Lurasidone Impurity 12 CAS 1807607-99-3

Purity >90%In StockPharmacopoeial Impurity Standards
CAS No.1807607-99-3
Molecular FormulaC28H36N4O4S
Molecular Weight524.67 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Lurasidone Impurity 12 CAS 1807607-99-3 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 Lurasidone Impurity 12.

Lurasidone Impurity 12 (CAS 1807607-99-3) is a certified pharmaceutical impurity reference standard with the molecular formula C28H36N4O4S and a molecular weight of 524.67 g/mol.

Owing to a steroid core, an amide group, a sulfone group, a hydroxyl group, an ether linkage, Lurasidone Impurity 12 is typically pale yellow to yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 524.67 g/mol — guide the selection of appropriate sample preparation and analytical techniques. 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 FormulaC28H36N4O4S
Molecular Weight524.67 g/mol
Purity>90%
StorageStore in a cool place (≤25°C), protect from light, keep sealed and dry
Solubility (reference)Soluble in DMSO, DMF, methanol
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening
Degree of Unsaturation (DBE)13.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1995
Nitrogen Atoms4
Sulfur Atoms1

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