Description

Abacavir Impurity F is a specified impurity associated with the active pharmaceutical ingredient (API) Abacavir, an antiretroviral medication. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development, validation, and quality control processes. It is primarily used by pharmaceutical manufacturers, contract research organizations (CROs), and quality control laboratories to ensure the purity, safety, and regulatory compliance of Abacavir-based drug products.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Abacavir API and finished dosage forms.
• Analytical Method Development: Essential for developing and optimizing chromatographic methods, such as HPLC and UPLC, for impurity profiling.
• Quality Control & Assurance: Employed in routine batch testing to monitor impurity levels and ensure they remain within ICH (Q3B) specified limits.
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity characterization data for drug master files (DMFs).
• Stability Studies: Used to track the formation of degradation products in Abacavir formulations under various stress conditions.
• Research & Synthesis: Serves as an intermediate or starting material in chemical synthesis for further pharmaceutical research.

Basic Information

Item	Details
Product Name	Abacavir Impurity F
CAS No.	1443421-68-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Abacavir Related Compound F; Abacavir EP Impurity F; Abacavir USP Impurity F; (1S,4R)-4-[2-Amino-6-(cyclopropylamino)-9H-purin-9-yl]-2-cyclopentene-1-methanol Impurity; Abacavir Degradant F; Abacavir Process Impurity F
EINECS	Contact for details

Quality Control

Our Abacavir Impurity F is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC purity analysis and spectroscopic identification (NMR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing purity, assay, and impurity profile. Our quality commitment aligns with the principles of GMP and ICH guidelines.

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 product 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 solid
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity ≤ 1.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%

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