Valganciclovir Hydrochloride is a pharmaceutical-grade antiviral active pharmaceutical ingredient (API) and the hydrochloride salt form of valganciclovir. It is an orally administered prodrug of ganciclovir and is used in pharmaceutical formulations associated with cytomegalovirus (CMV) infection and CMV-related conditions.
Valganciclovir Hydrochloride is identified by CAS No. 175865-59-5, molecular formula C14H22N6O5·HCl, and molecular weight 390.82 g/mol. The USP monograph specifies Valganciclovir Hydrochloride to contain not less than 97.0% and not more than 102.0% of the API, calculated on an anhydrous and solvent-free basis.
Valganciclovir Hydrochloride is the hydrochloride salt of valganciclovir, which is a prodrug of ganciclovir. Following administration, valganciclovir is converted to ganciclovir, an antiviral nucleoside analogue that interferes with viral DNA synthesis.
The API has the following principal characteristics:
PubChem also identifies Valganciclovir Hydrochloride as CAS 175865-59-5 with a molecular weight of 390.82 g/mol and describes it as the hydrochloride salt of valganciclovir.
Valganciclovir Hydrochloride is used in pharmaceutical products for appropriate antiviral applications involving cytomegalovirus (CMV).
Its pharmaceutical applications include:
Valganciclovir Hydrochloride is converted to ganciclovir after administration, providing the pharmacologically active antiviral moiety.
The current USP monograph uses multiple identification approaches. These include infrared spectroscopy, chromatographic retention-time comparison of valganciclovir diastereomeric peaks, and chloride identification.
The USP assay uses liquid chromatography and calculates the content from the combined responses of the two valganciclovir diastereomeric peaks. The acceptance range is 97.0–102.0% on an anhydrous and solvent-free basis.
Valganciclovir Hydrochloride has a detailed USP organic-impurity profile. The current USP 2025 text specifies individual limits for several named impurities and an overall total-impurity limit.
Important controls include:
The USP table also separately controls ganciclovir mono-N-methyl valinate at NMT 0.30%, reported as the sum of its diastereomers.
Valganciclovir Hydrochloride contains stereochemical features that require specific control. The USP monograph therefore includes separate tests for enantiomeric purity and diastereomer ratio.
The current USP acceptance criteria are:
The diastereomer ratio is calculated from the two valganciclovir diastereomeric peaks.
The current USP text specifies:
The water test is performed by Water Determination <921>, Method I.
The USP monograph specifically controls isopropyl alcohol, with an acceptance criterion of NMT 1.0%.
This is an important specification for Valganciclovir Hydrochloride and should be retained separately from the organic-impurity profile.
Valganciclovir Hydrochloride can be encountered in different solid-state forms, including crystalline and amorphous forms described in pharmaceutical development literature.
Therefore, when your SDP product is simply listed as Valganciclovir Hydrochloride, the page should not incorrectly claim a specific polymorph such as Form A, Form X or Form Y unless the supplied API has been specifically characterized and released as that form.
The general product page should use:
Solid-State Form: Product-Specific / Crystalline or Amorphous as Applicable
rather than assigning an unsupported polymorphic form.
Swapnroop Drugs & Pharmaceuticals supports pharmaceutical customers requiring Valganciclovir Hydrochloride API for pharmaceutical development and manufacturing applications.
As a Valganciclovir Hydrochloride API manufacturer and supplier in India, the product can be supplied for pharmaceutical applications requiring controlled chemical identity, assay, organic impurities, stereochemical purity, water content and residual-solvent control.
Typical pharmaceutical documentation may include:
Valganciclovir Hydrochloride should be stored in suitable, tightly closed pharmaceutical packaging under controlled conditions according to the approved product specification and stability data.
The USP additional requirements specify preservation in tight containers and storage at controlled room temperature.
Valganciclovir Hydrochloride is a pharmaceutical antiviral API with CAS 175865-59-5, molecular formula C14H22N6O5·HCl, and molecular weight 390.82 g/mol.
The current USP specification provides an assay range of 97.0–102.0%, water content of NMT 8.0%, residue on ignition of NMT 0.10%, isopropyl alcohol of NMT 1.0%, enantiomeric purity of NLT 97.0%, and a diastereomer ratio of 45:55–55:45.
The organic-impurity section contains individual limits ranging from 0.10% to 1.5%, depending on the named impurity, with total impurities NMT 3.0%.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 97.0% – 102.0% |
| Residue on Ignition | NMT 0.10% |
| Total Impurities | NMT 3.0% |
| Water Content | NMT 8.0% |