Ganciclovir API | Pharmaceutical API Manufacturer in India

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Ganciclovir API

Ganciclovir is a synthetic acyclic nucleoside analogue antiviral used primarily against infections caused by cytomegalovirus (CMV). It inhibits viral DNA synthesis after intracellular phosphorylation to its active triphosphate form. Ganciclovir is particularly important in the management of serious CMV infections in immunocompromised patients.

Ganciclovir API Manufacturer in India

Ganciclovir is a specialized antiviral pharmaceutical active ingredient used in the development and manufacture of medicines for CMV infections. It is available in pharmaceutical formulations including intravenous preparations and ophthalmic formulations of its prodrug derivatives.

Chemical Information

CAS Number: 82410-32-0
Molecular Formula: C9H13N5O4
Molecular Weight: 255.23 g/mol
Drug Class: Nucleoside Analogue Antiviral
Therapeutic Class: Antiviral
Therapeutic Area: Infectious Diseases / Virology

Mechanism of Action

Ganciclovir is phosphorylated intracellularly, initially by viral and cellular kinases and subsequently by cellular enzymes, to form ganciclovir triphosphate. The active metabolite inhibits viral DNA polymerase and can become incorporated into viral DNA, thereby suppressing viral DNA synthesis and replication.

Pharmaceutical Applications

Ganciclovir is primarily used for the treatment and prevention of serious cytomegalovirus (CMV) infections, particularly in immunocompromised patients. It has applications in CMV retinitis and other serious CMV disease settings.

Ganciclovir and CMV

Cytomegalovirus is a herpesvirus that can cause severe disease in individuals with compromised immune systems. Ganciclovir targets viral DNA replication and therefore has specific antiviral activity against CMV and other susceptible herpesviruses.

Ganciclovir Chemical Properties

Ganciclovir is an acyclic guanine nucleoside analogue. It contains a purine ring and multiple hydroxyl groups that contribute to its polar character. The compound has a molecular formula of C9H13N5O4 and molecular weight of 255.23 g/mol.

Quality and Analytical Testing

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

Storage

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

Pharmaceutical Research and Development

Ganciclovir is an important antiviral compound in CMV research and pharmaceutical development. Its selective activation within infected cells and inhibition of viral DNA polymerase form the basis of its antiviral activity.

Ganciclovir API Summary

Ganciclovir is an acyclic nucleoside analogue antiviral identified by CAS Number 82410-32-0, with molecular formula C9H13N5O4 and molecular weight 255.23 g/mol. It is primarily used against serious CMV infections and acts by inhibiting viral DNA synthesis.

Detailed Specifications

Parameter Specification
Appearance White to off-white crystalline powder
Identification Conforms by IR and HPLC
Assay (HPLC) 98.0% – 102.0%
Loss on Drying NMT 1.0%
Residue on Ignition NMT 0.5%
Heavy Metals NMT 10 ppm
pH (1% Solution) 5.0 – 7.0
Individual Impurity NMT 0.5%
Total Impurities NMT 1.0%
Water Content NMT 1.0%
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