Category
Epinastine
CAS Number
Epinastine STD-80012-43-7; 108929-04-0(HCl salt): IMP-A-706753-75-5; 141342-70-3(HCl - Salt)
Molecular Formula
Epinastine STD-C16H15N3: IMP-A-C16H13N3
Molecular Weight
Epinastine STD-249.32: IMP-A-247.29
Synonym

Epinastine STD-2,4-diazatetracyclo[12.4.0.02,6.07,12]octadeca-1(18),3,7,9,11,14,16-heptaen-3-amine; 9,13b-Dihydro-1H-dibenzo[c,f]imidazo[1,5-a]azepin-3-amine; (13bRS)-9,13b-Dihydro-1H-dibenzo[c,f]imidazo[1,5-a]azepin-3-amine; 1H-Dibenz[c,f]imidazo[1,5-a]azepin-3-amine, 9,13b-dihydro; (±)-Epinastine

Epinastine EP-Impurity-A-2,4-diazatetracyclo[12.4.0.02,6.07,12]octadeca-1(18),3,5,7,9,11,14,16-octaen-3-amine; Dehydro Epinastine; 9,13b-Dehydro Epinastine; 9H-Dibenzo[c,f]imidazo[1,5-a]azepin-3-amine

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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.

Epinastine is used as a reference standard in system suitability tests for chromatographic methods, such as HPLC, to ensure the analytical system is functioning correctly. It helps evaluate parameters like retention time, peak shape, resolution, and reproducibility, confirming that the method meets Current Regulatory Standards (CRS) before analyzing real samples. Its consistent and well-characterized behavior makes it a reliable compound for validating chromatographic system performance.