Pilocarpine Impurity 18 CAS CATO-C4X-240118

Purity ≥95%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-240118
Molecular FormulaC11H16N2O3
Molecular Weight224.26 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Pilocarpine Impurity 18 CAS CATO-C4X-240118 chemical structure

Description

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.

CATO supplies Pilocarpine Impurity 18 (CAS CATO-C4X-240118), a pharmacopoeial impurity reference standard (molecular formula C11H16N2O3, MW 224.26 g/mol) used for the identification and quantification of trace impurities in APIs.

Pilocarpine Impurity 18 (C11H16N2O3) 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 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.

Physical & Chemical Properties

Molecular FormulaC11H16N2O3
Molecular Weight224.26 g/mol
AppearanceOff-white to pale yellow crystalline powder
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 Atoms2

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