Lanzamiento nueva categoría productos de la Farmacopea USP: Impurezas de API
La Farmacopea de Estados Unidos (USP) ha lanzado una nueva gama de productos. Se trata de una lista de impurezas de APIque facilita a los responsables de calidad o I+D de medicamentos o sus ingredientes, la comprobación de que sus productos están dentro de los parámetros adecuados.
Las impurezas de APIse pueden usar principalmente para las siguientes aplicaciones:
Llevar a cabo pruebas en estudios de viabilidad de formulación.
Identificación o confirmación de picos, comparando tiempos de retención o resultados de los espectros.
Determinación impurezas de degradación producidas durante estudios de estrés, o bien, que se han formado durante pruebas de estabilidad ICH.
Desarrollo, validación y transferencia de métodos analíticos.
Estas son las impurezas de API disponibles ya para la compra la web de CymitQuimica:
[45-1A00010-25mg] Atorvastatin Ethyl Ester (ethyl (3R,5R)-7-(2-(4-fluorophenyl)-5-isopropyl-3-phenyl-4-(phenylcarbamoyl)-1H-pyrrol-1-yl)-3,5-dihydroxyheptanoate)
[45-1A00020-25mg] Atorvastatin Methyl Ester (methyl (3R,5R)-7-(2-(4-fluorophenyl)-5-isopropyl-3-phenyl-4-(phenylcarbamoyl)-1H-pyrrol-1-yl)-3,5-dihydroxyheptanoate)
[45-1A00030-25mg] Amlodipine Methyl Analog (dimethyl 2-((2-aminoethoxy)methyl)-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate, maleate)
[45-1A00040-25mg] Hydroxythiadiazol Sulfoxide Derivative (4-morpholino-1,2,5-thiadiazol-3(2H)-one 1-oxide)
[45-1A00050-25mg] Rosuvastatin Ketone ((R,E)-7-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)-3-hydroxy-5-oxohept-6-enoic acid)
[45-1A00060-25mg] Desmethoxy Omeprazole (2-(((3,5-dimethylpyridin-2-yl)methyl)sulfinyl)-5-methoxy-1H-benzo[d]imidazole)
[45-1A00070-25mg] 3'-(N,N-Didemethyl)azithromycin; (Aminoazithromycin)
[45-1A00080-25mg] 3'-De(dimethylamino)-3'-oxoazithromycin
[45-1A00090-25mg] Dexamethasone Enol-Pyruvaldehyde Analog ((Z)-2-((8S,9R,10S,11S,13S,14S,16R)-9-fluoro-11-hydroxy-10,13,16-trimethyl-3-oxo-3,6,7,8,9,10,11,12,13,14,15,16-dodecahydro-17H-cyclopenta[a]phenanthren-17-ylidene)-2-hydroxyacetaldehyde)
[45-1A00110-25mg] 6Beta-Hydroxy Ethinyl Estradiol ((6R,8R,9S,13S,14S,17R)-17-ethynyl-13-methyl-7,8,9,11,12,13,14,15,16,17-decahydro-6H-cyclopenta[a]phenanthrene-3,6,17-triol)
[45-1A00120-25mg] Fluoroandrostadiene Carboxylic Acid ((8S,9R,10S,11S,13S,14S,16R,17R)-9-fluoro-11,17-dihydroxy-10,13,16-trimethyl-3-oxo-6,7,8,9,10,11,12,13,14,15,16,17-dodecahydro-3H-cyclopenta[a]phenanthrene-17-carboxylic acid)
[45-1A00140-25mg] R,R,S-Ezetimibe ((3R,4S)-1-(4-fluorophenyl)-3-((R)-3-(4-fluorophenyl)-3-hydroxypropyl)-4-(4-hydroxyphenyl)azetidin-2-one)
[45-1A00150-25mg] Bis(dibenzothiazepinyl) Piperazine (1,4-Bis(dibenzo[b,f][1,4]thiazepin-11-yl)piperazine)
[45-1A00160-25mg] Decarboxy Levofloxacin ((S)-9-fluoro-3-methyl-7-oxo-10-(4-methylpiperazine-1-yl)-2,3-dihydro-7H-pyrido [1,2,3-de] -1,4-benzoxazine)
[45-1A00170-25mg] Rosuvastatin Isoamyl Ester ((3S,5R,6E)-7-[4-(4-flurophenyl)-6-(1-methylethyl)-2-[N-methyl(methylsulphonyl)amino]-5-pyrimidinyI]-3,5-dihydroxy-6-heptanoic acid, methyl butyl ester)
[45-1A00180-25mg] N-Ethyl Quetiapine (11-(4-Ethylpiperazin-1-yl)dibenzo[b,f][1,4]thiazepine hydrochloride)
[45-1A00200-25mg] Amlodipine Ethyl Analog (diethyl 2-((2-aminoethoxy)methyl)-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate, maleate)
[45-1A00210-25mg] 3'-(N,N-Didemethyl)-3'-N-formylazithromycin
[45-1A00240-25mg] o-Celecoxib (4-(5-(o-tolyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl)benzenesulfonamide)
[45-1A00250-25mg] Donepezil quaternary salt (donepezilbenzyl Bromide) (1,1-dibenzyl-4-((5,6-dimethoxy-1-oxo-2,3-dihydro-1H-inden-2-yl)methyl)piperidin-1-ium, bromide)
[45-1A00260-25mg] Azacitidine Formyl Amidine Analog (N-(Formyl amidino)-N'-Beta-D-ribofuranosylurea)
Esta lista de impurezas, junto con los patrones de referencia oficiales de USP, forman un amplio catálogo que abastece las necesidades en los campos de la analítica e investigación.
