Description

n-T-Boc-Valacyclovir-D4 is a deuterium-labeled, N-tert-butoxycarbonyl-protected derivative of valacyclovir—specifically deuterated at the valine methyl group—widely employed as a stable isotopic internal standard in quantitative bioanalysis. It delivers exceptional analytical precision and accuracy for LC-MS/MS determination of valacyclovir and its metabolites in biological matrices, enabling reliable pharmacokinetic and bioequivalence studies. This compound is essential for pharmaceutical R&D laboratories, contract research organizations (CROs), and regulatory bioanalytical units requiring trace-level quantification with high reproducibility.

Application

• Internal standard for LC-MS/MS quantification of valacyclovir in human plasma, serum, and urine
• Reference material for method validation (accuracy, precision, matrix effect assessment) per FDA/EMA bioanalytical guidelines
• Calibration standard spiking in high-sensitivity ADME (absorption, distribution, metabolism, excretion) studies
• Quality control reference in GCP-compliant clinical trial bioanalysis laboratories
• Stable isotope dilution assay (SIDA) development for antiviral drug monitoring
• Supporting regulatory submissions (IND, NDA, MAA) requiring rigorous bioanalytical data integrity
• Training and proficiency testing in accredited bioanalytical labs

Basic Information

Product Name	n-T-Boc-Valacyclovir-D4
CAS No.	1346617-11-5
Molecular Formula	C19H32D4N6O6
Molecular Weight	460.52 g/mol
Synonyms	(2S)-2-[[(2R)-2-[[(2-amino-1,1-dimethylethoxy)carbonyl]amino]-3-methylbutanoyl]amino]-3-[2-(6-aminopurin-9-yl)ethoxy]propanoic acid-d4; Nt-Boc-valacyclovir-d4; N-tert-Butoxycarbonyl-valacyclovir-d4; Boc-Val-AcV-d4; Valacyclovir-d4 (N-Boc protected); (2S)-2-(((2R)-2-(((2-amino-1,1-dimethylethoxy)carbonyl)amino)-3-methylbutanoyl)amino)-3-(2-(6-aminopurin-9-yl)ethoxy)propanoic acid-d4; n-Boc-Valacyclovir-d4; 1346617-11-5 (CAS)
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 (≥98% D-incorporation at designated positions), chemical purity (≥98.5% by HPLC), identity (IR, 1H-NMR, MS), and absence of residual solvents and heavy metals. Testing adheres to ICH Q2(R2) and USP General Chapter <1225> for validation of analytical procedures.

Storage

Preserve in a tightly closed container, protected from light. Store at 2–8°C under inert atmosphere (argon or nitrogen) to prevent degradation. Due to its hygroscopic nature, maintain in a low-humidity environment (<30% RH) and minimize exposure to ambient air during handling.

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)	≥98.5%
Isotopic Purity (MS)	≥98% D-incorporation at valine methyl positions
Related Substances (HPLC)	Individual impurity ≤0.3%; Total impurities ≤1.5%
Residual Solvents (GC)	Meets ICH Q3C limits
Water (Karl Fischer)	≤0.5%
Heavy Metals	≤10 ppm

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