Valganciclovir Hydrochloride Crystalline is a pharmaceutical-grade antiviral active pharmaceutical ingredient used in the development and manufacture of pharmaceutical formulations for cytomegalovirus (CMV) applications. Valganciclovir Hydrochloride is the hydrochloride salt of valganciclovir, an orally administered prodrug that is converted to ganciclovir after administration.
Valganciclovir Hydrochloride is identified by CAS No. 175865-59-5, molecular formula C14H22N6O5·HCl, and molecular weight approximately 390.82 g/mol. The current USP monograph defines Valganciclovir Hydrochloride as containing 97.0% to 102.0% of the drug substance, calculated on an anhydrous and solvent-free basis.
Valganciclovir Hydrochloride belongs to the nucleoside analogue antiviral class. It is structurally related to ganciclovir and functions as a prodrug that is converted to ganciclovir in the body.
The hydrochloride API is described as a white to off-white crystalline powder. The crystalline material is chemically the same Valganciclovir Hydrochloride API but differs from amorphous material in its solid-state molecular arrangement.
Valganciclovir Hydrochloride has been reported to exist in two crystalline polymorphic forms, Form X and Form Y, in addition to an amorphous form. Patent literature describing pharmaceutical development reports that the commercial manufacturing process produced crystalline Form Y and that Form Y was used in formulation development, clinical, stability and registration batches.
For an API marketed simply as Valganciclovir Hydrochloride Crystalline, the solid-state description should identify the material as crystalline. Where the supplier's validated characterization confirms a particular polymorph, the specification should additionally identify the polymorphic form, such as Form Y.
Valganciclovir Hydrochloride is a polar and hydrophilic compound. Published pharmaceutical development information reports water solubility of approximately 70 mg/mL at 25°C and pH 7.0. Its solubility is strongly pH dependent, with substantially higher solubility under acidic conditions; reported maximum solubility is greater than 200 mg/mL at pH 4–6. The reported pKa is approximately 7.6.
Valganciclovir Hydrochloride is also described as moderately hygroscopic. Published information reports moisture uptake under elevated relative humidity and indicates that the material can reversibly absorb or release moisture depending on its initial water content and environmental humidity.
Valganciclovir Hydrochloride is associated with pharmaceutical applications involving:
The active ingredient is converted to ganciclovir following administration, making Valganciclovir Hydrochloride an important prodrug-based antiviral API.
The crystalline form can be relevant to pharmaceutical development because the solid-state arrangement of an API may affect properties such as physical stability, moisture behavior, powder handling and formulation processing.
For a crystalline API, appropriate solid-state characterization may be used to confirm the intended crystalline state and, where required, distinguish the specified polymorphic form. XRPD is commonly appropriate for confirming crystalline solid-state identity, while DSC and related analytical techniques may provide additional characterization.
The crystalline form should therefore be described accurately in the product specification rather than treating crystalline and amorphous Valganciclovir Hydrochloride as interchangeable solid-state materials.
The USP monograph specifies Valganciclovir Hydrochloride at 97.0–102.0%, calculated on an anhydrous and solvent-free basis. USP identification includes infrared absorption, ultraviolet absorption and chloride identification. The monograph also controls water and residue on ignition and includes impurity-related requirements.
For commercial pharmaceutical API supply, the final release specification should be based on the applicable pharmacopoeial monograph and the manufacturer's approved product specification.
Swapnroop Drugs & Pharmaceuticals supports pharmaceutical customers requiring Valganciclovir Hydrochloride Crystalline API for pharmaceutical development and manufacturing applications.
As a Valganciclovir Hydrochloride Crystalline API manufacturer and supplier in India, the product can be positioned for customers requiring a crystalline antiviral API with appropriate chemical, impurity, moisture and solid-state controls.
Typical documentation associated with pharmaceutical API supply may include:
Valganciclovir Hydrochloride should be stored in appropriate pharmaceutical packaging and under controlled environmental conditions according to the approved product specification and stability data.
Because the API is moderately hygroscopic, moisture exposure should be controlled during storage and handling. Published information indicates that Valganciclovir Hydrochloride can reversibly absorb and release moisture depending on environmental humidity.
Valganciclovir Hydrochloride Crystalline is a hydrochloride salt of the antiviral prodrug valganciclovir and is identified by CAS 175865-59-5. It has a molecular formula of C14H22N6O5·HCl and molecular weight of approximately 390.82 g/mol. USP specifies an assay range of 97.0–102.0% on anhydrous and solvent-free basis.
The API has documented crystalline Forms X and Y, with Form Y reported in patent literature as the form produced by the commercial manufacturing process described therein. Therefore, when a specific polymorphic form is supplied, the product specification should identify that form separately from the general chemical identity of Valganciclovir Hydrochloride.
| 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% |
| Individual Impurity | NMT 0.20% |
| Total Impurities | NMT 3.5% |
| Water Content | NMT 8.0% |
| Solubility | Approximately 70 mg/mL in water at 25°C, pH 7; >200 mg/mL reported at pH 4–6 |