Description

Emtricitabine Impurity 25 CAS NO 1773498-61-5 is a high-purity chemical reference standard used for the analytical profiling and quality control of the antiretroviral drug Emtricitabine. This impurity is critical for pharmaceutical manufacturers and research laboratories to ensure drug safety, efficacy, and regulatory compliance by accurately identifying and quantifying related substances. It is an essential material for method development, validation, and stability studies within the pharmaceutical and analytical chemistry sectors.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the quality control of Emtricitabine Active Pharmaceutical Ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Critical for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods to detect and quantify impurities.
• Stability Studies & Forced Degradation: Used to identify and monitor degradation products formed under various stress conditions (e.g., heat, light, humidity) to establish drug shelf-life.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing definitive characterization data for impurity profiles in drug submissions.
• Pharmaceutical Research: Aids in synthetic route optimization and process chemistry research to understand and minimize impurity formation during manufacturing.
• Quality Assurance/Quality Control (QA/QC) Laboratories: Serves as a system suitability and identification standard in routine batch release testing.

Basic Information

Product Name	Emtricitabine Impurity 25
CAS No.	1773498-61-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Emtricitabine Related Compound 25; FTC Impurity 25; 4-Amino-5-fluoro-1-[(2R,5S)-2-(hydroxymethyl)-1,3-oxathiolan-5-yl]-1,2-dihydropyrimidin-2-one; Emtricitabine EP Impurity I; Emtricitabine USP Impurity; 5-Fluoro-1-[(2R,5S)-2-(hydroxymethyl)-1,3-oxathiolan-5-yl]cytosine Impurity
EINECS	Contact for details

Quality Control

Our Emtricitabine Impurity 25 is manufactured and handled under strict quality management systems. Each batch undergoes comprehensive analytical characterization using advanced techniques such as HPLC, GC, NMR, and MS to confirm identity and purity. We provide a detailed Certificate of Analysis (COA) with each shipment, which includes batch-specific data on purity, impurities, and residual solvents. Our quality standards are designed to meet the rigorous requirements of pharmaceutical reference material applications.

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 COA. The material should be kept in a dry environment to prevent moisture uptake. For long-term storage, consider storing under inert atmosphere.

Specification

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

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