Description

Ganciclovir-D5 is a deuterium-labeled analog of the antiviral drug Ganciclovir, specifically designed for use as an internal standard in analytical chemistry. This high-purity stable isotope-labeled compound is essential for ensuring the accuracy and reliability of quantitative analyses, particularly in pharmacokinetic and bioequivalence studies. It is primarily utilized by pharmaceutical research and development laboratories, contract research organizations (CROs), and quality control departments requiring precise measurement of Ganciclovir in complex biological matrices.

Application

• Internal Standard for LC-MS/MS: Critical for the accurate quantification of Ganciclovir in bioanalytical methods, including plasma, serum, and tissue samples.
• Drug Metabolism and Pharmacokinetics (DMPK): Used in studies to understand the absorption, distribution, metabolism, and excretion (ADME) profile of Ganciclovir.
• Therapeutic Drug Monitoring (TDM): Enables precise measurement of drug concentrations in patient samples to optimize dosing regimens and ensure therapeutic efficacy while minimizing toxicity.
• Pharmaceutical Quality Control: Supports method development and validation for the assay of Ganciclovir in active pharmaceutical ingredients (APIs) and finished drug products.
• Clinical Research: Facilitates reliable data generation in clinical trials for antiviral therapies, particularly those targeting cytomegalovirus (CMV) and other herpesviruses.
• Forensic and Anti-Doping Analysis: Employed in confirmatory testing protocols where high specificity and accuracy are mandated.

Basic Information

Product Name	Ganciclovir-D5
CAS No.	1189966-73-1
Molecular Formula	C9H8D5N5O4
Molecular Weight	258.27 g/mol
Synonyms	9-[(1,3-Dihydroxy-2-propoxy)methyl]guanine-d5; 2'-Nor-2'-deoxyguanosine-d5; DHPG-d5; BW 759U-d5; Cytovene-d5; Cymevene-d5; Ganciclovir (pentadeuterated); Ganciclovir-d5 Internal Standard
EINECS	Contact for details

Quality Control

Our Ganciclovir-D5 is manufactured under strict quality systems to ensure it meets the exacting requirements for use as a certified reference material. Each batch is characterized using advanced spectroscopic and chromatographic techniques, including NMR and High-Resolution Mass Spectrometry (HRMS), to confirm isotopic purity and chemical identity. A comprehensive Certificate of Analysis (COA) is provided, detailing specifications for chemical purity, isotopic enrichment, and chromatographic performance.

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.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (NMR)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Isotopic Purity (LC-MS)	≥ 99.0 atom % D
Chemical Purity (HPLC)	≥ 95.0%
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.