Cyproheptadine Impurities

Cyproheptadine is an antihistamine and serotonin antagonist used to relieve red, irritated, itchy, and watery eyes, sneezing, and a runny nose caused by allergies, irritants, and hay fever. It is also used to relieve itching from allergic skin conditions and hives, including hives triggered by cold temperatures or skin rubbing. Additionally, cyproheptadine has appetite-stimulating properties, making it useful for treating underweight conditions or cachexia.

Structure

Product Name

CAS No.

Cat No.

Action

Amitriptyline EP Impurity A

Amitriptyline EP Impurity A

Parent: Amitriptyline/ Nortriptyline/ Cyproheptadine

CAS No.: 1210-35-1

Cat No.: VL6350007

Cyproheptadine beta-N-Oxide

Parent: Cyproheptadine

CAS No.: 60251-34-5

Cat No.: VE0022918

Cyproheptadine EP Impurity A

Parent: Cyproheptadine

CAS No.: 256-81-5

Cat No.: VE006676

Cyproheptadine EP Impurity C

Parent: Cyproheptadine

CAS No.: 3967-32-6

Cat No.: VE009046

Cyproheptadine Impurity 1

Parent: Cyproheptadine

CAS No.: 54191-04-7

Cat No.: VE0013997

Cyproheptadine Impurity 2

Parent: Cyproheptadine

CAS No.: 54381-58-7

Cat No.: VE0014000

Cyproheptadine Impurity 4

Parent: Cyproheptadine

CAS No.: 54381-57-6

Cat No.: VE0014002

Cyproheptadine Impurity 5

Parent: Cyproheptadine

CAS No.: N/A

Cat No.: VE0014003

Cyproheptadine Impurity 7

Parent: Cyproheptadine

CAS No.: 19431-71-1

Cat No.: VE0014005

Cyproheptadine N-Oxide Impurity

Parent: Cyproheptadine

CAS No.: 100295-63-4

Cat No.: VL3110001

N-Nitroso Cyproheptadine Impurity

Parent: Cyproheptadine

CAS No.: N/A

Cat No.: VE0018057

Cyproheptadine Related Compound

Impurities in Cyproheptadine can arise due to chemical synthesis, degradation, or improper storage conditions. Regulatory agencies such as the FDA, EMA, and ICH enforce impurity limits to ensure drug safety and efficacy.

Types of Impurities in Cyproheptadine

Process-Related Impurities

Unreacted intermediates from chemical synthesis
Residual solvents (e.g., ethanol, methanol, dichloromethane)
By-products from manufacturing reactions

Degradation Impurities

Oxidation products due to exposure to oxygen or light
Hydrolysis impurities from moisture exposure
Thermal degradation products from high-temperature conditions

Elemental Impurities

Heavy metals from catalysts used in synthesis
Trace levels of arsenic, cadmium, lead, and mercury

Analytical Techniques for Impurity Detection

High-Performance Liquid Chromatography (HPLC)
Gas Chromatography (GC)
Mass Spectrometry (MS)
Fourier-Transform Infrared Spectroscopy (FT-IR)

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