Description

Lamivudine Impurity 12 is a characterized impurity reference standard used in the analytical profiling of the antiviral drug Lamivudine. This compound is critical for ensuring the safety, efficacy, and regulatory compliance of pharmaceutical products by enabling accurate identification and quantification of process-related impurities. It is an essential material for quality control laboratories in the pharmaceutical industry, particularly for manufacturers and analytical service providers focused on antiretroviral drugs.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of Lamivudine Impurity 12 in active pharmaceutical ingredients (API) and finished drug products.
• Method Development and Validation: Critical for developing, validating, and transferring analytical methods, including HPLC, UPLC, and LC-MS, in compliance with ICH Q2(R1) guidelines.
• Stability Studies: Used to monitor the formation and levels of this specific impurity during forced degradation and long-term stability testing of Lamivudine formulations.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing definitive impurity characterization data for Drug Master Files (DMFs) and Common Technical Documents (CTDs).
• Quality Control & Batch Release: Serves as a system suitability standard in routine QC testing to ensure the purity and consistency of Lamivudine API batches against established specifications.
• Research and Development: Facilitates impurity fate and tolerance studies during process chemistry development and optimization for Lamivudine synthesis.

Basic Information

Product Name	Lamivudine Impurity 12
CAS No.	1638744-50-9
Molecular Formula	C8H11N3O3S
Molecular Weight	229.26 g/mol
Synonyms	Lamivudine Related Compound 12; 4-Amino-1-[(2R,5S)-2-(hydroxymethyl)-1,3-oxathiolan-5-yl]-2(1H)-pyrimidinone; (2R,5S)-2-(Hydroxymethyl)-5-(4-amino-2-oxopyrimidin-1(2H)-yl)-1,3-oxathiolane; 1-((2R,5S)-2-(Hydroxymethyl)-1,3-oxathiolan-5-yl)-4-aminopyrimidin-2(1H)-one; Lamivudine EP Impurity I; Lamivudine USP Related Compound A (Isomer); 1,3-Oxathiolane, 2-(hydroxymethyl)-5-(4-amino-2-oxo-1(2H)-pyrimidinyl)-, (2R-cis)-
EINECS	Contact for details

Quality Control

Every batch of Lamivudine Impurity 12 is produced and analyzed under strict quality management systems. The material undergoes rigorous identity confirmation, purity assay, and impurity profiling using advanced chromatographic and spectroscopic techniques to ensure it meets the exacting standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, related substances, and identification. Our quality protocols are designed to support compliance with cGMP and relevant pharmacopeial guidelines (USP, EP).

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C, in a dry environment. This material is hygroscopic (moisture-sensitive); the container must be kept tightly sealed and stored in a desiccated area to prevent absorption of moisture.

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)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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