New Drug Impurity 63 D5 CAS CATO-C3D-262963

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C3D-262963
Molecular Formula-
Molecular Weight627.83 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

New Drug Impurity 63 D5 CAS CATO-C3D-262963 chemical structure

Description

Recommended for quantitative analysis by HPLC, GC, LC-MS/MS, or GC-MS as an external calibration standard; it can also be used for spiked-recovery experiments, LOD/LOQ determination, and LC-MS/MS multiple-reaction-monitoring (MRM) calibration.

As a process- or degradation-related impurity, New Drug Impurity 63 D5 (CAS CATO-C3D-262963, C34H45D5N6O5) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Owing to deuterium isotope labeling, a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, New Drug Impurity 63 D5 is typically pale yellow to yellow amorphous powder. Its solid-state physicochemical attributes — including a molecular weight of 627.83 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).

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 FormulaC34H45D5N6O5
Molecular Weight627.83 g/mol
Purity97%+
StorageStore in a cool place (≤25°C), protect from light, keep sealed and dry
Solubility (reference)Soluble in DMSO, DMF, methanol
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening
Degree of Unsaturation (DBE)15.5
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Nitrogen Atoms6

Recommended Standards

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