L-Ornithine L-Aspartate Impurity 22 TFA Salt CAS 1174925-92-8 (free base)

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.1174925-92-8 (free base)
Molecular FormulaC9H17N3O5
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

L-Ornithine L-Aspartate Impurity 22 TFA Salt CAS 1174925-92-8 (free base) chemical structure

Description

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.

L-Ornithine L-Aspartate Impurity 22 TFA Salt (CAS 1174925-92-8 (free base)) is a certified pharmaceutical impurity reference standard with the molecular formula C9H17N3O5C2HF3O2 and a molecular weight of 361.27 g/mol.

L-Ornithine L-Aspartate Impurity 22 TFA Salt (C9H17N3O5C2HF3O2) contains an amide group, a carboxylic acid group, a hydroxyl group, an ether linkage, fluorine substitution. It is notably hygroscopic, halogen substitution raises its density and boiling point, the carboxyl group imparts weak acidity; these physicochemical properties determine the optimal preparation and storage of its standard solutions. 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.

Physical & Chemical Properties

Molecular FormulaC9H17N3O5 C2HF3O2
Molecular Weight361.27 g/mol
AppearanceWhite to pale yellow crystalline powder. (slight halide-like odor, low volatility)
Purity>95%
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; Contains ester bond; hydrolyzes under strong alkaline conditions
Degree of Unsaturation (DBE)3.0
UV AbsorptionUV-absorbing
Halogen ContentF-containing
Nitrogen Atoms3

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