Category
Clemastine
CAS Number
Clemastine STD -15686-51-8 ; Imp-B-1352549-49-5
Alternate CAS Number
14976-57-9 (Clemastine Fumarate)
Molecular Formula
Clemastine STD - C21H26ClNO; Imp-B -C21H26ClNO
Molecular Weight
Clemastine STD - 343.9 g/mol; Imp-B -343.9 g/mol
Synonym

Clemastine  : (+)-Clemastine; Meclastine; Pyrrolidine, 2-[2-[(1R)-1-(4-chlorophenyl)-1-phenylethoxy]ethyl]-1-methyl-, (2R)-; (2R)-2-[2-[(1R)-1-(4-Chlorophenyl)-1-phenylethoxy]ethyl]-1-methylpyrrolidine; 

Clemastine EP Impurity B : 4-[(1R)-1-(4-chlorophenyl)-1-phenylethoxy]-1-methylazepane ;

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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.

Clemastine for system suitability is a European Pharmacopoeia certified reference standard used in laboratory chromatographic tests to verify that an analytical system meets required performance criteria before sample analysis. This reference material helps ensure accuracy, precision, and compliance with compendial method conditions such as retention time and peak behavior in quality control procedures.