Mesalazine Impurity 21 CAS 51-59-2

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.51-59-2
Molecular FormulaC9H9NO4
Molecular Weight195.17 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Mesalazine Impurity 21 CAS 51-59-2 chemical structure

Description

Compared with other compounds in its class, the molecular weight of 195.17 g/mol gives Mesalazine Impurity 21 distinctive chromatographic separation conditions and mass-spectrometry parameter settings.

Mesalazine Impurity 21 (CAS 51-59-2) is a certified pharmaceutical impurity reference standard with the molecular formula C9H9NO4 and a molecular weight of 195.17 g/mol.

Mesalazine Impurity 21 (C9H9NO4) contains an amino-acid-derived structure, an amide group, a hydroxyl group, an ether linkage. It is notably hygroscopic, 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.

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.

Physical & Chemical Properties

Molecular FormulaC9H9NO4
Molecular Weight195.17 g/mol
AppearanceOff-white to pale yellow crystalline powder. (faint amine-like odor)
Purity97%+
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)6.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1957
Nitrogen Atoms1

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