Description

trans-Abacavir-D4 Hydrochloride CAS NO 1346605-40-0 is a high-purity, stable isotope-labeled analog of the antiretroviral drug Abacavir, where four hydrogen atoms are replaced by deuterium at specified positions. This compound is an essential internal standard for the accurate quantification and pharmacokinetic profiling of Abacavir in biological matrices using advanced analytical techniques like LC-MS/MS. It is primarily required by pharmaceutical R&D laboratories, contract research organizations (CROs), and analytical testing facilities engaged in drug development, bioequivalence studies, and therapeutic drug monitoring for HIV treatment.

Application

• Internal Standard for Bioanalysis: Serves as a critical reference compound in the quantitative analysis of Abacavir in plasma, serum, and other biological samples via mass spectrometry.
• Pharmacokinetic and Metabolism Studies: Enables precise tracking of drug absorption, distribution, metabolism, and excretion (ADME) in preclinical and clinical research.
• Method Development and Validation: Used to develop, optimize, and validate robust analytical methods in compliance with GLP and FDA/EMA guidelines.
• Drug Impurity Profiling: Aids in the identification and quantification of related substances and degradants in drug substance and product testing.
• Stable Isotope Dilution Assays: Provides high accuracy and minimizes matrix effects in complex sample analyses for reliable data.
• Quality Control in Manufacturing: Supports in-process testing and final release testing of Abacavir active pharmaceutical ingredients (APIs) and formulations.

Basic Information

Product Name	trans-Abacavir-D4 Hydrochloride
CAS No.	1346605-40-0
Molecular Formula	C14H14D4N6O·HCl
Molecular Weight	328.80 g/mol (for free base C14H14D4N6O)
Synonyms	Abacavir-d4 Hydrochloride; (1S,4R)-4-[2-Amino-6-(cyclopropylamino)-9H-purin-9-yl]-2-cyclopentene-1-methanol-d4 Hydrochloride; [(1S,4R)-4-[2-Amino-6-(cyclopropylamino)purin-9-yl]cyclopent-2-en-1-yl]methanol-d4 Hydrochloride; Deuterated Abacavir HCl; Abacavir Internal Standard; ABC-d4 HCl; Ziagen-d4 Hydrochloride
EINECS	Contact for details

Quality Control

Our trans-Abacavir-D4 Hydrochloride is manufactured under strict quality systems to ensure the highest standards of purity and isotopic enrichment, suitable for sensitive analytical applications. Each batch is supported by a comprehensive Certificate of Analysis (COA) detailing key parameters such as chemical purity, isotopic purity (D-enrichment), and residual solvent content. We adhere to relevant industry guidelines to support your regulatory submissions.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Isotopic Purity (D-enrichment)	≥ 98.0 atom % D
Chemical Purity (by NMR)	Conforms
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH guidelines

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