Lovastatin Impurity 21 CAS CATO-C4X-168421

Purity 95%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-168421
Molecular FormulaC18H39N
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Lovastatin Impurity 21 CAS CATO-C4X-168421 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 Lovastatin Impurity 21.

As a process- or degradation-related impurity, Lovastatin Impurity 21 (CAS CATO-C4X-168421, C18H39NC2H6) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Owing to an organic framework, Lovastatin Impurity 21 is typically white to off-white crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 299.59 g/mol — guide the selection of appropriate sample preparation and analytical techniques. The high carbon-to-hydrogen ratio imparts good lipophilicity, allowing liquid-liquid extraction with non-polar solvents such as n-hexane or ethyl acetate.

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 FormulaC18H39N C2H6
Molecular Weight299.59 g/mol
Purity95%
StorageStore at 2-8°C, protect from light
Solubility (reference)Soluble in chloroform, dichloromethane, ethyl acetate
StabilityLight-sensitive; avoid direct strong light
Degree of Unsaturation (DBE)-1.0
Nitrogen Atoms1

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