Description

Lamivudine Impurity 13 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient Lamivudine, an essential antiviral medication. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling studies.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specific impurities in Lamivudine drug substance and finished products.
• Analytical Method Development & Validation: Serves as a critical standard for developing and validating HPLC, UPLC, or LC-MS methods to monitor impurity levels.
• Quality Control & Assurance (QC/QA): Employed in routine quality control testing to ensure Lamivudine batches meet stringent pharmacopeial specifications (e.g., USP, EP, ICH Q3A/B).
• Stability Studies: Used to track the formation and growth of this specific impurity during forced degradation and long-term stability studies of Lamivudine formulations.
• Regulatory Submissions: Essential for preparing regulatory documentation (e.g., for FDA, EMA) to demonstrate comprehensive impurity control strategies.
• Research & Development: Utilized in R&D laboratories for studying the degradation pathways and chemistry of Lamivudine.

Basic Information

Product Name	Lamivudine Impurity 13
CAS No.	2250242-24-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Lamivudine Related Compound 13; Lamivudine EP Impurity 13; Lamivudine USP Impurity 13; Lamivudine Degradation Product 13; 3TC Impurity 13; (2R,5S)-5-Azido-1-(2-hydroxymethyl-1,3-oxathiolan-5-yl)cytosine (tentative); 2250242-24-9
EINECS	Contact for details

Quality Control

Every batch of Lamivudine Impurity 13 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing, including advanced chromatographic and spectroscopic techniques, to ensure compliance with industry standards and customer specifications. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing purity, identity, and impurity profiles.

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. Keep the container in a dry, cool, and well-ventilated area. Handle and store in accordance with good laboratory practices.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Meets customer requirements
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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