Theophylline EP Impurity C CAS 7597-60-6

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.7597-60-6
Molecular FormulaC7H10N4O3
Molecular Weight198.18 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Theophylline EP Impurity C CAS 7597-60-6 chemical structure

Description

The occurrence of Theophylline EP Impurity C is closely related to an amino-acid-derived structure, an amide group, a hydroxyl group, an ether linkage in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

CATO supplies Theophylline EP Impurity C (CAS 7597-60-6), a pharmacopoeial impurity reference standard (molecular formula C7H10N4O3, MW 198.18 g/mol) used for the identification and quantification of trace impurities in APIs.

The molecular framework of Theophylline EP Impurity C (C7H10N4O3) is characterized by an amino-acid-derived structure, an amide group, a hydroxyl group, an ether linkage. In reversed-phase chromatography, its retention is governed primarily by the protonation state of its nitrogen-containing groups, which provides a practical basis for HPLC-UV/DAD or LC-MS method development. 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

Molecular FormulaC7H10N4O3
Molecular Weight198.18 g/mol
AppearanceOff-white to pale yellow crystalline powder. (faint amine-like odor)
Purity>95%
StorageStore at 2-8°C, protect from light, keep sealed and dry
Solubility (reference)Soluble in methanol, ethanol, DMSO, water
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening
Degree of Unsaturation (DBE)5.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1959
Nitrogen Atoms4

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