Indometacin EP Impurity H CAS 1601-18-9

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.1601-18-9
Molecular FormulaC20H18ClNO4
Molecular Weight371.81 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Indometacin EP Impurity H CAS 1601-18-9 chemical structure

Description

Indometacin EP Impurity H (CAS 1601-18-9) is a certified pharmaceutical impurity reference standard with the molecular formula C20H18ClNO4 and a molecular weight of 371.81 g/mol.

Owing to a flavonoid core, an amide group, a hydroxyl group, an ether linkage, chlorine substitution, Indometacin EP Impurity H is typically pale yellow to yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 371.81 g/mol — guide the selection of appropriate sample preparation and analytical techniques. Halogen substitution (F/Cl/Br/I) produces a distinctive isotope pattern in mass spectrometry, a valuable aid for qualitative confirmation.

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 Indometacin EP Impurity H 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 FormulaC20H18ClNO4
Molecular Weight371.81 g/mol
AppearancePale yellow to yellow crystalline powder. (slight halide-like odor)
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; Contains ester bond; hydrolyzes under strong alkaline conditions
Degree of Unsaturation (DBE)12.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1957
Halogen ContentCl-containing
Nitrogen Atoms1

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