Description

Emtricitabine Impurity 12 is a high-purity reference standard used for the analytical characterization and quality control of the active pharmaceutical ingredient (API) Emtricitabine. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure product safety, efficacy, and regulatory compliance by accurately identifying and quantifying related substances. It is an essential material for research and development, method validation, and stability studies in the production of antiviral medications.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of impurities in Emtricitabine API and finished drug products.
• Analytical Method Development & Validation: Used to develop, optimize, and validate chromatographic methods (e.g., HPLC, UPLC) for impurity profiling.
• Quality Control & Assurance (QC/QA): Serves as a system suitability and calibration standard in routine quality control testing to monitor batch-to-batch consistency.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., ANDA, NDA) by providing definitive impurity characterization data for health authorities like the FDA and EMA.
• Stability Studies: Employed to track the formation and levels of this specific impurity under various stress conditions (heat, light, humidity) to establish product shelf-life.
• Research & Development: Used in synthetic chemistry research to study impurity formation pathways and to develop purification processes for the API.

Basic Information

Product Name	Emtricitabine Impurity 12
CAS No.	1055312-45-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	FTC Impurity 12; Emtricitabine Related Compound 12; 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 Impurity; (-)-FTC Impurity 12; Emtricitabine EP Impurity I; Emtricitabine Process Impurity
EINECS	Contact for details

Quality Control

Our Emtricitabine Impurity 12 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including advanced chromatographic and spectroscopic techniques, to ensure identity, purity, and consistency. A comprehensive Certificate of Analysis (COA) is provided with each lot, detailing all test results against stringent in-house specifications. Our quality commitment supports compliance with ICH Q3A, Q3B guidelines and meets the needs of cGMP manufacturing environments.

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. Keep the container in a dry, cool, and well-ventilated area. For long-term storage, consider storing under inert atmosphere to ensure stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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