Amorolfine Impurity 41 CAS 5445-77-2

Purity ＞95%In StockPharmacopoeial Impurity Standards
CAS No.5445-77-2
Molecular FormulaC10H12O
Molecular Weight148.20 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Amorolfine Impurity 41 CAS 5445-77-2 chemical structure

Description

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.

Amorolfine Impurity 41 (CAS 5445-77-2) is a certified pharmaceutical impurity reference standard with the molecular formula C10H12O and a molecular weight of 148.20 g/mol.

Structurally, Amorolfine Impurity 41 (C10H12O) contains a hydroxyl group, an ether linkage, an aromatic ring system. The molecule exhibits a degree of unsaturation (DBE) of 5.0, corresponding to approximately 5 ring(s) or double-bond equivalent(s). With a molecular weight of 148.20 g/mol, it falls into the low-molecular-weight range. 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.

Physical & Chemical Properties

Molecular FormulaC10H12O
Molecular Weight148.20 g/mol
Purity＞95%
StorageStore at 2-8°C
Solubility (reference)Soluble in chloroform, dichloromethane, ethyl acetate, DMSO
StabilityStable under recommended storage conditions
Degree of Unsaturation (DBE)5.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1958

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