Category
Amorolfine
CAS Number
Amorolfine STD-78613-35-1;78613-38-4(HCl Salt): IMP-M-NA
Molecular Formula
Amorolfine STD-C21H35NO: IMP-M-C21H35NO2
Molecular Weight
Amorolfine STD-317.51: IMP-M-333.52
Synonym

Amorolfine STD-(2S,6R)-2,6-dimethyl-4-[2-methyl-3-[4-(2-methylbutan-2-yl)phenyl]propyl]morpholine; 2,6-Dimethyl-4-(2-methyl-3-(4-(tert-pentyl)phenyl)propyl)morpholine; rel-(2R,6S)-4-[3-[4-(1,1-Dimethylpropyl)phenyl]-2-methylpropyl]-2,6-dimethylmorpholine; Loceryl

Amorolfine EP-Impurity-M-mixture of (1RS,2RS)-3-[(2RS,6SR)-2,6-dimethylmorpholin-4-yl]-2-methyl-1-[4-(2-methylbutan-2-yl)phenyl]propan-1-ol and (1RS,2SR)-3-[(2RS,6SR)-2,6-dimethylmorpholin-4-yl]-2-methyl-1-[4-(2-methylbutan-2-yl)phenyl]propan-1-ol; 3-(2,6-Dimethylmorpholino)-2-methyl-1-(4-(tert-pentyl)phenyl)propan-1-ol

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Purity:

Above - 95.0%

Technical Data:

We will provide complete documentation support for every Standard Material. All analytical reports such as ¹H NMR, ¹³C NMR, Mass, FT-IR, HPLC Purity/GC Purity/QNMR Purity, Water content by KF/ Loss on Drying/TGA (Thermo-gravimetric Analysis). Certificate of Analysis with potency report. Each Standard Material SER (Structure Elucidation Report) with NMR, Mass, IR spectral interpretation. This whole analytical document can be included in eCTD, ANDA, DMF submissions to regulatory agencies.

Amorolfine Chemical Reference Standard (CRS) is used in chromatographic analysis, such as HPLC, to accurately identify the characteristic peak of amorolfine in pharmaceutical formulations. It provides a reference for retention time and peak shape, ensuring correct peak identification, method reliability, and consistent quality control in accordance with pharmacopeial requirements.