Lovastatin Impurity 38 CAS CATO-C4X-168438

Purity 95%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-168438
Molecular FormulaC13H29N
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Lovastatin Impurity 38 CAS CATO-C4X-168438 chemical structure

Description

As a certified reference material (CRM), Lovastatin Impurity 38 meets the metrological traceability requirements of ISO/IEC 17025 laboratories. Batch-to-batch consistency is monitored via control charts to guarantee comparable assigned values across lots.

As a process- or degradation-related impurity, Lovastatin Impurity 38 (CAS CATO-C4X-168438, C13H29NC7H16C5H12C2H6) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

The molecular framework of Lovastatin Impurity 38 (C13H29NC7H16C5H12C2H6) is characterized by an organic framework. 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. 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.

Physical & Chemical Properties

Molecular FormulaC13H29N C7H16 C5H12 4*C2H6
Molecular Weight401.81 g/mol
Purity95%
StorageStore at room temperature, protect from light
Solubility (reference)Soluble in chloroform, dichloromethane, ethyl acetate
StabilityLight-sensitive; avoid direct strong light
Degree of Unsaturation (DBE)-3.0
Nitrogen Atoms1

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