Alanyl Glutamine Impurity 43 CAS CATO-C4X-197443

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-197443
Molecular FormulaC7H10N2O4
Molecular Weight186.17 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Alanyl Glutamine Impurity 43 CAS CATO-C4X-197443 chemical structure

Description

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.

Alanyl Glutamine Impurity 43 (CAS CATO-C4X-197443) is a certified pharmaceutical impurity reference standard with the molecular formula C7H10N2O4 and a molecular weight of 186.17 g/mol.

The molecular framework of Alanyl Glutamine Impurity 43 (C7H10N2O4) is characterized by an amino-acid-derived structure, an amide group, a hydroxyl group, an ether linkage. In reversed-phase chromatography, its retention is governed primarily by the protonation state of its nitrogen-containing groups, which provides a practical basis for HPLC-UV/DAD or LC-MS method development. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).

As a certified reference material (CRM), Alanyl Glutamine Impurity 43 meets the metrological traceability requirements of ISO/IEC 17025 laboratories. Batch-to-batch consistency is monitored via control charts to guarantee comparable assigned values across lots.

Physical & Chemical Properties

Molecular FormulaC7H10N2O4
Molecular Weight186.17 g/mol
AppearanceOff-white to pale yellow crystalline powder. (faint amine-like odor)
Purity>95%
StorageStore at 2-8°C, protect from light, keep sealed and dry
Solubility (reference)Soluble in methanol, ethanol, DMSO, water
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening
Degree of Unsaturation (DBE)4.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Nitrogen Atoms2

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