Description

Valganciclovir is the L-valyl ester prodrug of the antiviral agent ganciclovir, designed to significantly enhance oral bioavailability. This compound is a critical active pharmaceutical ingredient (API) primarily used in the formulation of antiviral medications. It is essential for pharmaceutical manufacturers and research institutions developing treatments for cytomegalovirus (CMV) infections, particularly in immunocompromised patients. The product is supplied as a high-purity material suitable for GMP manufacturing processes.

Application

• Pharmaceutical API: Primary use as the active ingredient in antiviral tablet formulations.
• CMV Prophylaxis and Treatment: For the prevention and treatment of cytomegalovirus disease in transplant recipients (e.g., kidney, heart, pancreas).
• Treatment of CMV Retinitis: Used in the management of sight-threatening CMV retinitis in patients with AIDS.
• Pediatric Formulations: Development of oral solutions or powder formulations for pediatric patients.
• Generic Drug Manufacturing: Sourcing of the API for the production of generic antiviral medications.
• Research and Development: Used in preclinical and clinical studies for new antiviral therapies and drug delivery systems.

Basic Information

Product Name	Valganciclovir
CAS No.	175865-60-8
Molecular Formula	C14H22N6O5
Molecular Weight	354.36 g/mol
Synonyms	Valganciclovir Hydrochloride; L-Valine, 2-[(2-amino-1,6-dihydro-6-oxo-9H-purin-9-yl)methoxy]-3-methylbutyl ester; Valcyte (Brand Name); (S)-2-Amino-3-methylbutyric Acid 2-[(2-Amino-1,6-dihydro-6-oxo-9H-purin-9-yl)methoxy]-3-hydroxypropyl Ester; Ganciclovir L-Valyl Ester; RS-79070; Ro 107-9070/000; 9-[[2-Hydroxy-1-(hydroxymethyl)ethoxy]methyl]guanine Valyl Ester
EINECS	Contact for details

Quality Control

Our Valganciclovir is manufactured under strict quality systems to ensure it meets the stringent requirements for pharmaceutical use. Quality is verified through comprehensive analytical testing, including HPLC for assay and impurity profiling, chiral purity determination, and residual solvent analysis. We provide full traceability and support regulatory filings with detailed documentation. A Certificate of Analysis (COA) confirming compliance with in-house specifications is supplied with each batch.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). The product is hygroscopic (moisture-sensitive) and must be kept in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms
Identification (HPLC)	Conforms to reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Chiral Purity (HPLC)	≥ 99.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Individual impurity ≤ 0.5%; Total impurities ≤ 1.5%
Microbial Limits	Conforms to EP/USP criteria

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