Product Collomack is contains salicylic acid that dissolved in volatile solvents such as ethanol and acetone.
Each 1g of solution contains:
Salicylic Acid 0.1g( Acrtic Acid 99% , Docusate sodium, Castor oil, pyroxlin, ethanol 96%, acetone, isobuyl acetate)
Does the content of active substance during the stability storage will tend to rise?
It contains volatile solvents, does it safe to do accelerated stability studies at 40 degree celcius?
Thank you in advance
It is quite common to see the concentration of active ingredients in organic solvent preparations rise during storage. As you would imagine, the solvents evaporate leaving the samples behind to be more concentrated. Acetone with a boiling point of around 56 degree Celsius even worse than the like of ethanol/alcohols. You would not expect this in a sealed container but once opened, the loss through evaporation will be apparent. I would not put place acetone in a closed glass container at 40 degree Celsius knowing the margin of error in your incubator is even close to the boiling point. Have you tried looking into the stability of the product at a range of temperature - Say by refluxing it?
Do the stability study in flamed sealed glass ampules due to high content of volatile solvents.
Please look at the following below links which may help you in your analysis:
https://hal.archives-ouvertes.fr/hal-01637111/document
https://onlinelibrary.wiley.com/doi/pdf/10.1002/jps.2600510902
Thanks
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