At National Custom Compounding, the Quality of our compounded medicines is an absolute priority because we understand that the medicines we create assist in improving patient’s health.
A part of our Quality Assurance program involves random stability and potency testing of medicines . The Lab 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 and potency testing, looks at how accurately the product
Completed Potency Tests
- Triest – 80% Estriol, 10% Estradiol, 10% 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% of the target. The TGA allows 10% 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 Technicians skills are accurate because the products contain that required amounts. Omeprazole Suspension contained 98% of the stated amount while HCG lozenge contained 101.2% of the stated amount. This is within NCC’s 5% error allowance and well within the GMP (good manufacturing process’) which allows upto 10% error allowance.
Completed Stability Tests
- 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% 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 which we using in our compounding products under goes stability testing by the manufacturer of the base. Two companies which undertake these are Medisca and PCCA. Below are attachments which show the testing that they have undertaken and we use this information, along side 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)