Ganciclovir EP Impurity E CAS 86357-09-7

Purity >90%In StockPharmacopoeial Impurity Standards
CAS No.86357-09-7
Molecular FormulaC9H13N5O4
Molecular Weight255.23 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Ganciclovir EP Impurity E CAS 86357-09-7 chemical structure

Description

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.

Ganciclovir EP Impurity E (CAS 86357-09-7) is a certified pharmaceutical impurity reference standard with the molecular formula C9H13N5O4 and a molecular weight of 255.23 g/mol.

Based on its molecular formula C9H13N5O4, Ganciclovir EP Impurity E contains an amino-acid-derived structure, an amide group, a hydroxyl group, an ether linkage; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 255.23 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).

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 FormulaC9H13N5O4
Molecular Weight255.23 g/mol
AppearanceOff-white to pale yellow crystalline powder. (faint amine-like odor)
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
Degree of Unsaturation (DBE)6.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1981
Nitrogen Atoms5

Related Ganciclovir Standards

Recommended Standards

Why CATO?