Description

Abacavir Impurity E is a specified impurity of the antiretroviral drug Abacavir Sulfate, used in the treatment of HIV-1 infection. This high-purity reference standard is critical for analytical method development, validation, and quality control in pharmaceutical manufacturing to ensure drug safety and efficacy. It is an essential material for research and development laboratories, quality assurance departments, and regulatory bodies focused on impurity profiling and compliance with ICH guidelines.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Abacavir Sulfate active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Used to develop, optimize, and validate chromatographic methods (e.g., HPLC, UPLC) for impurity separation and detection.
• Quality Control & Assurance (QC/QA): Serves as a system suitability standard and for routine batch release testing in pharmaceutical QC laboratories to monitor impurity levels against regulatory thresholds.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission dossiers (e.g., for FDA, EMA) that require detailed impurity characterization and control strategies.
• Stability Studies: Employed in forced degradation and long-term stability studies of Abacavir formulations to track the formation and growth of this specific impurity over time.
• Research & Development: Used in synthetic chemistry R&D to understand the formation pathway of this impurity and to develop purification processes to minimize its presence.

Basic Information

Item	Details
Product Name	Abacavir Impurity E
CAS No.	208762-35-0
Molecular Formula	C14H18N6O
Molecular Weight	286.34 g/mol
Synonyms	(1S,4R)-4-[2-Amino-6-(cyclopropylamino)-9H-purin-9-yl]-2-cyclopentene-1-methanol; Abacavir Cyclopropyl Analog; Abacavir Related Compound E; Abacavir EP Impurity E; Abacavir USP Related Compound E; (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 E is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity analysis, and impurity profiling using advanced techniques like HPLC, GC, and NMR to ensure compliance with pharmaceutical reference standard requirements. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, related substances, residual solvents, and other critical parameters.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent absorption of moisture. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0%

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