Ganciclovir EP Impurity H CAS 84222-50-4

Purity >80%In StockPharmacopoeial Impurity Standards
CAS No.84222-50-4
Molecular FormulaC9H13N5O4
Molecular Weight255.23 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Ganciclovir EP Impurity H CAS 84222-50-4 chemical structure

Description

Ganciclovir EP Impurity H (CAS 84222-50-4) is a certified pharmaceutical impurity reference standard with the molecular formula C9H13N5O4 and a molecular weight of 255.23 g/mol.

Owing to an amino-acid-derived structure, an amide group, a hydroxyl group, an ether linkage, Ganciclovir EP Impurity H is typically off-white to pale yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 255.23 g/mol — guide the selection of appropriate sample preparation and analytical techniques. The presence of an aromatic ring or conjugated system gives the compound characteristic absorption bands in the UV-Vis region, making it well suited to UV or diode-array detection (DAD).

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.

As a certified reference material (CRM), Ganciclovir EP Impurity H meets the metrological traceability requirements of ISO/IEC 17025 laboratories. Batch-to-batch consistency is monitored via control charts to guarantee comparable assigned values across lots.

Physical & Chemical Properties

Molecular FormulaC9H13N5O4
Molecular Weight255.23 g/mol
AppearanceOff-white to pale yellow crystalline powder. (faint amine-like odor)
Purity>80%
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

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