Description

Lamivudine Impurity 1 is a specified impurity and reference standard used in the quality control of the active pharmaceutical ingredient (API) Lamivudine. This compound is critical for ensuring the purity, safety, and efficacy of Lamivudine-based pharmaceutical formulations. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for research, method development, and compliance testing.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Lamivudine API and finished drug products.
• Analytical Method Development & Validation: Essential for developing and validating chromatographic methods, such as HPLC and UPLC, to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): Serves as a system suitability standard in routine batch release testing to ensure product specifications are met.
• Regulatory Compliance & Filings: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing impurity characterization data for drug master files (DMFs).
• Stability Studies: Employed to track the formation of degradation products in Lamivudine formulations under various stress conditions.
• Research & Development: Used in synthetic chemistry research to study the formation pathways and properties of this specific impurity.

Basic Information

Product Name	Lamivudine Impurity 1
CAS No.	147126-80-5
Molecular Formula	C8H11N3O3S
Molecular Weight	229.26 g/mol
Synonyms	Lamivudine Related Compound A; (2R,5S)-5-(Cytosin-1-yl)-1,3-oxathiolane-2-carboxamide; 1,3-Oxathiolane-2-carboxamide, 5-(4-amino-2-oxo-1(2H)-pyrimidinyl)-, (2R,5S)-; Lamivudine EP Impurity A; Lamivudine USP Related Compound A; Lamivudine Process Impurity; (-)-2'-Deoxy-3'-thiacytidine Impurity 1; 3TC Impurity 1
EINECS	Contact for details

Quality Control

Our Lamivudine Impurity 1 is manufactured and tested under strict quality management systems. Each batch is characterized using advanced analytical techniques, including HPLC, NMR, and MS, to ensure high purity and accurate identification. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing purity, impurity profile, and analytical results. Our quality standards align with ICH guidelines for impurities in new drug substances.

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 material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 0.5%
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.