Estándares farmacéuticos

Applications Impurity of Bivalirudin, a direct thrombin inhibitor acting as an anticoagulant through inhibition of the enzyme thrombin.
References Bertrand, O. et al.: Am. J. Cardio., 110, 599 (2012); Patti, G. et al.: Am. J. Cardio., 110, 478 (2012);

Applications Roquefortine C is a potent neurotoxin produced most notably by Penicillium species.
Not a dangerous good if item is equal to or less than 1g/ml and there is less than 100g/ml in the package

Applications 2-Chloronaphthalene-d7 (CAS# 93951-84-9) is a useful isotopically labeled research compound.

Applications Ferulic Acid-d3 4-O-Sulfate Disodium Salt, is a labeled analogue of Ferulic Acid 4-O-Sulfate Disodium Salt (F308920), a metabolite of Ferulic Acid. Ferulic Acid 4-O-Sulfate is one of the circulating metabolites in human plasma after consumption polyphenol-rich juice drink.
References Fumeaux, R., et al.: Org. Biomol. Chem., 8, 5199 (2010); Mullen, W., et al.: J. Agric. Food Chem., 58, 2586 (2010);

Applications N-Acetylthiourea is a derivative of Thiourea (T375450); a compound used in biochemistry to increase the solubility (and resolution) of membrane proteins in two-dimensional electrophoresis. N-Acetylthiourea can be used as a reducing agent in a two-part self curing endodontic sealing system.
Not a dangerous good if item is equal to or less than 1g/ml and there is less than 100g/ml in the package
References Jabbour, S.: Am. J. Clin. Dermatol., 4, 315 (2003); Himsworth, H.: Lancet, 242, 465 (1943); Rabilloud, T., et al.: Electrophoresis, 19, 758 (1998); Jin, S. et al. Self-curing system for endodontic sealant applications. PCT Int. Appl. WO 2009018464 A2 20090205. Feb 5, 2009

Applications 3-(4-(2,3-Epoxypropoxy)phenyl)propionic Acid Methyl Ester is an intermediate in the synthesis of N-Ethyl Esmolol (E918045), which is an impurity of esmolol (E668000), which is a cardioselective β-adrenergic blocker. Antiarrhythmic.
References Gorczynski, R.J., et al.: J. Cardiovasc. Pharmacol., 5, 668 (1983), Yacobi, A., et al.: J. Pharm. Sci., 72, 711 (1983), Benfield, P., et al.: Drugs, 33, 392 (1987)

Applications 5α-Pregnane-3β,20(S)-diol, is a metabolite of Progesterone (P755900).
References Beall, et al.: Biochem. J., 31, 35 (1937), Okuda, A., et al.: J. Biol. Chem., 259, 7519 (1984), Russell, D., et al.: Biochemistry, 31, 4737 (1992), Kondo, K., et al.: Eur. J. Biochem., 219, 357 (1994), Westerbacka, J., et al.: J. Clin. Endocrinol. Metab., 88, 4924 (2003),

Stability Hygroscopic
Applications A labelled bisphenol derivative having antihemolytic activity.
References Morgan, B., et al.: Eur. J. Clin. Invest., 24, 219 (1994), Liszewski, M., et al.: Adv. Immunol., 61, 201 (1996), Assefa, H., et al.: Bioorg. Med. Chem. Lett., 9, 1889 (1999), Burdelev, O., et al.: Bioorg. Khim., 29, 159 (2003),

Applications [Leu5]-Enkephalin is a neurotransmitter used in molecular dynamics studies for the insertion of neurotransmitters into lipid bilayer membranes and their implication on membrane stability.
References Shen, C., et al.: ChemPhysChem, pages ahead of print (2017)

Stability Hygroscopic
Applications Rosuvastatin tert-Butyl Ester, is a metabolite of Rosuvastatin (R700500) a selective, competitive HMG-CoA reductase inhibitor.
References Watanabe, M., et al.: Bioorg. Med. Chem., 5, 437 (1997), Lee, E., et al.: Clin. Pharmacol. Ther., 78, 330 (2005), Ferdinand, K.C., et al.: Am. J. Cardiol., 97, 229 (2006),

Applications A labelled inactive metabolite of Prasugrel (P701150).
References Sugidachi, A., et al.: Br. J. Pharmacol., 129, 1439 (2000); Takahashi, S., et al.: J. Pharm. Sci., 97, 5434 (2008); Williams, E., et al.: Drug Metab. Dispos., 36, 1227 (2008); Hagihara, K., et al.: Xenobiotica, 39, 218 (2009);

Impurity Atorvastatin EP Impurity G
Applications Atorvastatin derivative.

Applications Carbon 13 Labelled analogue of Adenosine (A280400), a purine nucleoside that plays an important role in various biochemical processes.
References Long, X., et al.: J. Pharmacol. Exper. Ther., 335, 781 (2010); Ham, M., et al.: J. Pharmacol. Exper. Ther., 335, 607 (2010)

Applications 2,6-Di-tert-butyl-p-cresol (cas# 128-37-0) is a compound useful in organic synthesis.
Not a dangerous good if item is equal to or less than 1g/ml and there is less than 100g/ml in the package

Applications: An impurity contained in samples of all trans-retinoic acid.
References Newton, D., et al.: Cancer Res., 40, 3413 (1980), Curley, R., et al.: Bioorg. Med. Chem. Lett., 2, 1133 (1992), Tanaka, H., et al.: Chem. Pharm. Bull., 43, 356 (1995), Patel, J., et al.: J. Med. Chem., 47, 6716 (2004),

Applications Labelled Cyclamic acid. A non-nutritive sweetener.
References Taylor, et al.: Food Cosmet. Toxicol., 6, 313 (1968), Brantom, et al.: Food Cosmet. Toxicol., 11, 735 (1973),

Applications 2,2'-Thiodiacetic Acid is a highly flexible ligand used in the synthesis of a series of metal complexes.
Not a dangerous good if item is equal to or less than 1g/ml and there is less than 100g/ml in the package
References Hou, X., et al.: Chin. J. Struct. Chem., 32, 1339 (2013); Wu, X.X., et al.: Synth. React. Inorg. Me., 44, 486 (2014); Ma, C., et al.: J. Inorg. Organomet. P., 22, 1206 (2012)

Impurity Beclomethasone Dipropionate EP Impurity B
Applications Beclomethasone 21-Acetate 17-Propionate (Beclomethasone Dipropionate EP Impurity B) is an impurity of Beclomethasone Dipropionate (B131030).

Applications Clocortolone Acetate is an intermediate in the synthesis of Clocortolone (C583800), an corticosteroid used in the treatment of skin inflammmation and other skin conditions arising for dermatoses.
References Rehm, K. et al.: Pharmaz. Zeit., 127, 888 (1982);

Applications Diltiazem (D460620) intermediate (impurity B).
References Chaffman, M., et al.: Drugs, 29, 387 (1985), Kamath, B., et al.: J. Pharm. Biomed. Anal., 11, 407 (1993), Chankvetadze, B., et al.: J. Pharm. Biomed. Anal., 27, 161 (2002),

Applications Ethyl Deoxycholate is the ethyl ester of the common bile salt Deoxycholic Acid (D232645), a Cholic Acid (C432600) derivative used as a component in cell lysis buffers.
References Tuangtong, R. et al.: Dermatol. Surg., 36, 899 (2010); Araki, Y. et al.: Scand. J. Gast., 36, 533 (2001);

Applications 4-Hydroxy Propofol sulfate sodium salt is a derivative of Propofol, a hypnotic intravenous agent that is commonly used as an anasthetic for conscious sedation.
References GüLCIN, I., et al.: Chem. Pharm. Bull., 53, 281 (2005); Koshy, G., et al.: Am. J. Gastroenterol., 95, 1476 (2000)

Applications It is used as cholesterol-lowering agent.
References Bauer, D., et al.: Polym Deg. Stab., 48, 259 (1995), Nakahara, K., et al.: Chem. Physics Lett., 359, 351 (2002),

Applications 8-Bromo-2’-deoxyguanosine (cas# 13389-03-2) is a compound useful in organic synthesis.
References Chatgilialoglu, C., et al.: Chem. Res. Toxicol., 20, 1820 (2007),

Impurity Betamethasone Dipropionate EP Impurity J
Applications Betamethasone 9,11-Epoxide 17,21-Dipropionate (Betamethasone Dipropionate EP Impurity F) is an impurity of Betamethasone (B327000), an antiinflammatory agent.
References Shou, M., et al.: J. Pharm. Biomed. Anal., 50, 356 (2009),

Applications: N,N'-Di(2-hydroxybenzyl)ethylenediamine-N,N'-diacetic Acid Monohydrochloride Hydrate is a component for treating or preventing obesity and insulin resistance and mitrochondrial-associated disorders.N,N'-Di(2-hydroxybenzyl)ethylenediamine-N,N'-diacetic Acid Monohydrochloride Hydrate is also the monohydrochloride hydrate of HBED (H107503), which is an iron chelator useful in treating iron overload.
References Milburn, Michael, WO 2007008548, (2007)Bergeron, Raymond J., WO 9939706, (1999)

Applications Betamethasone 17-Butyrate is an impurity of Clobetasone 17-Butyrate (C583550), an glucocorticoid used for anti-inflammatory purposes.

Applications Methyl Lithocholate is an derivative of Lithocholic Acid (L469180),a cholic acid derivative as TGR5 modulator. Found in ox bile, human bile, rabbit bile, and in ox and pig gallstones.
References Roleira, F.M., et al.: Lett. Drug. Design. Discovery., 7, 610 (2010);

Applications cis-Etoposide is an anticancer agent that has half-life of 2 days at pH 7.4 and 37° resulting in the loss of 90% of the active drug within 1 week during in vitro incubations.
References Mader, R. M., et al.: Cancer Chemotherapy and Pharmacol., 27, 354 (1991)

Applications 2',7'-Difluorofluorescein is a reactant used in the synthesis of biarsenical probes that inhibit protein tyrosine phosphatases.
References Pomorski, A., et. al.: Org. Biomol. Chem., 13, 1395 (2015)

Impurity Nicardipine USP Related Compound B
Applications A pyridine metabolite M-5 of Nicardipine. Nicardipine USP Related Compound B.
Not a dangerous good if item is equal to or less than 1g/ml and there is less than 100g/ml in the package
References Triggle, A., et al.: J. Med. Chem., 23, 1442 (1980), Freedman, D., et al.: Drugs, 34, 578 (1987), Guengerich, F., et al.: Xenobiotica, 25, 689 (1995), Schleifer, K., et al.: Pharmazie, 54, 804 (1999),

Stability Light Sensitive
Applications Ciprofibrate Ethyl Ester is an impurity of ciprofibrate(C482475) is a hypolipemic agent, related structurally to Clofibrate (C586910). Ciprofibrate is used as an antilipemic.
References Davison, C., et al.: Drug. Metab. Dispos., 3, 520 (1975), Arnold, A., et al.: J. Pharm. Sci., et al.: 68, 1557 (1979), Tuchman-Duplessis, H., et al.: Toxicology, 12, 1 (1979),

Applications 19-Norandrosterone is the oxidized byproduct of Nandrolone (N315000), an anabolic steroid that is present naturally in the human body.
References Jiang, J.Q., et al.: J. Food. Sci., 77, 63 (2012); Delgadillo, M.A., et al.: J. Chromatograph. Anal. Technol. Biomed. Life. Sci., 897 (2012);

Applications Atorvastatin (A791750) impurity.
References Kearney, A.S., et al.: Pharm. Res., 10, 1461 (1993); Heinonen, T.M., et al.: Clin. Ther., 18, 853 (1996);

Applications N-(Phenyl)-2-naphthylamine is a reagent in the preparation of unsymmetrical triaryldiamines as thermally stable hole transport layers for various organic LEDs.
References Koene, B. et al.: Chem. Mat., 10, 2235 (1998)

Applications 6-Hydroxy Bromantane is a metabolite of Bromantane (B678450).
References Bi, H., et al.: J. Steroid Biochem. Mol. Biol., 42, 229 (1992), Pozo, O., et al.: Anal. Bioanal. Chem., 389, 1209 (2007), Kiousi, P., et al.: Bioanalysis, 1, 1209 (2009),

Stability Hygroscopic
Applications An intermediate in the production of Rosuvastatin (R700500) derivatives.

Applications The major metabolite of Deflazacort.
References Bernareggi, A., et al.: J. Pharma. Biomed. Anal., 5, 177-81 (1987), Assandri, A., et al.: Xenobiotica, 13(3), 185 (1983), Martinelli, E., et al.: Drug Metab. Dispos., 7, 335 (1979),

Applications A metabolite of Digoxin (Dx) (D446575).
Not a dangerous good if item is equal to or less than 1g/ml and there is less than 100g/ml in the package
References Fujii, Y., et al.: Clin. Chem., 37, 476 (1991), Salphati, L., et al.: Xenobiotica, 29, 171 (1999), Song, S., et al.: Drug Metab. Dispos., 27, 689 (1999),

Impurity Ethinylestradiol EP Impurity H
Applications A degradation product of Ethynyl Estradiol (EE), (E685100).
Not a dangerous good if item is equal to or less than 1g/ml and there is less than 100g/ml in the package

Applications Edoxaban is an anticoagulant drug which acts as a direct factor Xa inhibitor.
References Ruff, C., et al.: Am. Heart J., 160, 635 (2010); Ogata, K., et al.: J. Clin. Pharm., 50, 73 (2010)

Applications Aprindine is a long-acting antiarrhythmic agent, effective when administered orally or intravenously in the treatment of ventricular arrhythmias of varying etiologies.
References Danilo, P. Jr., et al.: Am. Heart. J., 97, 119 (1979); Atarashi, H., et al.: Circulation. J., 66, 553 (2002);

Applications An intermediate for the synthesis of Diclofenac’s glucuronide metaoblite.
Not a dangerous good if item is equal to or less than 1g/ml and there is less than 100g/ml in the package
References Kenny, J.R., et al.: J. Med. Chem., 47, 2816 (2004),

Applications A metabolite of Baclofen (c).
References Ault, B., et al.: Eur. J. Pharmacol., 71, 357 (1981),

Applications Labelled Ouabain (O714500). A cardiac glycoside that inhibits Na(+)/K(+) ATPase. It regulates transcription of MDR (increase, Pgp) and MRP (increase MRP1 and decrease CFTR, cyctic fibrosis transport receptor or cAMP-activated Cl- channel) genes, also alters localization of MRP1.
Not a dangerous good if item is equal to or less than 1g/ml and there is less than 100g/ml in the package
References Padilha, A.S. et al.: Clin. Exp. Pharmacol. Physiol., 35, 801 (2008); Blaustein, M.P. et al.: Clin. Exp. Hypertens. 20, 691 (1998); van Huysse, J.W. et al.: Clin. Exp. Hypertens. 20, 657 (1998);

Applications Potassium bromide is an ionic compound that is commonly used in chemistry to form a pellet that can be used to analyze a number of compounds by means of infrared spectroscopy. Potassium bromide is also used as an anticonvulsant to treat refractory seizures in humans and dogs.
References Kirkland, J.: Anal. Chem., 27, 1537 (1955); Korinthenberg, R., et al.: J. Child Neuro., 22, 414 (2007); Wilberley, S., et al.: Anal. Chem., 29, 210 (1957); Yohn, S., et al.: J. Am. Vet. Med. Ass., 201, 468 (1992)

Applications A metabolite of Benzydamine (B209950).
References Kataoka, S., et al.: Chem. Pharma. Bull., 21, 358 (1973),

Stability Hygroscopic
Applications Troglitazone Sulfate is the major metabolite of Troglitazone (T892500), a hypoglycemic agent with cholestatic effect.
References Ciaraldi, T.P., et al.: Metabolism, 39, 1056 (1990); Kuzuya, T., et al.: Diabetes Res. Clin. Pract., 11, 147 (1991); Kellerer, M., et al.: Diabetes, 43, 447 (1994); Adachi, Y., et al.: Mol. Pharmacol., 67, 923 (2005);

Applications Rosuvastatin Methyl Ester is an impurity of Rosuvastatin (R700500) in the pharmaceutical dosage forms under forced degradation conditions.
References Lennernas, H., et al.: Clin. Pharmacokinet., 32, 403 (1997), Kivisto, K., et al.: Br. J. Clin. Pharmacol., 46, 49 (1998), Lan, K., et al.: J. Pharm. Biomed. Anal., 44, 540 (2007),