Function
This product is a white or cream-like cream of emulsion type. Each gram of Aloesone cream contains 0.1% mometasone furoate. Other inactive ingredients are white petrolatum, white wax, propylene glycol ethylene glycol stearate, titanium dioxide, water and phosphoric acid solution.
Pharmacology and Toxicology This product is a synthetic glucocorticoid, which has anti-inflammatory and anti-allergic effects. It is characterized by an increase in the strength of action and a disproportionate increase in side effects, and it is only used once a day.
[Indications] Skin inflammations and pruritus caused by skin diseases that are effective in corticosteroid treatment, such as neurodermatitis, eczema, atopic dermatitis, seborrheic dermatitis, and psoriasis.
COA
Items | Standard | Results | |||||
Description | White to off-white powder | Off-white powder | |||||
Solubility | Soluble in acetone and in methylene chloride. | complies | |||||
Identification | A: Infrared Absorption | complies | |||||
B:HPLC | complies | ||||||
Melting point | About 220℃ | 221.5~222.5℃ | |||||
Specific rotation | +56.0°~+62.0° | +60.1° | |||||
Loss on drying | max.0.5% | 0.27% | |||||
Water | max.0.5% | 0.24% | |||||
Residue on ignition | max.0.1% | 0.03% | |||||
Heavy metals | max.30ppm | complies | |||||
Chromatographic purity (TLC) | |||||||
-single impurity | max. 1.0% | complies | |||||
- total impurities | max. 2.0% | complies | |||||
Assay (HPLC, based on drying) | 97.0%~102.0% | 99.5% | |||||
Residual Solvent | |||||||
Methanol | not more than 3000ppm | complies | |||||
Ethyl acetate | not more than 5000ppm | complies | |||||
Acetone | not more than 5000ppm | complies | |||||
Pyridine | not more than 200ppm | complies | |||||
Methylene chloride | not more than 600ppm | complies | |||||
Chloroform | not more than 60ppm | complies | |||||
Particle size | 90%≤10um 100%≤20um | complies | |||||
Conclusion: The product complies with the requirements of USP39 Standard. | |||||||
Analyst | panyong | Checker | panwang | Approved by | yangmingcheng |