Butylphthalide Impurity N4 CAS 168288-19-5

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.168288-19-5
Molecular FormulaC12H14O3
Molecular Weight206.24 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Butylphthalide Impurity N4 CAS 168288-19-5 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 Butylphthalide Impurity N4.

Butylphthalide Impurity N4 (CAS 168288-19-5) is a certified pharmaceutical impurity reference standard with the molecular formula C12H14O3 and a molecular weight of 206.24 g/mol.

Owing to a carboxylic acid group, a hydroxyl group, an ether linkage, an aromatic ring system, Butylphthalide Impurity N4 is typically off-white to pale yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 206.24 g/mol — guide the selection of appropriate sample preparation and analytical techniques. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).

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 FormulaC12H14O3
Molecular Weight206.24 g/mol
AppearanceOff-white to pale yellow crystalline powder
Purity97%+
StorageStore at 2-8°C, protect from light, keep sealed and dry
Solubility (reference)Soluble in chloroform, dichloromethane, ethyl acetate, DMSO
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening
Degree of Unsaturation (DBE)6.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)2005

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