Methylene blue Impurity 4 CAS CATO-C4X-18964

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-18964
Molecular FormulaC12H7INS
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Methylene blue Impurity 4 CAS CATO-C4X-18964 chemical structure

Description

As a process- or degradation-related impurity, Methylene blue Impurity 4 (CAS CATO-C4X-18964, C12H7INSI) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

The molecular framework of Methylene blue Impurity 4 (C12H7INSI) is characterized by a nitrogen-containing heterocyclic scaffold, a nitrile group, sulfur-containing functionality, iodine substitution. In reversed-phase chromatography, its retention is governed primarily by its high hydrophobicity (logP), which provides a practical basis for HPLC-UV/DAD or LC-MS method development. 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.

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 FormulaC12H7INS I
Molecular Weight451.06 g/mol
Purity>95%
StorageStore at room temperature, protect from light
Solubility (reference)Soluble in chloroform, dichloromethane, ethyl acetate
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light
Degree of Unsaturation (DBE)9.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Halogen ContentI-containing
Nitrogen Atoms1
Sulfur Atoms1

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