Orphenadrine EP Impurity A CAS 5472-13-9

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.5472-13-9
Molecular FormulaC14H14O
Molecular Weight198.26 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Orphenadrine EP Impurity A CAS 5472-13-9 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.

Orphenadrine EP Impurity A (CAS 5472-13-9) is a certified pharmaceutical impurity reference standard with the molecular formula C14H14O and a molecular weight of 198.26 g/mol.

Structurally, Orphenadrine EP Impurity A (C14H14O) contains a hydroxyl group, an ether linkage, a polycyclic aromatic system. The molecule exhibits a degree of unsaturation (DBE) of 8.0, corresponding to approximately 8 ring(s) or double-bond equivalent(s). With a molecular weight of 198.26 g/mol, it falls into the medium-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 FormulaC14H14O
Molecular Weight198.26 g/mol
Purity97%+
StorageStore at 2-8°C, protect from light
Solubility (reference)Soluble in chloroform, dichloromethane, ethyl acetate, DMSO
StabilityLight-sensitive; avoid direct strong light
Degree of Unsaturation (DBE)8.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1958

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