Product Information |
Product name |
Ciclopirox Olamine; Ciclopirox ethanolamine; HOE296 |
CAS No. |
41621-49-2 |
Molecular Formula |
C12H17NO2.C2H7NO |
Molecular Weight |
268.356 |
Quality Standard |
97.5% up by HPLC/ CEP/ USP |
Appearance |
White crystalline powder |
COA |
ANALYSIS |
SPECIFICATION |
RESULTS |
Appearance |
White crystalline powder |
Conforms |
Identification(IR) |
Similar to reference standard |
Conforms |
Ciclopirox Olamine content |
97.5% - 101.5% |
99.75% |
Ethanolamine content |
223-230mg/g |
225mg/g |
Residue on ignition |
≤ 0.1% |
0.05% |
Loss on drying |
≤ 1.5% |
0.35% |
Heavy metals |
≤ 10 ppm |
Conforms |
pH |
8.0-9.0 |
8.4 |
Related substances |
Impurity A<0.5% Total impurities<0.5% Single impurities<0.1% |
Conforms |
Solubility |
Soluble in alcohol and organic solvents such as dichloromethane and slightly in water |
Conforms |
Residual solvents |
dichloromethane<600ppm toluene<890ppm ethyl<5000ppm |
dichloromethane<250ppm toluene<280ppm ethyl<1200ppm |
Conclusion |
The sample complies with the Requirements of USP34. |
Usage |
Function of Ciclopirox Olamine
Ciclopirox Olamine, also known as Ciclopirox, exhibits the following functionalities:
1. Broad-spectrum Antifungal Activity: Ciclopirox is a synthetic antifungal agent with oral activity that inhibits a wide range of dermal fungi, yeasts, molds, and many pathogenic Gram-positive and Gram-negative bacteria. It effectively suppresses the growth of dermal fungi and yeasts at concentrations of 4-8 micrograms per milliliter. It is particularly suitable for the treatment of skin infections caused by dermatophytes, Candida species, and other fungi, such as hand癣, foot癣, onychomycosis, tinea corporis, and tinea cruris.
2. Anticancer and Anti-inflammatory Effects: Studies have shown that Ciclopirox also possesses anticancer and anti-inflammatory properties, inhibiting cell proliferation and inflammatory responses to a certain extent. However, further research and validation are required for the application of these properties in medical practice.
Advantages in China
1. Independent Research and Development: Ciclopirox is an antifungal drug developed by the Hubei Pharmaceutical Industry Research Institute in China, reflecting China's independent innovation capabilities in antifungal drug research and development.
2. Large-scale Production: With advancements in domestic pharmaceutical technology and cost control, China has the capacity to produce Ciclopirox on a large scale. This not only meets domestic market demand but also helps reduce drug prices, improving patient access to medication.
3. Quality Control: Chinese pharmaceutical companies strictly adhere to the quality standards and production process requirements set by the National Medical Products Administration (NMPA) during production, ensuring the quality and safety of drugs such as Ciclopirox.