Ganciclovir

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Ganciclovir dimer

  • CAT Number DCTI-C-1104
  • CAS Number Na
  • Molecular Formula C19H26N10O8
  • Molecular Weight 522.48

Ganciclovir Divalinate

  • CAT Number DCTI-C-1086
  • CAS Number NA
  • Molecular Formula C21H32F3N7O8 (TFA Salt) C19H31N7O6 (Freebase)
  • Molecular Weight 567.52 (TFA Salt) 453.50 (Freebase)

Ganciclovir Mono N-Methyl Valinate (Mixture of Diastereomers)

  • CAT Number DCTI-C-1087
  • CAS Number NA
  • Molecular Formula C17H25F3N6O7 (TFA Salt) C15H24N6O5 (Freebase)
  • Molecular Weight 482.42 (TFA Salt) 368.39 (Freebase)

Ganciclovir related compound A

  • CAT Number DCTI-C-1291
  • CAS Number 86357-09-7 (free base)
  • Molecular Formula C9H14ClN5O4 (HCl Salt) C9H13N5O4 (Free Amine)
  • Molecular Weight 291.69 (HCl Salt) 255.23 (Free Amine)

General Information

Ganciclovir Impurities and Ganciclovir 

Daicel Pharma synthesizes high-quality Ganciclovir impurities like Ganciclovir dimer, Ganciclovir Divalinate, Ganciclovir Mono N-Methyl Valinate (Mixture of Diastereomers), and Ganciclovir related compound A, which are crucial in the analysis of the quality, stability, and biological safety of the active pharmaceutical ingredient Ganciclovir. Moreover, Daicel Pharma offers custom synthesis of Ganciclovir impurities and delivers them globally.

Ganciclovir [CAS: 82410-32-0] is a synthetic guanine derivative with antiviral properties. It manages cytomegalovirus infections in people with AIDS. This drug functions as both an antiviral agent and an anti-infective medication.

Ganciclovir: Use and Commercial Availability  

Ganciclovir is used to manage cytomegalovirus (CMV) infections, which affect the eyes, colon, and esophagus in patients with AIDS or weakened immune systems. It is to prevent and treat CMV infections in patients who have received transplants. The drug is taken orally or administered intravenously. It is available under various brand names, including Cytovene, Ganzyk-Rtu, Ganciclovir Sodium, Vitrasert, and Zirgan.

Ganciclovir Structure and Mechanism of Action Ganciclovir Structure and Mechanism of Action

The chemical name of Ganciclovir is 2-Amino-1,9-dihydro-9-[[2-hydroxy-1-(hydroxymethyl)ethoxy]methyl]-6H-purin-6-one. Its chemical formula is C9H13N5O4, and its molecular weight is approximately 255.23 g/mol.

Ganciclovir is an antiviral drug and a synthetic analog of 2’-deoxyguanosine. It inhibits the replication of human cytomegalovirus (CMV).

Ganciclovir Impurities and Synthesis

Ganciclovir impurities are unwanted substances that form during manufacturing1,2 or storage of Ganciclovir drug substance or product. These impurities can affect the drug’s quality, safety, and efficacy. Understanding the formation and synthesis of these impurities is essential to identify and controlling them and ensuring that the drug is of high quality and purity.

Daicel offers a Certificate of Analysis (CoA) from a cGMP-compliant analytical facility for Ganciclovir impurity standards, Ganciclovir dimer, Ganciclovir Divalinate, Ganciclovir Mono N-Methyl Valinate (Mixture of Diastereomers), and Ganciclovir related compound A. The CoA includes complete characterization data, such as 1H NMR, 13C NMR, IR, MASS, and HPLC purity3. We also provide 13C-DEPT and CHN if requested. We give a complete characterization report on delivery. Daicel has the technology and expertise to prepare any unknown Ganciclovir impurity or degradation product.

References
FAQ's

Frequently Asked Questions

Impurities in Ganciclovir can originate from starting materials, reagents, or by-products formed during synthesis. They can also occur during the storage or degradation of the drug.

Ganciclovir impurities reduce the drug efficacy by competing with the active ingredient for receptor binding sites or decreasing the bioavailability of the drug.

Methanol or water are the solvents for analyzing most of the Ganciclovir impurities.

Ganciclovir impurities are stored at a controlled room temperature between 2-8 ⁰C or as indicated on the Certificate of Analysis (CoA).

Note: Products protected by valid patents by a manufacturer are not offered for sale in countries having patent protection. The sale of such products constitutes a patent infringement, and its liability is at the buyer's risk.

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