Levothyroxine EP Impurity B CAS 1628720-66-0

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.1628720-66-0
Molecular FormulaC15H11ClI3NO4
Molecular Weight685.42 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Levothyroxine EP Impurity B CAS 1628720-66-0 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.

Levothyroxine EP Impurity B (CAS 1628720-66-0) is a certified pharmaceutical impurity reference standard with the molecular formula C15H11ClI3NO4 and a molecular weight of 685.42 g/mol.

Structurally, Levothyroxine EP Impurity B (C15H11ClI3NO4) contains a flavonoid core, an amide group, a hydroxyl group, an ether linkage, chlorine/iodine substitution. The molecule exhibits a degree of unsaturation (DBE) of 9.0, corresponding to approximately 9 ring(s) or double-bond equivalent(s). With a molecular weight of 685.42 g/mol, it falls into the high-molecular-weight range. 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.

Physical & Chemical Properties

Molecular FormulaC15H11ClI3NO4
Molecular Weight685.42 g/mol
Purity>95%
StorageStore at room temperature, 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)9.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1993
Halogen ContentCl/I-containing
Nitrogen Atoms1

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