, and regulatory bodies involved in the development and manufacture of antiretroviral medications.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of Emtricitabine Impurity 18 in API and finished drug product testing.
• Method Development and Validation: Critical for developing, optimizing, and validating analytical methods such as HPLC, UPLC, and LC-MS for impurity profiling.
• Quality Control & Assurance (QC/QA): Used in routine batch release testing to monitor and control impurity levels, ensuring compliance with ICH Q3A/B guidelines.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing characterized impurity data for drug master files (DMFs) and investigational new drug (IND) applications.
• Stability Studies: Employed to track the formation of this specific impurity under various stress conditions (heat, light, humidity) to establish product shelf-life.
• Process Chemistry Research: Aids chemists in understanding and optimizing the Emtricitabine synthesis pathway to minimize the formation of this impurity.

Basic Information

Product Name	Emtricitabine Impurity 18
CAS No.	1962115-01-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Emtricitabine Related Compound 18; FTC Impurity 18; 5-Fluoro-1-[(2R,5S)-2-(hydroxymethyl)-1,3-oxathiolan-5-yl]cytosine Impurity; Emtricitabine EP Impurity I; Emtricitabine Process Impurity; Coviracil Impurity; (-)-FTC Impurity 18
EINECS	Contact for details

Quality Control

Every batch of Emtricitabine Impurity 18 is manufactured and analyzed under strict quality management systems. The product undergoes comprehensive characterization and purity verification using advanced techniques including HPLC, GC, MS, and NMR to ensure it meets the stringent requirements for a pharmaceutical reference standard. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment, supporting compliance with cGMP and relevant pharmacopeial 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. The material should be kept in a dry environment and protected from moisture. For long-term storage, consider storing under inert atmosphere.

Specification

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

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