Insulin Degludec Impurity 26 CAS CATO-C4X-215726

Purity ≥95%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-215726
Molecular FormulaC25H45NO7
Molecular Weight471.63 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Insulin Degludec Impurity 26 CAS CATO-C4X-215726 chemical structure

Description

Compared with other compounds in its class, the molecular weight of 471.63 g/mol gives Insulin Degludec Impurity 26 distinctive chromatographic separation conditions and mass-spectrometry parameter settings.

As a process- or degradation-related impurity, Insulin Degludec Impurity 26 (CAS CATO-C4X-215726, C25H45NO7) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Insulin Degludec Impurity 26 (C25H45NO7) contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage. The carboxyl group imparts weak acidity; these physicochemical properties determine the optimal preparation and storage of its standard solutions. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).

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.

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 FormulaC25H45NO7
Molecular Weight471.63 g/mol
AppearanceOff-white to pale yellow crystalline powder
Purity≥95%
StorageStore at room temperature, protect from light, keep sealed and dry
Solubility (reference)Soluble in methanol, acetonitrile, DMSO, water (slightly soluble)
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light
Degree of Unsaturation (DBE)4.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Nitrogen Atoms1

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