Description

Abacavir Impurity 1 is a designated pharmaceutical reference standard used for the identification, qualification, and quantification of process-related impurities in the active pharmaceutical ingredient (API) Abacavir. This high-purity compound is critical for ensuring the safety, efficacy, and regulatory compliance of antiviral drug formulations. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for rigorous quality control and research and development activities.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for analytical method development, validation, and routine quality control testing of Abacavir API and finished dosage forms.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission documents (e.g., for FDA, EMA) to demonstrate comprehensive impurity profiling and control strategies.
• Stability Studies: Used to monitor the formation and levels of this specific impurity during forced degradation and long-term stability studies of Abacavir products.
• Process Chemistry Research: Employed in research to understand and optimize the Abacavir synthesis pathway, helping to minimize the formation of this impurity.
• Analytical Laboratory Calibration: Acts as a primary calibrant for HPLC, UPLC, and LC-MS systems to ensure accurate impurity quantification.
• Pharmacopoeial Testing: Supports testing in compliance with pharmacopoeial monographs (e.g., USP, EP) that specify limits for known and unknown impurities.

Basic Information

Item	Details
Product Name	Abacavir Impurity 1
CAS No.	178327-20-3
Molecular Formula	C₁₄H₁₈N₆O
Molecular Weight	286.33 g/mol
Synonyms	(1S,4R)-4-[2-Amino-6-(cyclopropylamino)-9H-purin-9-yl]-2-cyclopentene-1-methanol; Abacavir Related Compound; Abacavir EP Impurity; Abacavir USP Impurity; Cyclopropyl analog of Abacavir; (1S,4R)-4-[2-Amino-6-(cyclopropylamino)-9H-purin-9-yl]cyclopent-2-en-1-ylmethanol
EINECS	Contact for details

Quality Control

Every batch of Abacavir Impurity 1 is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC purity analysis and structural confirmation (NMR, MS), to ensure they meet the exacting standards required for pharmaceutical impurity standards. A comprehensive Certificate of Analysis (COA) detailing identity, purity, and impurity profile is provided with each shipment to support your regulatory and quality assurance needs.

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 compound is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity.

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 unknown 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.