Levothyroxine N-Acetyl Impurity CAS 26041-51-0

Purity >90%In StockPharmacopoeial Impurity Standards
CAS No.26041-51-0
Molecular FormulaC17H13I4NO5
Molecular Weight818.91 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Levothyroxine N-Acetyl Impurity CAS 26041-51-0 chemical structure

Description

Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Levothyroxine N-Acetyl Impurity.

CATO supplies Levothyroxine N-Acetyl Impurity (CAS 26041-51-0), a pharmacopoeial impurity reference standard (molecular formula C17H13I4NO5, MW 818.91 g/mol) used for the identification and quantification of trace impurities in APIs.

The molecular framework of Levothyroxine N-Acetyl Impurity (C17H13I4NO5) is characterized by a flavonoid core, an amide group, a hydroxyl group, an ether linkage, iodine substitution. In reversed-phase chromatography, its retention is governed primarily by the protonation state of its nitrogen-containing groups, which provides a practical basis for HPLC-UV/DAD or LC-MS method development. Nitrogen-containing functional groups confer excellent ionization efficiency in positive-ion electrospray (ESI) mode, making the compound well suited to LC-MS/MS analysis.

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.

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.

Physical & Chemical Properties

Molecular FormulaC17H13I4NO5
Molecular Weight818.91 g/mol
Purity>90%
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)10.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1964
Halogen ContentI-containing
Nitrogen Atoms1

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