Launch of new USP Pharmacopeia product category: API Impurities

15 December 2021

The United States Pharmacopeia (USP) has launched a new product range: a list of API impurities to facilitate to those responsible for quality control or R&D of medicines or their ingredients to check whether their products are within the predefined parameters.

The API impurities are to be used mainly for the following applications:

Conducting tests in formulation feasibility studies.
Identification or confirmation of peaks, comparing retention times or spectra results
Determination of degradation impurities produced during stress studies or formed during ICH stability testing.
Development, validation and transfer of analytical methods.

These are the API impurities already available for purchase on the CymitQuimica website:
[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)

This list of impurities, along with the official USP reference standards, results in a comprehensive catalogue in the field of lab analytics and research.