Description

Desdiacetyl-8-Oxo Famciclovir-D4 is a deuterium-labeled analytical reference standard and pharmaceutical intermediate derived from the antiviral prodrug famciclovir. It serves as a critical tool for quantitative bioanalysis, metabolic stability studies, and pharmacokinetic (PK) assay development in drug discovery and regulatory submission support. This compound is essential for laboratories conducting LC-MS/MS method validation, isotopic dilution assays, and impurity profiling of famciclovir-related compounds. Researchers and contract research organizations (CROs) in global pharmaceutical R&D, clinical trial support, and regulatory compliance testing rely on its high isotopic fidelity and batch-to-batch consistency.

Application

• Internal standard for LC-MS/MS quantification of famciclovir and its metabolites in human plasma, urine, and tissue homogenates
• Reference material for method validation and calibration curve construction per FDA/ICH bioanalytical guidelines
• Metabolic pathway tracing in hepatic microsome and hepatocyte incubation studies
• Stability-indicating assay development for forced degradation studies of famciclovir formulations
• Quality control reference for synthesis of deuterated antiviral analogues
• Supporting regulatory submissions (IND, NDA, MAA) requiring isotopically labeled standards with documented traceability
• Proficiency testing and inter-laboratory comparison programs in accredited bioanalytical labs
• Development of stable-isotope dilution mass spectrometry (SID-MS) workflows for GCP-compliant clinical trials

Basic Information

Product Name	Desdiacetyl-8-Oxo Famciclovir-D4
CAS No.	1346603-55-1
Molecular Formula	C11D4H11N5O4
Molecular Weight	297.28 g/mol
Synonyms	Desdiacetylfamciclovir-D4; 8-Oxo-desdiacetylfamciclovir-d4; 2-Amino-9-[(2R,3R,4S)-3,4-dihydroxy-2-(hydroxymethyl)tetrahydrofuran-2-yl]-6-(deuteromethyl)-1H-purin-6-ium-7-olate-d4; Desdiacetyl-8-oxo-famciclovir-d4; 8-Oxo-desdiacetyl-famciclovir-D4; NSC 751292-D4; 2-Amino-9-[(2R,3R,4S)-3,4-dihydroxy-2-(hydroxymethyl)tetrahydrofuran-2-yl]-6-(methyl-d3)-1H-purin-6-ium-7-olate-d1; Famciclovir metabolite D4 standard
EINECS	Contact for details

Quality Control

Our products undergo rigorous quality testing to ensure compliance with industry standards. Certificates of Analysis (COA) are available upon request. Each batch is verified for isotopic enrichment (≥99% D at designated positions), chemical purity (≥98.5% by HPLC-UV), structural identity (NMR, IR, HRMS), and absence of residual solvents (per ICH Q3C). Testing adheres to ISO/IEC 17025-accredited practices and supports compliance with FDA 21 CFR Part 11, EU GMP Annex 11, and ICH Q5C guidelines for reference standards.

Storage

Preserve in a tightly closed container, protected from light. Store at 2–8 °C under inert atmosphere (argon or nitrogen) to prevent oxidation and moisture uptake. Due to its hygroscopic nature, minimize exposure to ambient humidity during handling. Keep desiccated and avoid repeated freeze-thaw cycles.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC-UV)	≥98.5%
Isotopic Enrichment (HRMS)	≥99% D at C6-methyl and C8 positions
Related Substances (HPLC)	Single impurity ≤0.3%; Total impurities ≤0.5%
Residual Solvents (GC)	Meets ICH Q3C Class 3 limits
Water Content (Karl Fischer)	≤0.5%

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