Glutathione EP Impurity D TFA Salt CAS 283159-88-6

Purity >90%In StockPharmacopoeial Impurity Standards
CAS No.283159-88-6
Molecular FormulaC8H14N2O5S
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Glutathione EP Impurity D TFA Salt CAS 283159-88-6 chemical structure

Description

Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Glutathione EP Impurity D TFA Salt.

CATO supplies Glutathione EP Impurity D TFA Salt (CAS 283159-88-6), a pharmacopoeial impurity reference standard (molecular formula C8H14N2O5SC2HF3O2, MW 364.29 g/mol) used for the identification and quantification of trace impurities in APIs.

Glutathione EP Impurity D TFA Salt (C8H14N2O5SC2HF3O2) contains an amide group, a sulfone group, a carboxylic acid group, a hydroxyl group, an ether linkage, fluorine substitution. It is notably hygroscopic, halogen substitution raises its density and boiling point, the carboxyl group imparts weak acidity; these physicochemical properties determine the optimal preparation and storage of its standard solutions. Halogen substitution (F/Cl/Br/I) produces a distinctive isotope pattern in mass spectrometry, a valuable aid for qualitative confirmation.

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

Molecular FormulaC8H14N2O5S C2HF3O2
Molecular Weight364.29 g/mol
Purity>90%
StorageStore at 2-8°C, protect from light, keep sealed and dry
Solubility (reference)Soluble in methanol, ethanol, DMSO
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening; Contains ester bond; hydrolyzes under strong alkaline conditions
Degree of Unsaturation (DBE)3.0
UV AbsorptionUV-absorbing
CAS Registry Year (est.)2025
Halogen ContentF-containing
Nitrogen Atoms2
Sulfur Atoms1

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