Sapropterin and its Impurities
Sapropterin (BH4, THB), also known as Tetrahydrobiopterin(INN). it is a cofactor used as an adjunct to phenylalanine restriction in the treatment of phenylketonuria (PKU). Reference standards of Sapropterin API, and its pharmacopeial, non pharmacopeial impurities, and stable isotopes are listed below.


(6R)-2-Amino-6-((1R,2S)-1,2-dihydroxypropyl)-7-(hydroxymethyl)-5,6,7,8-tetrahydropteridin-4(3H)-one
(6R)-2-Amino-6-((1R,2S)-1,2-dihydroxypropyl)-7-(hydroxymethyl)-5,6,7,8-tetrahydropteridin-4(3H)-one
Catalogue No.:PA 19 1781007
CAS :
2098644-06-3
Molecular Formula : C10H17N5O4
Molecular Weight : 271.28


2-Amino-6-((1R,2S)-1,2-dihydroxypropyl)-5-nitroso-5,6,7,8-tetrahydropteridin-4(1H)-one Hydrochloride
2-Amino-6-((1R,2S)-1,2-dihydroxypropyl)-5-nitroso-5,6,7,8-tetrahydropteridin-4(1H)-one Hydrochloride
Catalogue No.:PA 19 1781008
CAS :
NA
Molecular Formula : C9H15ClN6O4
Molecular Weight : 306.71


2-Amino-6-((1R,2S)-1,2-dihydroxypropyl)-8-nitroso-5,6,7,8-tetrahydropteridin-4(1H)-one Hydrochloride
2-Amino-6-((1R,2S)-1,2-dihydroxypropyl)-8-nitroso-5,6,7,8-tetrahydropteridin-4(1H)-one Hydrochloride
Catalogue No.:PA 19 1781010
CAS :
NA
Molecular Formula : C9H15ClN6O4
Molecular Weight : 306.71


rel-(R)-2-Amino-6-((1R,2S)-1,2-dihydroxypropyl)-5-nitroso-5,6,7,8-tetrahydropteridin-4(3H)-one
rel-(R)-2-Amino-6-((1R,2S)-1,2-dihydroxypropyl)-5-nitroso-5,6,7,8-tetrahydropteridin-4(3H)-one
Catalogue No.:PA 19 1781018
CAS :
1355024-07-5
Molecular Formula : C9H14N6O4
Molecular Weight : 270.25