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Stability Studies: Protect your customers and your business.

Just like the food in your fridge; your skin care, cannabis and drugs expire. Expiry dates tell the distributors and consumers how long they can safely keep and use your product before the product becomes ineffective, potentially harmful or just goes bad.

So how is this date determined? Stability studies. Stability studies don’t only tell you how long your product is good for, but also in what way it changes past the expiration date. Factors like temperature, humidity or light may affect the stability of your product or your package integrity.

Stability studies work by simulating the specific environmental conditions that will place your product under stress. Keystone’s state-of-the-art stability chambers can control the specific temperature and humidity that your product is exposed to. This determines the rate at which your product or packaging degrades. This may take place over the course of one or two years during which, your product will be observed and the active ingredients will be analyzed for efficacy compared to the baseline value. The study is terminated when the active ingredient falls out of specification. From this information, you can determine your products shelf-life and optimal storage conditions, which will ultimately ensure safety for the consumer.

1-2 years might seem like an awfully long time, but regulatory boards like Health Canada do allow for accelerated stability studies to be conducted. These studies place the product under harsher conditions (ie. 40 °C and 75% RH), then a timeline up to 2 years can be extrapolated from the results. During this time, a Real-Time study (i.e. 25 C + 65%RH) is run in parallel for two years to confirm the accelerated data.

Although stability is not yet required for cannabis or cosmetic products, it will help you avoid potential issues with your product that would affect your companies’ sales and reputation. Aside from losing the desired texture or colour, expired makeup and skincare products can cause acne, skin irritation or even infections. This reflects especially poorly on your company if you’re marketing a skincare product that is meant to prevent skin problems.

Expired cannabis on the other hand is less likely to cause health problems, but will lose efficacy and potency. Having a specified expiration date is a good way to cover your bases in case a customer comes in complaining about a 3-year-old product not working as intended. Keep in mind too that dried cannabis is a plant product and while it is unlikely to mould, it still may, depending on storage conditions.

Let’s get the ball rolling on your stability study! Here’s what you have to do to get started:

  • Read the Health Canada Stability guidelines and the World Health Organization guidelines documents to have a full understanding of your stability study requirements. If you are planning to submit the data to a regulatory board like Health Canada, the stability study will need to be conducted on 3 separate production batches.

  • Contact Keystone. Get in touch with us so we can discuss your specific stability needs and help you plan your stability protocol.

  • Prepare your stability study protocol. This will include:

    • required environmental conditions

    • length of the stability studies

    • sample time pulls

    • testing required to analyze the active ingredient or other destructive specifications.

Running a stability study on your product will ensure that you are supplying your customers with the best possible product while protecting them, and yourself, from unintended side effects. Give Keystone Labs a call or send us an email if you need any more information. Keystone would be happy to help you with every step of the stability study process.

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