(3R)-Tryptophan EP Impurity I (Mixture of Diastereomers) CAS 827304-63-2

Description

Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including (3R)-Tryptophan EP Impurity I (Mixture of Diastereomers).

(3R)-Tryptophan EP Impurity I (Mixture of Diastereomers) (CAS 827304-63-2) is a certified pharmaceutical impurity reference standard with the molecular formula C13H14N2O2 and a molecular weight of 230.26 g/mol.

Based on its molecular formula C13H14N2O2, (3R)-Tryptophan EP Impurity I (Mixture of Diastereomers) contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 230.26 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).

This reference standard supports related-substances testing and method development in line with ICH Q3A/Q3B guidance on impurity control, and is suitable for system suitability testing and forced-degradation studies.

The assigned purity is verified by mass-balance and quantitative NMR (qNMR) approaches, with the expanded uncertainty reported at a 95% confidence level (k=2). Batch homogeneity and stability are independently assessed for every lot.

Physical & Chemical Properties

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