Meglumine impurity 8 CAS 24758-59-6

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.24758-59-6
Molecular FormulaC7H15NO6
Molecular Weight209.20 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Meglumine impurity 8 CAS 24758-59-6 chemical structure

Description

The occurrence of Meglumine impurity 8 is closely related to a carbohydrate-derived structure, an amide group in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

As a process- or degradation-related impurity, Meglumine impurity 8 (CAS 24758-59-6, C7H15NO6) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

The molecular framework of Meglumine impurity 8 (C7H15NO6) is characterized by a carbohydrate-derived structure, an amide group. 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. 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.

CATO manufactures Meglumine impurity 8 under ISO 17034:2016 accreditation with dual CNAS and ANAB accreditation. Each batch is characterized by orthogonal methods and supplied with a full Certificate of Analysis (COA), ensuring metrological traceability.

Physical & Chemical Properties

Molecular FormulaC7H15NO6
Molecular Weight209.20 g/mol
Purity97%+
StorageStore at 2-8°C, protect from light, keep sealed and dry
Solubility (reference)Soluble in methanol, ethanol, DMSO, water
StabilityLight-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening
Degree of Unsaturation (DBE)1.0
CAS Registry Year (est.)1964
Nitrogen Atoms1

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