Description

Emtricitabine Impurity 22 is a characterized impurity and reference standard used in the analytical profiling of the antiretroviral drug Emtricitabine. This compound is critical for ensuring the safety, efficacy, and regulatory compliance of pharmaceutical products by enabling precise identification and quantification of related substances. It is primarily required by pharmaceutical manufacturers, quality control laboratories, and research institutions involved in the development and production of HIV/AIDS therapeutics.

Application

• Pharmaceutical Reference Standard: Serves as a certified standard for the identification and quantification of Emtricitabine Impurity 22 in active pharmaceutical ingredients (APIs) and finished drug products.
• Method Development and Validation: Essential for developing, optimizing, and validating analytical methods, particularly High-Performance Liquid Chromatography (HPLC) and LC-MS.
• Quality Control & Assurance: Used in routine batch testing to monitor impurity levels and ensure they remain within International Council for Harmonisation (ICH) guidelines.
• Regulatory Submissions: Supports regulatory filings (e.g., for FDA, EMA) by providing necessary impurity characterization data for drug master files (DMFs) and new drug applications (NDAs).
• Stability Studies: Employed to track the formation of this impurity over time under various stress conditions, supporting shelf-life determination.
• Research & Development: Facilitates process chemistry research to understand impurity formation pathways and optimize synthesis routes for purer Emtricitabine API.

Basic Information

Product Name	Emtricitabine Impurity 22
CAS No.	147027-01-8
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 Related Compound 22; Emtricitabine EP Impurity G; Emtricitabine USP Related Compound G; 5-Fluoro-1-[(2R,5S)-2-(hydroxymethyl)-1,3-oxathiolan-5-yl]cytosine Impurity; (-)-FTC Impurity 22; (2R,5S)-5-(4-Amino-5-fluoro-2-oxopyrimidin-1(2H)-yl)-1,3-oxathiolane-2-methanol
EINECS	Contact for details

Quality Control

Our Emtricitabine Impurity 22 is manufactured and handled under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, NMR and MS for structural confirmation, and residual solvent analysis. We provide a comprehensive Certificate of Analysis (COA) with each shipment, detailing batch-specific results. Our standards are suitable for use in methods validated per ICH Q2(R1), USP <621>, and EP 2.2.46 guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C (59-77°F), in a dry environment. The material is hygroscopic (moisture-sensitive); ensure the container is sealed after each use to prevent absorption of atmospheric moisture.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any single unknown impurity ≤ 1.0%
Water Content (KF)	≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C

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