Carglumic Acid impurity 8 CAS 45214-91-3

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.45214-91-3
Molecular FormulaC11H19NO6
Molecular Weight261.27 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Carglumic Acid impurity 8 CAS 45214-91-3 chemical structure

Description

Compared with other compounds in its class, the molecular weight of 261.27 g/mol gives Carglumic Acid impurity 8 distinctive chromatographic separation conditions and mass-spectrometry parameter settings.

As a process- or degradation-related impurity, Carglumic Acid impurity 8 (CAS 45214-91-3, C11H19NO6) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Owing to an amino-acid-derived structure, an amide group, a hydroxyl group, an ether linkage, Carglumic Acid impurity 8 is typically white to pale yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 261.27 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.

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 FormulaC11H19NO6
Molecular Weight261.27 g/mol
AppearanceWhite to pale yellow crystalline powder
Purity97%+
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)3.0
UV AbsorptionUV-absorbing
CAS Registry Year (est.)1969
Nitrogen Atoms1

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