Sildenafil Impurity 67 CAS 3312-58-1

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.3312-58-1
Molecular FormulaC6H14N2O2
Molecular Weight146.19 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Sildenafil Impurity 67 CAS 3312-58-1 chemical structure

Description

Sildenafil Impurity 67 (CAS 3312-58-1) is a certified pharmaceutical impurity reference standard with the molecular formula C6H14N2O2 and a molecular weight of 146.19 g/mol.

Owing to an amino-acid-derived structure, an amide group, a hydroxyl group, an ether linkage, Sildenafil Impurity 67 is typically white to off-white liquid. Its solid-state physicochemical attributes — including a molecular weight of 146.19 g/mol — guide the selection of appropriate sample preparation and analytical techniques. Nitrogen-containing functional groups confer excellent ionization efficiency in positive-ion electrospray (ESI) mode, making the compound well suited to LC-MS/MS analysis.

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 FormulaC6H14N2O2
Molecular Weight146.19 g/mol
Purity>95%
StorageStore at 2-8°C, protect from light, keep sealed and dry
Solubility (reference)Soluble in DMSO, DMF, methanol
StabilityLight-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening
Degree of Unsaturation (DBE)1.0
CAS Registry Year (est.)1957
Nitrogen Atoms2

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