Description

Emtricitabine Impurity 9 is a specified organic compound used as a critical reference standard in the pharmaceutical development and quality control of the antiretroviral drug Emtricitabine. This impurity is essential for ensuring the purity, safety, and efficacy of the final Active Pharmaceutical Ingredient (API) by providing a benchmark for analytical methods. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method validation, stability studies, and batch release testing.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material for the identification and quantification of Emtricitabine-related impurities in API and finished drug products.
• Analytical Method Development & Validation: Used to develop, optimize, and validate chromatographic methods (HPLC, UPLC) for impurity profiling.
• Quality Control & Batch Release: A critical component in the routine QC testing of Emtricitabine API to ensure compliance with pharmacopeial limits (e.g., USP, EP, ICH guidelines).
• Stability Studies: Employed to monitor the formation of this specific impurity over time under various stress conditions (heat, light, humidity) to establish product shelf life.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to demonstrate thorough impurity characterization and control strategies.
• Research & Development: Used in synthetic chemistry research to study degradation pathways and to synthesize purer batches of the main API.

Basic Information

Product Name	Emtricitabine Impurity 9
CAS No.	20752-33-4
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 9; Emtricitabine Related Compound 9; 5-Fluoro-1-[(2R,5S)-2-(hydroxymethyl)-1,3-oxathiolan-5-yl]cytosine; (-)-2'-Deoxy-5-fluoro-3'-thiacytidine Impurity 9
EINECS	Contact for details

Quality Control

Every batch of Emtricitabine Impurity 9 is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC for purity and identity confirmation (IR, NMR), to ensure compliance with high-purity reference standard requirements. A comprehensive Certificate of Analysis (COA) is provided with each batch, detailing purity, assay, and impurity profiles. We support compliance with ICH Q3A/B and pharmacopeial 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 (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider storing under inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 98.0%
Assay	97.0% - 103.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Single Unknown Impurity (HPLC)	≤ 0.5%
Total Impurities (HPLC)	≤ 2.0%

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