Description

Valganciclovir Hydrochloride is the hydrochloride salt of the L-valyl ester prodrug of ganciclovir, a potent antiviral agent. This compound is critical for its enhanced oral bioavailability compared to ganciclovir, making it a cornerstone in systemic antiviral therapy. It is primarily required by the pharmaceutical industry for the formulation of antiviral medications targeting cytomegalovirus (CMV) infections, especially in immunocompromised patients.

Application

• Pharmaceutical Active Ingredient (API): Primary use as the active pharmaceutical ingredient in antiviral tablet formulations.
• Treatment of CMV Retinitis: Used in medications for the treatment of cytomegalovirus (CMV) retinitis in patients with acquired immunodeficiency syndrome (AIDS).
• Prevention of CMV Disease: Employed in prophylactic regimens to prevent CMV disease in solid organ transplant recipients.
• Research & Development: Serves as a key reference standard and intermediate in antiviral drug discovery and pharmacological studies.
• Generic Drug Manufacturing: Essential for the production of generic antiviral drugs following patent expirations.

Basic Information

Product Name	Valganciclovir Hydrochloride
CAS No.	175865-59-5
Molecular Formula	C14H22N6O5•HCl
Molecular Weight	390.82 g/mol (Free base: 354.36)
Synonyms	Valganciclovir HCl; L-Valine, 2-[(2-amino-1,6-dihydro-6-oxo-9H-purin-9-yl)methoxy]-3-methylbutyl ester, monohydrochloride; (S)-2-Amino-3-methylbutyric acid 2-[(2-amino-1,6-dihydro-6-oxo-9H-purin-9-yl)methoxy]-3-methylbutyl ester hydrochloride; Ganciclovir valine ester hydrochloride; Prodrug of Ganciclovir; Valcyte (Brand Name API); RS-79070-003-00
EINECS	Contact for details

Quality Control

Our Valganciclovir Hydrochloride is manufactured under strict quality systems suitable for pharmaceutical applications. We provide material that can be supplied to meet relevant pharmacopeial standards (e.g., USP, EP) for identity, purity, and strength. Certificates of Analysis (COA) documenting comprehensive testing are available for every batch to ensure compliance with your specific requirements.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material 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 to reference standard
Identification (HPLC)	Retention time corresponds to reference
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
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%
Specific Rotation	Contact for details
Microbial Enumeration	Meets Ph. Eur. / USP criteria

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