Category
Ketotifen
CAS Number
126939-27-3
Molecular Formula
C19H21NO2S
Molecular Weight
327.44 g/mol
Synonym

(4RS)-4-Hydroxy-4-(1-methylpiperidin-4-yl)-4,9-dihydro-10H-benzo[4,5]cyclohepta[1,2-b]thiophen-10-one;

Keywords
Aromatics
Heterocycles
Impurities
Pharmaceutical Standards
Intermediates
Fine Chemicals
sulphur and selenium compounds
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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.

Ketotifen Fumarate EP Impurity C is used as a reference standard for the identification and quantification of related impurities in ketotifen fumarate drug substances and finished products. It plays a key role in method development, validation, and routine quality control in accordance with European Pharmacopoeia specifications.