Description

Emtricitabine Impurity 29 CAS NO 1994304-22-1 is a high-purity chemical reference standard used for the analytical profiling and quality control of the active pharmaceutical ingredient (API) Emtricitabine. This impurity is critical for pharmaceutical manufacturers and analytical laboratories to ensure drug safety, efficacy, and regulatory compliance by accurately identifying and quantifying related substances. It is essential for research and development, method validation, and stability studies within the pharmaceutical and biotechnology sectors.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of Emtricitabine-related impurities in drug substances and products.
• Analytical Method Development & Validation: Crucial for developing, validating, and verifying HPLC, UPLC, and LC-MS methods in quality control laboratories.
• Stability Indicating Studies: Used to monitor the formation of degradation products in Emtricitabine formulations under various stress conditions (e.g., heat, light, humidity).
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., ANDA, NDA) by providing impurity data required by ICH Q3A(R2) and Q3B(R2) guidelines.
• Process Chemistry Research: Aids in the optimization of Emtricitabine synthesis by identifying and tracking process-related impurities.
• Pharmacopoeial Testing: Employed in testing to meet the specifications of pharmacopoeias such as USP, EP, and BP for Emtricitabine API.

Basic Information

Product Name	Emtricitabine Impurity 29
CAS No.	1994304-22-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Emtricitabine Related Compound 29; FTC Impurity 29; Emtricitabine EP Impurity K; 5-Fluoro-1-[(2R,5S)-2-(hydroxymethyl)-1,3-oxathiolan-5-yl]cytosine Impurity; 4-Amino-5-fluoro-1-[(2R,5S)-2-(hydroxymethyl)-1,3-oxathiolan-5-yl]pyrimidin-2(1H)-one Impurity; (-)-FTC Impurity 29; Coviracil Impurity 29
EINECS	Contact for details

Quality Control

Every batch of Emtricitabine Impurity 29 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity analysis, and impurity profiling using advanced chromatographic and spectroscopic techniques (e.g., HPLC, GC, NMR, MS) to ensure it meets the stringent requirements for a pharmaceutical reference standard. 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 handled under appropriate laboratory conditions to maintain stability.

Specification

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

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