Product Stability Testing

At National Custom Compounding, the Quality of our compounded medicines is an absolute priority. Quality is important to our customer’s health and so it’s important to us.

A part of our Quality Assurance Program involves random stability and potency testing of medicines. Random samples of the compounded medicine we make 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 and potency testing, looks at how accurately the product meets the criteria.

Examples of Completed Potency Tests

Triest

80 percent Estriol, 10 percent Estradiol, 10 percent Estrone  |  View 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 percent of the target. The TGA allows 10 percent variance for manufactured and compounded medicines.

Omeprazole Suspension

10mg/ml | View Results

HCG 120IU per Lozenge

| View Results

This test involved looking at the amount of Omeprazole & HCG in the products after they had been compounded in National Custom Compounding Lab’s. The test shows that NCC’s standard operating procedures (SOP) and the Technician’s skills are accurate as the products contain that required amounts. Omeprazole Suspension contained 98 percent of the stated amount while HCG lozenge contained 101.2 percent of the stated amount. This is within NCC’s 5 percent error allowance and well within the GMP (good manufacturing process’) which allows up to 10 percent error allowance.

Melatonin Suspension 

20mg per 1 ml liquid  |  View 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 percent in strength over 3 months. From this result we are confident that Melatonin Liquid/Drops are shelf stable for at least 6 months.

Supplier Bud Tests

Some of the base products that we use in our compounded products undergo stability testing by the manufacturer of the base. Two companies which undertake these tests are Medisca and PCCA. Below are attachments which show the testing that they have undertaken. We use this information, alongside our own stability data, to provide accurate Expiry dates on compounded products.

• – Medisca BUD data on TOPICAL BASES (ie creams) | View Results
• – Medisca BUD data on ORAL BASES (ie suspensions) | View Results
• – PCCA BUD on Testosterone Cream | View Results
• – PCCA BUD on Progesterone Cream | View Results
• – PCCA BUD on Methimazole Transdermal Cream (Vet) | View Results
• – PCCA BUD on Hydroquinone Cream | View Results
• – PCCA BUD on Omeprazole 5mg/ml Suspension | View Results

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