Dorzagliatin Impurity 10 CAS CATO-C4X-344110

Purity ≥95%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-344110
Molecular FormulaC9H13N3O4
Molecular Weight227.22 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Dorzagliatin Impurity 10 CAS CATO-C4X-344110 chemical structure

Description

Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Dorzagliatin Impurity 10.

Dorzagliatin Impurity 10 (CAS CATO-C4X-344110) is a certified pharmaceutical impurity reference standard with the molecular formula C9H13N3O4 and a molecular weight of 227.22 g/mol.

Based on its molecular formula C9H13N3O4, Dorzagliatin Impurity 10 contains an amino-acid-derived structure, an amide group, a hydroxyl group, an ether linkage; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 227.22 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. Nitrogen-containing functional groups confer excellent ionization efficiency in positive-ion electrospray (ESI) mode, making the compound well suited to LC-MS/MS analysis.

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.

As a certified reference material (CRM), Dorzagliatin Impurity 10 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 FormulaC9H13N3O4
Molecular Weight227.22 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
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening
Degree of Unsaturation (DBE)5.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Nitrogen Atoms3

Related Dorzagliatin Standards

Recommended Standards

Why CATO?