Description

Emtricitabine Impurity 28 is a high-purity chemical reference standard used for analytical and research purposes in pharmaceutical development. This compound is critical for ensuring the quality, safety, and efficacy of the antiretroviral drug Emtricitabine by serving as a benchmark for impurity identification and quantification. It is an essential material for analytical chemists and quality control laboratories in pharmaceutical companies and contract research organizations (CROs) focused on antiviral drug manufacturing and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the quality control of Emtricitabine Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Used to develop, optimize, and validate HPLC, UPLC, or LC-MS methods for impurity profiling.
• Stability Studies: Employed to monitor the formation and levels of this specific impurity during forced degradation and long-term stability testing of drug formulations.
• Regulatory Compliance & Filing: Critical for preparing regulatory submission documents (e.g., for FDA, EMA) that require detailed impurity characterization and control strategies.
• Research & Development: Used in R&D laboratories to study the degradation pathways and chemical behavior of Emtricitabine.
• Quality Assurance/Control (QA/QC): Serves as a system suitability standard and for routine batch release testing in QC laboratories to ensure impurity limits meet pharmacopeial specifications.

Basic Information

Product Name	Emtricitabine Impurity 28
CAS No.	1238210-14-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	FTC Impurity 28; Emtricitabine Related Compound 28; 5-Fluoro-1-[(2R,5S)-2-(hydroxymethyl)-1,3-oxathiolan-5-yl]cytosine Impurity; 1,3-Oxathiolane, 2-(hydroxymethyl)-5-(4-amino-5-fluoro-2-oxo-1(2H)-pyrimidinyl)-, (2R,5S)-; (2R,5S)-5-(4-Amino-5-fluoro-2-oxopyrimidin-1(2H)-yl)-1,3-oxathiolane-2-carbaldehyde; A potential oxidative degradation product of Emtricitabine.
EINECS	Contact for details

Quality Control

Every batch of Emtricitabine Impurity 28 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity testing using advanced chromatographic (HPLC/UPLC) and spectroscopic (NMR, MS) techniques to ensure compliance with industry standards for reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

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 and protected from moisture.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 2.0%

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