Random stability and potency testing – what’s involved?

At National Custom Compounding, the Quality of compounded medicines is an absolute priority because we understand that the medicines we create help improve patient’s health.

A part of our Quality Assurance program involves random stability and potency testing of all medications we produce. Our highly qualified laboratory team will make a medicine and then a random sample is sent to a testing laboratory.

We regularly run these tests to look at both medicine stability and medicine potency. By looking at stability, we test the expiry date of the medicine while potency testing looks for accuracy.

An example of a potency test is here (click to download results). This analysis looked at the combination of Oestrogen’s (E1, E2, E3) which make Triest. The result is excellent and shows that the product was made with great accuracy within 8 per cent of the target. The TGA allows 10 per cent variance for manufactured and compounded medicines.

An example of a stability test is here (click to download results). In this analysis we looked at our formula of Melatonin 20mg per ml liquid and analysed how stable it is at 30°c and 40°c. The result again shows that the formula is excellent, with a decrease of only 4 per cent in strength over 3 months. From this result we are confident that Melatonin Liquid/Drops are shelf stable for at least 6 months.

For more information relating to our NCC Quality Assurance process, please download our Quality Control Protocol, available here (click to download).

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