Description

5'-Epi-Lamivudine is a stereoisomer of the well-known nucleoside reverse transcriptase inhibitor Lamivudine, identified by CAS number 136846-20-3. This compound is a critical pharmaceutical intermediate and reference standard used in the research, development, and quality control of antiviral medications. It is primarily required by pharmaceutical R&D laboratories, API manufacturers, and analytical service providers for impurity profiling, method validation, and synthesis pathway studies.

Application

• Pharmaceutical Impurity Standard: Serves as a certified reference material (CRM) for the identification and quantification of the 5'-epi impurity in Lamivudine active pharmaceutical ingredient (API) batches.
• Process Research & Development: Used in studying stereoselective synthesis routes and optimizing manufacturing processes for nucleoside analogs.
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, or LC-MS methods for impurity assays in compliance with ICH guidelines.
• Metabolism and Pharmacokinetic Studies: Employed as a metabolite analog in preclinical research to understand drug disposition and stereochemical effects.
• Quality Control & Assurance: A critical component in the quality control laboratories of API manufacturers to ensure product purity and regulatory compliance.
• Academic & Institutional Research: Used in universities and research institutes for fundamental studies in medicinal chemistry, virology, and nucleoside chemistry.

Basic Information

Product Name	5'-Epi-Lamivudine
CAS No.	136846-20-3
Molecular Formula	C8H11N3O3S
Molecular Weight	229.26 g/mol
Synonyms	(-)-2',3'-Dideoxy-3'-thiacytidine 5'-Epimer; BCH-189 5'-Epimer; 5'-Epilamivudine; (2R,5S)-4-Amino-1-[(2R,5S)-2-(hydroxymethyl)-1,3-oxathiolan-5-yl]-1,2-dihydropyrimidin-2-one; Lamivudine 5'-Epimer; 3TC 5'-Epimer; GR-109714X (5'-Epimer); Oxathiolanylcytosine Epimer
EINECS	Contact for details

Quality Control

Our 5'-Epi-Lamivudine is produced under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC purity assay, chiral purity determination, and structural confirmation via spectroscopic methods. We provide a detailed Certificate of Analysis (COA) with each shipment, which includes batch-specific data on purity, impurities, and residual solvents. Our quality standards are designed to meet the rigorous demands of pharmaceutical reference material applications.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and must be kept under anhydrous conditions. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Chiral Purity (Chiral HPLC)	≥ 99.0%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Heavy Metals	< 20 ppm

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