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Includes: HPLC, MASS/LC-MS, 1H NMR, FT-IR, Potency, Structure Elucidation Report (SER), and additional analytical data depending on the product.

1008-35-1Tetrahydrobiopterin Impurity 2

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Catalogue No.:	VE0026126
CAS No.:	1008-35-1
Mol. Formula:	C6H9N5O
Mol. Weight:	167.17 g/mol

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Additional information on CAS 1008-35-1

Parent drug

Sapropterin

IUPAC Name

2-amino-5,6,7,8-tetrahydropteridin-4-ol

Smiles

NC1=NC(O)=C2NCCNC2=N1

InChI

InChI=1S/C6H9N5O/c7-6-10-4-3(5(12)11-6)8-1-2-9-4/h8H,1-2H2,(H4,7,9,10,11,12)

Description

Tetrahydrobiopterin Impurity 2 (CAS 1008-35-1) is a process-related and degradation impurity encountered during synthesis and storage of tetrahydrobiopterin. It exhibits distinct chromatographic retention and a characteristic LC-MS fragmentation pattern that facilitates targeted trace-level quantification. Structural elucidation by NMR confirms substitution patterns responsible for altered redox behavior, increasing susceptibility to oxidative conversion under acidic or basic conditions. Control strategies include solvent selection, pH optimization, incorporation of antioxidants, and in-process purification to limit formation. Routine HPLC and LC-MS monitoring, method validation for sensitivity, and specification setting are recommended to ensure impurity qualification per regulatory expectations and to maintain product quality.