Ergotamine Impurity 5 CAS 4238-84-0

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.4238-84-0
Molecular FormulaC18H21N3O
Molecular Weight295.38 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Ergotamine Impurity 5 CAS 4238-84-0 chemical structure

Description

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.

Ergotamine Impurity 5 (CAS 4238-84-0) is a certified pharmaceutical impurity reference standard with the molecular formula C18H21N3O and a molecular weight of 295.38 g/mol.

Ergotamine Impurity 5 (C18H21N3O) contains a steroid core, an amide group, a hydroxyl group, an ether linkage. Its high carbon-to-hydrogen ratio confers good lipid solubility; these physicochemical properties determine the optimal preparation and storage of its standard solutions. The high carbon-to-hydrogen ratio imparts good lipophilicity, allowing liquid-liquid extraction with non-polar solvents such as n-hexane or ethyl acetate.

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 FormulaC18H21N3O
Molecular Weight295.38 g/mol
AppearancePale yellow to yellow crystalline powder
Purity>95%
StorageStore at 2-8°C, protect from light
Solubility (reference)Soluble in DMSO, DMF, methanol
StabilityLight-sensitive; avoid direct strong light
Degree of Unsaturation (DBE)10.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1958
Nitrogen Atoms3

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