Valganciclovir Hydrochloride Crystalline Form A is a defined crystalline solid-state form of Valganciclovir Hydrochloride, a pharmaceutical antiviral active pharmaceutical ingredient used in formulations and pharmaceutical development associated with cytomegalovirus (CMV).
Valganciclovir Hydrochloride is the hydrochloride salt of valganciclovir, an orally administered prodrug of ganciclovir. The API is identified by CAS No. 175865-59-5, molecular formula C14H22N6O5·HCl, and molecular weight 390.82 g/mol according to the USP monograph. USP specifies Valganciclovir Hydrochloride at 97.0% to 102.0%, calculated on an anhydrous and solvent-free basis.
Valganciclovir Hydrochloride has been described in multiple solid-state forms. A published patent specifically identifies crystal Form A and crystal Form B and provides powder X-ray diffraction characteristics for distinguishing the two forms.
For Valganciclovir Hydrochloride Crystalline Form A, the patent identifies characteristic powder X-ray diffraction peaks at approximately:
9.4°, 15.6°, 17.1°, 18.2°, 22.0°, 24.7°, 25.7°, 26.3°, 26.7° and 30.0° 2θ
with the peaks reported within the specified tolerance in the patent claims.
Therefore, the term Crystalline Form A should not be used merely to describe any crystalline Valganciclovir Hydrochloride. It should be supported by appropriate solid-state characterization, particularly PXRD.
Valganciclovir Hydrochloride is chemically described as the monohydrochloride salt of valganciclovir. USP identifies the material as:
The USP monograph confirms the chemical identity and assay definition of Valganciclovir Hydrochloride.
Valganciclovir Hydrochloride is associated with antiviral pharmaceutical applications involving cytomegalovirus (CMV). It is converted to ganciclovir following administration and is used in pharmaceutical products for appropriate CMV-related indications.
For API manufacturers and pharmaceutical developers, control of the solid-state form can be important because polymorphism can influence physical properties, processing characteristics and formulation behavior.
The crystalline form of an API represents its molecular arrangement in the solid state. Consequently, Form A should be distinguished from:
The published Form A patent uses powder X-ray diffraction (PXRD/XRD) as the principal solid-state identification method. Differential scanning calorimetry (DSC) is also reported as part of the characterization of Forms A and B.
Valganciclovir Hydrochloride is described as a white to off-white crystalline powder. Published pharmaceutical information reports that the API is hydrophilic and has pH-dependent aqueous solubility. Reported solubility is approximately 70 mg/mL in water at 25°C and pH 7.0, while solubility can exceed 200 mg/mL under acidic conditions in the pH 4–6 range. The reported pKa is approximately 7.6.
The crystalline material can also be affected by environmental moisture. Published information describes Valganciclovir Hydrochloride as moderately hygroscopic.
USP specifies Valganciclovir Hydrochloride with an assay requirement of 97.0–102.0% on an anhydrous and solvent-free basis. The USP monograph also establishes identity and impurity-related controls for the drug substance.
For a product specifically designated Crystalline Form A, chemical quality testing should be accompanied by an appropriate solid-state identification procedure to demonstrate that the supplied material corresponds to Form A.
The chemical assay and impurity requirements should not be confused with the polymorph identity test. A material can meet the chemical assay requirement while still requiring separate characterization to establish its crystalline form.
Swapnroop Drugs & Pharmaceuticals offers pharmaceutical API sourcing and supply support for Valganciclovir Hydrochloride Crystalline Form A, subject to applicable product specifications and solid-state characterization.
As a Valganciclovir Hydrochloride Crystalline Form A API manufacturer and supplier in India, the product can be positioned for pharmaceutical companies and formulation developers requiring a defined crystalline form of this antiviral API.
Typical documentation may include:
Valganciclovir Hydrochloride Crystalline Form A should be stored in suitable pharmaceutical packaging under controlled environmental conditions according to the approved product specification and stability data.
Moisture exposure should be appropriately controlled because published information identifies Valganciclovir Hydrochloride as moderately hygroscopic.
Valganciclovir Hydrochloride Crystalline Form A is a defined solid-state form of Valganciclovir Hydrochloride with CAS 175865-59-5, molecular formula C14H22N6O5·HCl, and molecular weight 390.82 g/mol.
The underlying USP API specification requires 97.0–102.0% assay on an anhydrous and solvent-free basis.
The Form A designation is supported by published PXRD data, including characteristic reflections at approximately 9.4°, 15.6°, 17.1°, 18.2°, 22.0°, 24.7°, 25.7°, 26.3°, 26.7° and 30.0° 2θ.
For a commercial product specifically identified as Form A, the solid-state identity should be confirmed by the applicable validated PXRD method rather than relying solely on the generic description "crystalline."
| 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 |