Description

Lamivudine Impurity 1 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for the quality control and regulatory compliance of Lamivudine, a key active pharmaceutical ingredient (API) in antiviral medications. 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 API and finished drug products.
• Analytical Method Development & Validation: Serves as a critical standard for developing and validating HPLC, UPLC, or GC methods in quality control laboratories.
• Stability Studies: Employed to monitor the formation of degradation products in Lamivudine formulations under various stress conditions.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submissions (e.g., for FDA, EMA) that require detailed impurity characterization and control strategies.
• Research & Development: Used in R&D to study the synthesis pathways, degradation mechanisms, and metabolic pathways related to Lamivudine.
• Quality Assurance/Quality Control (QA/QC): Acts as a primary standard for routine batch release testing to ensure product safety and efficacy.

Basic Information

Product Name	Lamivudine Impurity 1
CAS No.	1235712-40-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Lamivudine Related Compound 1; Lamivudine EP Impurity 1; Lamivudine USP Impurity; 3TC Impurity 1; (-)-2',3'-Dideoxy-3'-thiacytidine Impurity; 4-Amino-1-[(2R,5S)-2-(hydroxymethyl)-1,3-oxathiolan-5-yl]-2(1H)-pyrimidinone Impurity; Lamivudine Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Lamivudine Impurity 1 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 pharmacopeial standards (e.g., USP, EP) and customer-specific requirements. A comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity data is provided with each shipment.

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. For long-term storage, consider desiccants or 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)	Individual impurity: ≤ 1.0% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH guidelines

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