Nucleosidi e Nucleotidi

<p>Impurity Valganociclovir EP Impurity J<br>Applications Ganciclovir Mono-O-propionate is a potential prodrug of Ganciclovir (G235000). Ganciclovir Mono-O-propionate was also found to exhibit anti-viral activity through experimental studies.<br>References Dias, C.S., et al.: J. Pharma. Sci., 91, 660 (2002);<br></p>

<p>Applications Des-(3-Oxo-3,4-dihydrogen) 3,6-Difluoro Favipiravir is a building block related to Favipiravir(F103350). Favipiravir is used for the treatment of advanced Ebola virus infection in a small animal model. Favipiravir suppressed the replication of Zaire Ebola virus and prevented a lethal outcome in 100% of the animals. Based on the studies, Favipiravir can be a candidate for the treatment of Ebola hemorrhagic fever.<br>References Oestereich, L., et al.: Antiviral Res., 105, 17 (2014); Baranovich, T., et al.: J. Virol. 87, 3741 (2013); Chem. and Eng. News p.8, Dec. 1 (2014)<br></p>

<p>Impurity Abacavir EP Impurity E<br>Applications (1R,3S)-3-[2-Amino-6-(cyclopropylamino)-9H-purin-9-yl]cyclopentanemethanol (Abacavir EP Impurity E) is an impurity of Abacavir (A104990). Abacavir is a carbocyclic 2'-deoxyguanosine nucleoside reverse transcriptase inhibitor and an anti-HIV drug used to treat HIV infection (1). Intracellular enzymes convert Abacavir to its active form, carbovir-triphosphate (CBV-TP), which then selectively inhibits HIV reverse transcriptase by incorporating into viral DNA (2). Abacavir is metabolized in the liver by uridine diphosphate glucuronyltransferase and alcohol dehydrogenase resulting in inactive glucuronide and carboxylate metabolites, respectively.<br>References (1) Jackson, A., et al.: Antivir Ther. 17, 19 (2012) (2) Yuen, G. J., et al.: Clin Pharmacokinet. 47, 351 (2008)<br></p>

<p>Impurity Capecitabine EP Impurity E<br>Applications 5'-Deoxy-5-fluoro-N-[(3-methylbutoxy)carbonyl]cytidine (Capecitabine EP Impurity E) is a 5'-Desoxycytidine derivative and is used as an antitumor agent.<br></p>

<p>Applications 5’-O-Benzoyl Ribavirin is an impurity of Ribavirin (R414475). Ribavirin impurity E.<br>References Zakharieva., et al.: Bioorganic. Medicinal. Chem., 1994, 4, 2831 (1994), Reichard., et al.: The Lancet, 351, 83 (1998),<br></p>

<p>Applications L-Tetrahydrofolic Acid-d4 (Major) is a folic acid derivative and coenzyme involved in the metabolism of amino and nucleic acids.<br>References Prinz-Langenohl, R., et al.: Brit. J. Pharmacol., 158, 2014 (2009), Martin, H., et al.: Anal. Biochem., 402, 137 (2010), Dasarathy, J., et al.: Am. J. Clin. Nut., 91, 357 (2010), Karas-Kuzelicki, N., et al.: Clin. Biochem., 43, 37 (2010),<br></p>

<p>Applications Dopamine labeled biotin (LB) was used as a bifunctional compound to mediate the oxidation of β-nicotinamide adenine dinucleotide (NADH).<br>References Anderson, L., et al.: Clin. Microbiol., 19, 934 (1984), Bayer, E., et al.: Anal. Biochem., 161, 262 (1987), Harmon, F., et al.: J. Biol. Chem., 255, 9458 (1980),<br></p>

<p>Applications A 2-substituted 2’-Deoxyadenosine (D231620). Used in the synthesis of oligonucleotides.<br>References Ishikawa, F., et al.: J. Mol. Biol., 70, 475 (1972), Hattori, M., et al.: Biochemistry, 13, 2754 (1974), Kazimierczuk, Z., et al.: J. Med. Chem., 33, 1683 (1990),<br></p>

<p>Applications Methyl 4-Chlorobenzoate is a reactant used in the synthesis of ataxia-telangiectasia mutated (ATM) kinase, a target for novel radiosensitizing agents. As well, used as a reactant in the synthesis of aminopyridine functionalized polyacrylonitrile fibers.<br>References Min, J. et al.: J. Med. Chem., 59, 559 (2016);<br></p>

<p>Applications 5-O-Trityl-2,3’-anhydrothymidine (cas# 25442-42-6) is a compound useful in organic synthesis.<br></p>

<p>Impurity Valaciclovir EP Impurity P<br>Stability Light Sensitive, Temperature Sensitive<br>Applications Bis Valacyclovir (~90%) (Valaciclovir EP Impurity P) is an impurity is listed in Ph. Eur. monograph for Valaciclovir HCl as impurity P and Bis-valaciclovir in USP monograph (impurity K).<br></p>

<p>Stability Moisture Sensitive<br>Applications 1,2-bis(Chloromethoxy)ethane is a carcinogenic compound.<br>References Kar, S., Roy, K.: Chemoshpere, 87, 339 (2012)<br></p>

<p>Stability Moisture Sensitive<br>Applications 2,3-Dichloropropionyl Chloride is used as a reagent in the synthesis of 6-chloro-5-cyclohexyl-1-indancarboxylic acid, a potent analgesic, antipyretic, and antiinflammatory agent, and its related compounds.<br> Not a dangerous good if item is equal to or less than 1g/ml and there is less than 100g/ml in the package<br>References Sawa, Y., et al.: Yakugaku Zasshi, 96, 653 (1976)<br></p>

<p>Impurity Emtricitabine Carboxylic Acid Impurity<br>Applications Emtricitabine Carboxylic Acid is an impurity of the antiviral agent Emtricitabine (E525035).<br>References Pendela, M. et al.: Talanta, 82, 125 (2010);<br></p>

<p>Applications A new antiviral agent for influenza treatment; it can be used as neuraminidase inhibitor for treating human and avian influenza.<br>References Whitley, R., et al.: Pediatr. Infect. Dis. J., 20, 127 (2001), Bright, R., et al.: Lancet., 366, 1175 (2005), Deyde, V., et al.: J. Infect. Dis., 196, 249 (2007), Lee, N., et al.: Clin. Infect. Dis., 46, 1323 (2008),<br></p>

<p>Stability Hygroscopic<br>Applications D-Melphalan is an isomer of melphalan (M216900), which is an antineoplastic.<br> Not a dangerous good if item is equal to or less than 1g/ml and there is less than 100g/ml in the package<br>References Ross, W.C.J., et al.: Biochem. Pharmacol., 13, 969 (1964); Donelli, M.G., et al.: J. Pharm. Pharmacol., 18, 760 (1966), Furner, R.L., et al.: Cancer Treat. Rep., 64, 559 (1980),<br></p>

<p>Applications Gemcitabine intermediate.<br>References Balzarini, J., et al.: Biochem. Pharmacol., 1988, 37, 2847 (1988), Hertel, L., et al.: Cancer Res., 50, 4417 (1990), Marquez, V., et al.: J. Med. Chem., 33, 978 (1990),<br></p>

<p>Stability Hygroscopic<br>Applications Acyclovir L-Leucinate is an amino acid ester of the antiherpetic agent, Acyclovir (A192400). It is the Leucine analogue of Valacyclovir (V085000).<br>References Burnette, T. et al.: J. Biol. Chem., 270, 15827 (1995);<br></p>

<p>Impurity Ganciclovir EP Impurity C<br>Applications 2’-Monodehydroxy-2’-chloro Ganciclovir is an Impurity of Ganciclovir (G235000). 2’-Monodehydroxy-2’-chloro Ganciclovir is a sugar modified acyclic analogue of guanosine (G837900). Studies have shown 2’-Monodehydroxy-2’-chloro Ganciclovir has potential to exhibit virucidal activity. Iso mono chloro ganciclovir<br>References Martin, J.C., et al.: J. Med. Chem., 29, 1384 (1986);<br></p>

<p>Applications A vitamin needed to synthesize DNA, conduct DNA repair and methylate DNA, it also acts as a cofactor in biological reactions involving folate.<br>References Xu, L., et al.: Mol. Pharm., 7, 1311 (2010), Everette, J., et al.: J. Agric. Food Chem., 58, 8139 (2010), Alshatwi, A., et al.: Food, Chem., Toxicol., 48, 1881 (2010), McKay, D., et al.: Nut. J., 9 (2010),<br></p>

<p>Stability Moisture Sensitive, Unstable in Solution<br>Applications 2-Deoxy-3,5-di-O-p-toluoyl-α-L-ribofuranosyl Chloride (cas# 141846-57-3) is a compound useful in organic synthesis.<br></p>

<p>Applications 5'-Deoxy-5'-chloroadenosine is an intermediate in the synthesis of 5'-Deoxy-5'-(methylthio)adenosine (D242600), a substrate to study the specificity and kinetics of 5′-methylthioadenosinephosphorylase (MTAP) (EC2.4.2.28), a tumor suppressor gene expressed enzyme that supports the S-adenosylmethionine (AdoMet) and methionine salvage pathways.<br>References Olopade, O., et al.: Cancer Res., 53, 2410 (1993), Hartmann, S., et al.: Clin. Chem., 52, 1127 (2006), Penner, N., et al.: J. Pharm. Biomed. Anal., 52, 534 (2010),<br></p>

<p>Applications Inhibitor of enzyme. It is used for Phosphodiesterase Substrate.<br> Not a dangerous good if item is equal to or less than 1g/ml and there is less than 100g/ml in the package<br>References Preuss, C.V., Biochem. Pharmacol., 51, 1661 (1996),<br></p>

<p>Impurity Lamivudine EP Impurity B<br>Applications 2’-Epi-Lamivudine (Lamivudine EP Impurity B) is an epimer of Lamivudine (L172500); an antiviral that inhibits HIV-reverse transcriptase.<br>References Lin, T. et al.: J. Med. Chem., 39, 1757 (1996); Schinazi, R.F. et al.: Antimicrob. Agents Chemother.,36, 672 (1992);<br></p>

<p>Stability Hygroscopic<br>Applications (2'R)​-2'-​Deoxy-​2'-​fluoro-​2'-​methyl-uridine 5'-​Triphosphate Tetrasodium Salt is an impurity of Sofosbuvir (P839640) which is a prodrug that is metabolized to the active antiviral agent 2'-deoxy-2'-α-fluoro-β-C-methyluridine-5'-monophosphate.<br>References Lam, A.M.,et al.: Antimicrob. Agents. Chemotherapy., 56, 3359 (2012); Lam, A.M., et al.: J. Virol., 85, 12334 (2011); Sofia, M.J., et al.: J. Medn. Chem., 53, 7202 (2010);<br></p>

<p>Impurity Lamivudine EP Impurity J<br>Applications (2R-cis)-1-[2-(Hydroxymethyl)-1,3-oxathiolan-5-yl]-2,4(1H,3H)-pyrimidinedione (Lamivudine EP Impurity J) is an impurity of Lamivudine (L172500). (2R-cis)-1-[2-(Hydroxymethyl)-1,3-oxathiolan-5-yl]-2,4(1H,3H)-pyrimidinedione is also being further studied to determine its potential as an anti-HIV agent.<br>References Jeong, L., et al.: J. Med. Chem., 36, 181 (1993)<br></p>

<p>Applications An intermediate in the preparation of Oxiracetam (O846905).<br>References Kondepudi, D., et al.: Science, 250 975 (1990), Di Silvestro, G., et al.: J. Pharm. Sci., 82, 758 (1993),<br></p>

<p>Impurity Penciclovir Impurity F<br>Applications 6-Chloro Desacetyl Famciclovir is a prodrug of Penciclovir (P221500); an antiviral.<br>References Weinberg, A., et al.: Antimicrob. Ag. Chemother., 36, 2037 (1992); McMeekin, J.R., et al.: Anal. Proc., 29, 178 (1992)<br></p>

<p>Impurity Capecitabine EP Impurity D<br>Applications 5'-Deoxy-5-fluoro-N-[(2-methylbutoxy)carbonyl]cytidine (Capecitabine EP Impurity D) is a Capecitabine analog which shows antitumor activity.<br></p>

<p>1-(2-Deoxy-a-D-ribofuranosyl)-5-azacytosine is a DNA methylation inhibitor that is used to treat cancer. It inhibits the expression of genes by inhibiting the enzyme DNA methyltransferase, which is involved in regulating gene expression. 1-(2-Deoxy-a-D-ribofuranosyl)-5-azacytosine has been shown to be effective against squamous cell carcinoma cells and has significant cytotoxicity against these cancer cells. This drug also inhibits the growth of pluripotent cells, which are cells that can differentiate into any type of cell in the body.</p>

<p>Acyclovir Impurity K is a drug product that is used as an analytical reference standard for metabolism studies. Acyclovir Impurity K is a natural product and an impurity of acyclovir, which has CAS No. 1797131-64-6. The chemical name of this drug is 3-hydroxy-2,5,6,7-tetrahydro-1H-[1]benzopyran-2,4(3H)-dione. It can be synthesized in the laboratory by custom synthesis or it can be obtained from a commercial supplier as an impurity standard. This product is used to help with drug development and research and development in the pharmaceutical industry. It can also be used as a high purity HPLC standard for pharmacopoeia testing purposes.</p>

<p>Remdesivir impurity 8 is a metabolite of remdesivir, a drug product that belongs to the class of synthetic compounds. Remdesivir impurity 8 has been used as a research and development standard for HPLC analysis. It is also used as an impurity standard in pharmacopoeia and drug development. This impurity has shown natural activity in metabolism studies, but it is not known if this activity is due to the compound itself or an artifact from its synthesis.</p>

<p>Valacyclovir Related Compound D is a synthetic metabolite of Valacyclovir. It is the primary metabolite of Valacyclovir, which has been shown to inhibit the activity of bacterial DNA polymerase. Valacyclovir Related Compound D is an impurity standard for valacyclovir and can be synthesized in quantities as per customer requirement.</p>

<p>Lamivudine epimer</p>

<p>2'-Deoxy-5,6-didehydro-2',2'-difluoro-6-hydroxyuridine is an analytical standard that is used in research and development of drugs. This compound has been designated as an impurity in a drug product. It has also been used as a reference standard for HPLC analysis. 2'-Deoxy-5,6-didehydro-2',2'-difluoro-6-hydroxyuridine is a metabolite of the drug product. This compound is not found in nature and has been synthesized artificially.</p>

<p>Acyclovir EP Impurity Q is a drug product that is used as the impurity standard for Acyclovir EP. It is a natural metabolite of acyclovir and may be found in the urine of patients taking this drug. Acyclovir EP Impurity Q has shown to have antiviral activity against herpes simplex virus type 1 and type 2. The structure of this compound has been determined by nuclear magnetic resonance (NMR) spectroscopy and mass spectrometry.</p>

<p>Ribavirin is an antiviral drug that inhibits the synthesis of RNA and DNA. It is used to treat human immunodeficiency virus (HIV) infection, hepatitis B, and influenza A. Ribavirin is a nucleoside analog that acts as an antimetabolite by inhibiting acid synthesis in the host cell and therefore blocking viral replication. Ribavirin has been shown to inhibit dna viruses like herpes simplex virus type 1 and 2, as well as RNA viruses like influenza A and respiratory syncytial virus. Ribavirin also binds to the ribonucleotide reductase enzyme, which is necessary for the production of deoxyribonucleotides from ribonucleotides during DNA synthesis, thereby interfering with DNA replication.</p>

<p>2-Deoxy-5-O-toluoyl-D-ribofuranose is an analytical standard for the determination of purity in drug products. It is also used as a reference compound for HPLC and as a metabolite to study metabolism. This impurity can be synthesized from D-ribose and 2(3,4,5)-O-benzylidenebutyraldehyde.</p>

<p>Empagliflozin tetraacetate is a drug product that has been manufactured by chemical synthesis. It is a white to off-white crystalline powder with a molecular weight of 597.7 and a purity of 98.2%. Empagliflozin tetraacetate has been formulated as the hydrochloride salt, which is soluble in water and alcohols. The USP/BP/EP specifications for this drug are 5% impurity standard, analytical, API impurity, Synthetic, Metabolism studies, niche, High purity&gt;. This drug product can be used in research and development as well as for manufacturing pharmaceutical products. It is not intended for use in humans or animals.</p>

<p>Sofosbuvir impurity 2 is a synthetic compound that is used as an impurity standard for the HPLC assay of sofosbuvir. It is a white to off-white crystalline solid at room temperature.</p>

<p>Remdesivir is an antiviral drug that inhibits the viral enzyme, RNA-dependent RNA polymerase. Remdesivir is administered in combination with other antiviral drugs to treat HIV-1 infection. The analytical impurity 4 is a metabolite of remdesivir and has been identified as a potential impurity in the drug product. CAS No. 2096985-18-9 is the molecular weight of this impurity. This impurity can be found in the pharmacopoeia, custom synthesis, natural, or synthetic form.</p>

<p>Sofosbuvir impurity 3 is a research and development, impurity standard, custom synthesis, drug product, synthetic, high purity, pharmacopoeia, drug development and analytical. Sofosbuvir impurity 3 is a metabolite of sofosbuvir which has been studied in metabolism studies using HPLC. This compound has also been shown to inhibit the growth of some bacteria.</p>