Sodium Cromoglicate Impurity 13 CAS 53878-47-0

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.53878-47-0
Molecular FormulaC10H6O5
Molecular Weight206.15 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Sodium Cromoglicate Impurity 13 CAS 53878-47-0 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.

Sodium Cromoglicate Impurity 13 (CAS 53878-47-0) is a certified pharmaceutical impurity reference standard with the molecular formula C10H6O5 and a molecular weight of 206.15 g/mol.

Structurally, Sodium Cromoglicate Impurity 13 (C10H6O5) contains a carboxylic acid group, a hydroxyl group, an ether linkage, an aromatic ring system. The molecule exhibits a degree of unsaturation (DBE) of 8.0, corresponding to approximately 8 ring(s) or double-bond equivalent(s). With a molecular weight of 206.15 g/mol, it falls into the medium-molecular-weight range. 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 FormulaC10H6O5
Molecular Weight206.15 g/mol
AppearancePale yellow to yellow crystalline powder
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)8.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1972

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