Ganciclovir Sodium API | Pharmaceutical API Manufacturer in India

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Ganciclovir Sodium API

Ganciclovir Sodium is the sodium salt of ganciclovir, an acyclic guanine nucleoside analogue with antiviral activity against cytomegalovirus (CMV). It is used as a pharmaceutical active ingredient for the development of antiviral formulations, particularly parenteral preparations.

Ganciclovir Sodium acts after intracellular phosphorylation to the active triphosphate metabolite, which inhibits viral DNA polymerase and suppresses viral DNA replication.

Ganciclovir Sodium API Manufacturer in India

Ganciclovir Sodium is a specialized antiviral API used in pharmaceutical formulations for the management of serious CMV infections, particularly in immunocompromised patients. Its sodium salt form provides the appropriate physicochemical characteristics for pharmaceutical formulation.

Chemical Information

CAS Number: 107910-73-6
Molecular Formula: C9H12N5NaO4
Molecular Weight: 277.22 g/mol
Parent Compound: Ganciclovir
Salt Form: Sodium Salt
Drug Class: Acyclic Nucleoside Analogue Antiviral
Therapeutic Class: Antiviral
Therapeutic Area: Infectious Diseases / Virology

Mechanism of Action

Ganciclovir Sodium is converted to ganciclovir and subsequently phosphorylated inside infected cells. The active ganciclovir triphosphate competitively inhibits viral DNA polymerase and can be incorporated into viral DNA, resulting in inhibition of viral DNA synthesis and replication.

Pharmaceutical Applications

Ganciclovir Sodium is primarily associated with pharmaceutical preparations intended for treatment of serious cytomegalovirus (CMV) infections. It is particularly relevant to antiviral therapy in immunocompromised patients.

Ganciclovir Sodium and CMV

CMV is a member of the herpesvirus family and can cause significant disease in patients with weakened immune systems. Ganciclovir Sodium provides the active ganciclovir moiety that interferes with viral DNA replication.

Physical and Chemical Properties

Ganciclovir Sodium is an ionic sodium salt of ganciclovir. It has the molecular formula C9H12N5NaO4 and molecular weight 277.22 g/mol. The sodium salt is highly polar and is suitable for pharmaceutical formulations where aqueous solubility is required.

Quality and Analytical Testing

Ganciclovir Sodium API quality evaluation may include identification by IR and HPLC, assay by HPLC, related substances, water content, residual solvents, sodium content, elemental impurities and other applicable pharmaceutical quality-control tests.

Storage

Ganciclovir Sodium should be stored in a tightly closed container under controlled pharmaceutical conditions and protected from excessive heat, moisture and direct light. Exact storage conditions should follow validated stability data and the applicable material specification.

Pharmaceutical Research and Development

Ganciclovir Sodium is an important antiviral pharmaceutical ingredient in CMV research and drug development. Its conversion to active ganciclovir and subsequent inhibition of viral DNA polymerase provide the pharmacological basis for its antiviral activity.

Ganciclovir Sodium API Summary

Ganciclovir Sodium is the sodium salt form of ganciclovir, an acyclic guanine nucleoside analogue antiviral. It is identified by CAS Number 107910-73-6, molecular formula C9H12N5NaO4, and molecular weight 277.22 g/mol. It is primarily associated with pharmaceutical formulations for serious CMV infections.

Detailed Specifications

Parameter Specification
Appearance White to off-white crystalline powder
Identification IR & HPLC compliant
Assay (HPLC) 98.0% – 102.0%
Loss on Drying NMT 2.0%
Residue on Ignition NMT 1.0%
Heavy Metals NMT 20 ppm
pH (1% Solution) 9.0 – 11.0
Individual Impurity NMT 0.5%
Total Impurities NMT 2.0%
Water Content NMT 2.0%
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