Miglitol Impurity 8 CAS CATO-C4X-16978

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-16978
Molecular FormulaC8H11NO2
Molecular Weight153.18 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Miglitol Impurity 8 CAS CATO-C4X-16978 chemical structure

Description

Compared with other compounds in its class, the molecular weight of 153.18 g/mol gives Miglitol Impurity 8 distinctive chromatographic separation conditions and mass-spectrometry parameter settings.

Miglitol Impurity 8 (CAS CATO-C4X-16978) is a certified pharmaceutical impurity reference standard with the molecular formula C8H11NO2 and a molecular weight of 153.18 g/mol.

The molecular framework of Miglitol Impurity 8 (C8H11NO2) 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).

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), Miglitol Impurity 8 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 FormulaC8H11NO2
Molecular Weight153.18 g/mol
AppearanceOff-white to pale yellow crystalline powder. (faint amine-like odor)
Purity97%+
StorageStore at 2-8°C, protect from light
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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