Stability studies are used to assess an Electronic Nicotine Delivery System’s (ENDS) performance and potential safety over time. Studies can be used to assess any possible degradation of ingredients such as nicotine or CBD, as it is important that the level of such ingredients does not lessen throughout the product’s shelf-life. This testing can also be used to determine if an accumulation of undesirables such as metals, degradation products or microbes are present. 

Stability studies for e-liquids and vape devices are usually carried out in real-time, with products being placed in a controlled environment for up to 12, 18 or 24 months (depending on the anticipated shelf life of the product). The usual conditions are 25℃ and 60% relative humidity. These conditions are set out in the ICH Q1 guidelines for stability testing. The products are tested at the start of the study and then at various time points during the study and results trended over time. Normal time points would include: 

For e-liquids, testing at each time point would include general properties such as appearance and pH, and active components such as nicotine content. 

For pod or disposable devices in which the e-liquid is sold contained within the device, testing can also include metals such as nickel and chromium, which may leach out of the components of the hardware and accumulate in the e-liquid over time. These would then possibly be transferred to the user in the aerosol and cause possible health implications, so it’s important that these are undetected throughout the study. 

Testing can also include water activity, which gives an indication of whether microbial growth would be viable in the product. 

In non-sterile products such as e-liquids, a microbial limit test is performed in order to assess the number of viable microorganisms present in the product. The presence of objectionable microorganisms in a product may be a potential hazard to the consumer. The microbial limit test is a series of tests that are carried out at the beginning and at the end of a stability study. 

Stability studies are an important part of proving a product’s integrity across its shelf life. It is important to ensure that a product behaves in its desired manner at both the beginning and end of its intended lifespan. Inter Scientific can offer both chemical and microbial testing to support e-liquid and vape product stability studies. Please contact info@inter-scientific.com for further information. 

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