Foscarnet Impurities and Foscarnet
Daicel Pharma specializes in synthesizing impurities for Foscarnet, an active pharmaceutical ingredient. We offer impurities such as Foscarnet Related Compound A, Foscarnet Related compound B, and Foscarnet Related Compound C, which play a vital role in evaluating Foscarnet purity and safety. Daicel Pharma also provides custom synthesis of Foscarnet impurities to meet specific client needs and offer worldwide delivery options.
Foscarnet [CAS: 4428-95-9] is a synthetic organic analog of inorganic pyrophosphate that exhibits antiviral activity against several viruses. It treats cytomegalovirus retinitis, a viral infection that affects the eye retina. In addition to its efficacy against cytomegalovirus, Foscarnet also demonstrates activity against human herpes viruses and HIV, making it a valuable antiviral agent for treating these infections.
Foscarnet: Use and Commercial Availability
Foscarnet, marketed under Foscavir, is a US FDA-approved antiviral medication for treating viral infections. It treats cytomegalovirus (CMV) and CMV-associated ophthalmic retinitis in AIDS patients who cannot tolerate ganciclovir. Foscarnet also treats immunocompromised patients with herpes simplex virus (HSV) who exhibit resistance to acyclovir, the standard therapy for HSV. When ganciclovir alone proves ineffective or causes significant side effects, clinicians may opt for Foscarnet as monotherapy or in combination with other medications.
Foscarnet Structure and Mechanism of Action
The chemical name of Foscarnet is 1,1-dihydroxy-phosphinecarboxylic acid 1-oxide. Its chemical formula is CH3O5P, and its molecular weight is approximately 126.01 g/mol.
Foscarnet prevents the replication of herpes viruses by inhibiting pyrophosphate binding sites on virus-specific DNA polymerases.
Foscarnet Impurities and Synthesis
Impurities in Foscarnet refer to undesired substances in the drug product that are not the intended active pharmaceutical ingredient (API). They can arise during the manufacturing process or storage of Foscarnet. The common impurities in Foscarnet may include related compounds, degradation products, residual solvents, or by-products from synthesis. It is crucial to control and monitor Foscarnet impurities to ensure the medication’s safety, efficacy, and quality.
Daicel Pharma, in adherence to cGMP standards, operates an analytical facility where we prepare Foscarnet impurity standards like Foscarnet Related Compound A, Foscarnet Related Compound B, and Foscarnet Related Compound C. We offer a comprehensive Certificate of Analysis (CoA) for these impurities, providing a detailed characterization report. The CoA includes data obtained through techniques, 1H NMR, 13C NMR, IR, MASS, and HPLC purity analysis1,2. Upon request, we give additional data like 13C-DEPT. We can synthesize unknown Foscarnet impurities or degradation products. Each delivery has a comprehensive characterization report.
- Pettersson, K. J.; Nordgren, T.; Westerlund, D., Determination of phosphonoformate (Foscarnet) in biological fluids by ion-pair reversed-phase liquid chromatography, Journal of Chromatography, Biomedical Applications, Volume: 488, Issue: 2, Pages: 447-55, 1989
- Garcia, Javier; Marquez, Apolonia; Ruiz, Rosa; Lopez, Luis F.; Claro, Carmen; Lucero, Maria Jesus, Determination of foscarnet (trisodium phosphonoformate) in pharmaceutical preparations by high-performance liquid chromatography with ultraviolet detection, Biomedical Chromatography, Volume: 20, Issue: 10, Pages: 1024-1027, 2006
Frequently Asked Questions
Impurities in Foscarnet are identified and characterized using various analytical techniques such as spectroscopy, chromatography, and mass spectrometry. These methods allow for the identification, quantification, and structural elucidation of impurities in the drug substance or product.
Yes, impurities in Foscarnet can potentially affect its stability. Some of them may contribute to degradation reactions, which can compromise the stability and shelf life of the medication. Therefore, it is necessary to control them to ensure the long-term stability of Foscarnet.
Specific tests and methods are employed to assess impurities in Foscarnet during quality control testing. They may include related substances analysis, residual solvent testing, degradation product evaluation, etc. These tests help ensure that impurity levels are within acceptable limits.
Water is the solvent used when analyzing many impurities in Foscarnet.
The recommendation is to store Foscarnet impurities at a controlled room temperature, within 2-8 ⁰C.
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