Ketorolac EP Impurity D sodium salt CAS 1391053-45-4 (free base)

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.1391053-45-4 (free base)
Molecular FormulaC16H14NO4
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Ketorolac EP Impurity D sodium salt CAS 1391053-45-4 (free base) chemical structure

Description

The occurrence of Ketorolac EP Impurity D sodium salt is closely related to a flavonoid core, an amide group, a hydroxyl group, an ether linkage in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

Ketorolac EP Impurity D sodium salt (CAS 1391053-45-4 (free base)) is a certified pharmaceutical impurity reference standard with the molecular formula C16H14NO4Na and a molecular weight of 307.28 g/mol.

Owing to a flavonoid core, an amide group, a hydroxyl group, an ether linkage, Ketorolac EP Impurity D sodium salt is typically pale yellow to yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 307.28 g/mol — guide the selection of appropriate sample preparation and analytical techniques. 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), Ketorolac EP Impurity D sodium salt 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 FormulaC16H14NO4 Na
Molecular Weight307.28 g/mol
AppearancePale yellow to yellow crystalline powder
Purity>95%
StorageStore at 2-8°C, protect from light, keep sealed and dry
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)10.5
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Nitrogen Atoms1

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