Description

Lamivudine Ep Impurity A is a specified impurity and reference standard used in the analytical profiling of the active pharmaceutical ingredient Lamivudine. This compound is critical for ensuring the quality, safety, and efficacy of Lamivudine-based antiviral medications by providing a benchmark for impurity identification and quantification. It is an essential material for pharmaceutical manufacturers, analytical laboratories, and regulatory bodies engaged in research, development, and quality control of antiretroviral drugs.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Lamivudine Ep Impurity A in drug substances and products.
• Analytical Method Development & Validation: Critical for developing, validating, and transferring HPLC, UPLC, or LC-MS methods in quality control laboratories.
• Stability Studies & Degradation Profiling: Used to monitor the formation of this specific impurity under various stress conditions (heat, light, humidity) as per ICH guidelines.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., ANDA, NDA) by providing impurity data required by pharmacopoeial standards (USP, EP, ICH Q3A/B).
• Quality Control Testing: Serves as a system suitability and calibration standard in routine batch release testing of Lamivudine API and finished dosage forms.
• Research & Development: Used in synthetic chemistry research to study impurity formation pathways and to develop purification processes.

Basic Information

Product Name	Lamivudine Ep Impurity A
CAS No.	1822826-02-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Lamivudine Impurity A; Lamivudine Related Compound A; (2R,5S)-5-Azido-1-(2-hydroxymethyl-1,3-oxathiolan-5-yl)cytosine; 5-Azido Lamivudine; European Pharmacopoeia Lamivudine Impurity A; EP Impurity A of Lamivudine; Lamivudine Azido Impurity
EINECS	Contact for details

Quality Control

Our Lamivudine Ep Impurity A is manufactured and handled under strict quality management systems. Each batch undergoes comprehensive analytical testing, including chromatographic purity (HPLC), identity confirmation (IR, MS), and water content determination, to ensure it meets the stringent requirements for a pharmaceutical reference standard. Certificates of Analysis (COA) with detailed batch-specific results are provided and traceable to primary standards where applicable.

Storage

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

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Water Content (KF)	≤ 5.0% w/w

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