Ketotifen Fumarate EP Impurity D

Category

Ketotifen

CAS Number

88456-70-6

Molecular Formula

C19H19NO2S

Molecular Weight

325.4 g/mol

Synonym

4-[(aRaS)-1-methylpiperidin-4-ylidene]-4,9-dihydro-10H-benzo[4,5]cyclohepta[1,2-b]thiophen-10-one N-oxide;4,9-Dihydro-4-(1-methyl-1-oxido-4-piperidinylidene)-10H-benzo[4,5]cyclohepta[1,2-b]thiophen-10-one;

Keywords

Pharmaceutical Standards

Intermediates

Fine Chemicals

sulphur and selenium compounds

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 D is used as a reference standard in pharmaceutical quality control to identify and quantify this specific impurity in ketotifen fumarate drug substances and finished products. Its application supports method development, validation, and compliance with European Pharmacopoeia specifications to ensure drug safety and purity.

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