Description

o-Acetyl n-Benzyloxycarbonyl Valganciclovir-D5 is a deuterated derivative of a key valganciclovir intermediate, specifically designed for use as an internal standard in analytical chemistry. This compound matters because it provides the isotopic purity and structural fidelity required for precise and reliable quantification in complex matrices, ensuring data integrity in critical research and development. It is primarily needed by pharmaceutical R&D laboratories, analytical service providers, and manufacturers engaged in the development, quality control, and bioanalytical studies of antiviral drugs.

Application

• Internal Standard for LC-MS/MS: Essential for the accurate quantification of valganciclovir and its metabolites in pharmacokinetic, bioequivalence, and clinical studies.
• Pharmaceutical Reference Standard: Used in method development, validation, and routine quality control testing of active pharmaceutical ingredients (APIs) and finished drug products.
• Metabolite Research: Aids in the identification and study of drug metabolites in biological samples during preclinical and clinical development phases.
• Stability-Indicating Methods: Employed in forced degradation studies and stability testing to monitor the purity and potency of antiviral formulations.
• Regulatory Submissions: Supports analytical data packages submitted to regulatory bodies like the FDA and EMA for drug approval.
• Isotope Dilution Mass Spectrometry (IDMS): Provides high-accuracy results for trace-level analysis, crucial for impurity profiling and toxicological assessments.

Basic Information

Product Name	o-Acetyl n-Benzyloxycarbonyl Valganciclovir-D5
CAS No.	1356354-05-6
Molecular Formula	C23H25D5N6O7
Molecular Weight	Contact for details
Synonyms	Valganciclovir-D5 Impurity; Valganciclovir Deuterated Intermediate; (2-((2-Amino-1,6-dihydro-6-oxo-9H-purin-9-yl)methoxy)-3-hydroxypropyl)-D5-valine, N-[(Benzyloxy)carbonyl]-, 1-(Acetyloxy)ethyl Ester; L-Valine, N-[(benzyloxy)carbonyl]-, 1-[[(2-amino-1,6-dihydro-6-oxo-9H-purin-9-yl)methoxy]methyl]-2-(acetyloxy)ethyl ester, pentadeutero-; Benzyl N-[(2S)-1-[[(2S)-1-[[(2-amino-6-oxo-1H-purin-9-yl)methoxy]methyl]-2-(acetyloxy)ethoxy]carbonyl]-3-methylbutyl]carbamate-d5
EINECS	Contact for details

Quality Control

Every batch of o-Acetyl n-Benzyloxycarbonyl Valganciclovir-D5 is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure high isotopic purity and chemical identity. Our quality assurance protocols are designed to meet the stringent requirements of pharmaceutical reference standard applications. Comprehensive Certificates of Analysis (COA) detailing purity, isotopic enrichment, and impurity profiles are provided with each shipment.

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 should be handled in a dry environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 98.0%
Isotopic Purity (D-content)	≥ 98 atom % D
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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