Description

Abacavir Related Compound D is a high-purity reference standard and pharmaceutical intermediate of critical importance in the development and quality control of antiviral medications. This compound serves as a key impurity marker, essential for ensuring the safety, efficacy, and regulatory compliance of the active pharmaceutical ingredient (API) Abacavir sulfate. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions engaged in the synthesis, validation, and batch release of antiretroviral drugs.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Abacavir sulfate API and finished dosage forms according to ICH guidelines.
• Analytical Method Development & Validation: Critical for developing, calibrating, and validating HPLC, UPLC, or LC-MS methods for impurity profiling.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing to monitor and control the levels of specified impurities, ensuring product meets pharmacopeial standards (USP, EP).
• Process Chemistry Research: Used in synthetic route development and optimization to understand and minimize the formation of this related compound during API manufacturing.
• Regulatory Submissions: Essential for compiling impurity data in regulatory filings (e.g., FDA, EMA) for drug master files (DMFs) and new drug applications (NDAs).
• Stability Studies: Used as a marker to track degradation products in long-term and accelerated stability testing of drug substances and products.

Basic Information

Product Name	Abacavir Related Compound D
CAS No.	1443421-69-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Abacavir Impurity D; Abacavir Sulfate Related Compound D; Abacavir EP Impurity D; Abacavir USP Related Compound D; (1S,4R)-4-[2-Amino-6-(cyclopropylamino)-9H-purin-9-yl]-2-cyclopentene-1-methanol (Related Compound of Abacavir); Cyclopropyl analog of Abacavir related substance; Abacavir Process Impurity.
EINECS	Contact for details

Quality Control

Every batch of Abacavir Related Compound D is manufactured and controlled under a strict quality management system. Our products undergo rigorous identity, purity, and assay testing using validated analytical methods (e.g., HPLC, NMR, MS) to ensure compliance with pharmacopeial and customer-specific standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment to support your regulatory and quality requirements.

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 must be kept under inert conditions or in a desiccator after opening to prevent degradation. For long-term storage, consider storing at 2-8°C.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (NMR)	Conforms
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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