Fosamprenavir Calcium API | Pharmaceutical API Manufacturer in India

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Fosamprenavir Calcium is a phosphate prodrug of amprenavir and an antiretroviral pharmaceutical active ingredient used in the treatment of HIV-1 infection. After administration, fosamprenavir is rapidly converted to the active protease inhibitor amprenavir. It belongs to the HIV protease inhibitor class and inhibits HIV-1 protease, an enzyme required for the maturation of infectious viral particles.

Fosamprenavir Calcium is the calcium salt of fosamprenavir and is used in pharmaceutical formulations as the active ingredient. The compound was developed to improve the aqueous solubility and pharmaceutical properties of amprenavir.

Fosamprenavir Calcium API Manufacturer in India

Fosamprenavir Calcium API is a specialized antiretroviral pharmaceutical ingredient used in HIV treatment formulations. It is chemically identified by CAS Number 226700-81-8 and has a molecular formula of C25H35CaN6O9PS with a molecular weight of approximately 674.72 g/mol.

Chemical Information

Fosamprenavir Calcium is a phosphate-containing prodrug of amprenavir. Following administration, intestinal and plasma phosphatases convert fosamprenavir into amprenavir, which provides the principal antiviral pharmacological activity.

CAS Number: 226700-81-8
Molecular Formula: C25H35CaN6O9PS
Molecular Weight: 674.72 g/mol
Development Code: GW433908
Active Metabolite: Amprenavir
Drug Class: HIV Protease Inhibitor
Therapeutic Class: Antiretroviral

Mechanism of Action

Fosamprenavir is converted to amprenavir after administration. Amprenavir selectively inhibits HIV-1 protease, preventing cleavage of viral polyprotein precursors that are necessary for the production of mature infectious HIV particles. This results in the formation of immature, noninfectious viral particles and suppresses viral replication.

Pharmaceutical Applications

Fosamprenavir Calcium is used as an antiretroviral active pharmaceutical ingredient in combination antiretroviral therapy for HIV-1 infection. It has been formulated for oral administration and has been used in combination with other antiretroviral agents.

Physical and Chemical Properties

Fosamprenavir Calcium is a solid pharmaceutical compound. It is a calcium salt of a phosphate-containing prodrug and has relatively high molecular weight due to its salt and hydrate composition. Its physicochemical characteristics support its use in pharmaceutical formulation development.

Quality and Analytical Testing

Fosamprenavir Calcium can be evaluated using pharmaceutical analytical techniques including HPLC assay, chromatographic purity testing, infrared identification, mass spectrometry, water determination, residual solvent testing, elemental impurity testing and other applicable quality-control procedures.

Storage

Fosamprenavir Calcium should be stored in a tightly closed container under controlled conditions and protected from excessive heat, moisture and direct light. Specific storage requirements should follow the applicable validated stability data and product specification.

Pharmaceutical Development

Fosamprenavir Calcium is an important antiretroviral pharmaceutical ingredient because it provides a prodrug approach to the delivery of amprenavir. Its development illustrates the use of phosphate prodrug chemistry to improve the pharmaceutical properties of an established antiviral compound.

Fosamprenavir Calcium API Summary

Fosamprenavir Calcium is a phosphate prodrug of amprenavir and an HIV protease inhibitor used in antiretroviral therapy. It is identified by CAS Number 226700-81-8, molecular formula C25H35CaN6O9PS, and molecular weight approximately 674.72 g/mol. It is primarily used in pharmaceutical formulations for HIV-1 treatment.

Detailed Specifications

Parameter Specification
Appearance White to off-white crystalline powder
Identification IR & HPLC compliant
Assay (HPLC) NLT 98.0% by HPLC
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 2.0%
Water Content NMT 1.0%
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