Swapnroop Drugs & Pharmaceuticals is a pharmaceutical API manufacturer and supplier of Valganciclovir Hydrochloride Amorphous, a pharmaceutical form of valganciclovir hydrochloride used in antiviral pharmaceutical formulations and development.
Valganciclovir Hydrochloride is the hydrochloride salt of valganciclovir, an orally administered prodrug of ganciclovir. It is an antiviral active pharmaceutical ingredient associated primarily with the prevention and treatment of cytomegalovirus (CMV) infection and CMV retinitis in appropriate patient populations.
The API is identified by CAS No. 175865-59-5, molecular formula C14H22N6O5·HCl, and molecular weight approximately 390.83 g/mol. FDA chemistry documentation identifies the hydrochloride as Valganciclovir HCl and distinguishes it from the free base, CAS 175865-60-8.
Valganciclovir is a L-valyl ester prodrug of ganciclovir. Following administration, it is converted to ganciclovir, which is subsequently phosphorylated within infected cells and interferes with viral DNA synthesis.
FDA regulatory documentation identifies Valganciclovir Hydrochloride as a nucleoside analogue antiviral. The original Valcyte chemistry review identifies its pharmaceutical application in the treatment of CMV retinitis.
The amorphous designation refers to the solid-state form of the API. It should therefore be distinguished from crystalline polymorphic forms when describing the product to pharmaceutical customers.
The FDA chemistry review confirms the hydrochloride salt identity, CAS number, molecular formula and molecular weight.
Valganciclovir Hydrochloride API is used in pharmaceutical applications involving:
FDA documentation identifies Valcyte as a valganciclovir hydrochloride product and describes its use for CMV retinitis and prevention of CMV disease in high-risk patients.
The amorphous form is a non-crystalline solid-state form of Valganciclovir Hydrochloride. Solid-state form can influence important pharmaceutical properties such as:
For this reason, the product description should specifically identify the material as Valganciclovir Hydrochloride Amorphous when that is the supplied solid-state form.
Swapnroop Drugs & Pharmaceuticals supports pharmaceutical companies requiring Valganciclovir Hydrochloride Amorphous API for pharmaceutical formulation development and manufacturing applications.
As a Valganciclovir Hydrochloride Amorphous API manufacturer and supplier in India, Swapnroop focuses on appropriate control of:
Valganciclovir Hydrochloride Amorphous should be stored in suitable pharmaceutical packaging under controlled environmental conditions according to the approved product specification and stability data.
Because the amorphous solid form can have different physical behavior from crystalline material, appropriate moisture and environmental controls should be established according to validated stability studies.
Typical pharmaceutical documentation may include:
Swapnroop Drugs & Pharmaceuticals supports pharmaceutical customers seeking Valganciclovir Hydrochloride Amorphous API for antiviral formulation and pharmaceutical development, with emphasis on chemical identity, impurity control, solid-state characterization and appropriate pharmaceutical documentation.
| 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% |