Finished Product Testing, Quality Control and Quality Assurance

At National Custom Compounding (NCC), quality, accuracy, and patient safety are at the heart of everything we do. We understand that the effectiveness of compounded medicines depends on their stability, potency, and consistency. That’s why we have a rigorous Quality Assurance Program, which includes random stability and potency testing to ensure our products meet the highest industry standards.

Our Approach to Quality Testing

We conduct random sampling and laboratory testing on compounded medicines to verify both:

  • Stability: Ensuring the product maintains its integrity and effectiveness over its shelf life.
  • Potency: Confirming the compounded medicine contains the correct amount of active ingredients within acceptable variance limits.
  • Endotoxin: For sterile products, endotoxins are non-viable matter that may be present in the product. It is critically important that only a very-low (acceptable) level of these are present and therefore NCC tested finished products to verify safety.
  • Microbiological: This test involves the analysis of viable matter in finish compounded products and testing ensures that patient safety is not compromised.

These tests help us ensure our formulations and finished compounded products are both safe and effective for patient use.


Completed Test Examples

Below are a number of examples that National Custom Compounding has undertaken. If you would like to view other test results please contact our team via email.

Triest (80% Estriol, 10% Estradiol, 10% Estrone)

Results: Excellent accuracy within 8% of the target. The TGA allows up to 10% variance, confirming high precision in compounding.

🔍 View Result

Omeprazole Suspension (10mg/ml)

Results: Verified potency with 98% of the stated amount.

🔍 View Result

HCG (120 IU per Lozenge)

Results: Contained 101.2% of the stated amount, within NCC’s 5% error allowance and well within GMP (Good Manufacturing Practice) standards.

🔍 View Results

Melatonin Suspension (20mg/ml Liquid)

Results: Stability analysis at 30°C and 40°C showed only a 9% decrease in potency over 6 months, in Accelerated conditions (>40 degrees & 75% RH) confirming that the formulation and product is at least a 6-month shelf life.

🔍 View Results


Endotoxin & Microbiological Testing

To ensure the safety and sterility of our sterile preparations, NCC routinely conducts endotoxin and microbiological testing. These tests help confirm that our compounded products are free from harmful microbial contamination and meet the highest standards for sterility and patient safety.

Examples of Completed Microbiological Testing:

  • Sterile Injectable Solutions: Tested for bacterial endotoxins to ensure safety for intravenous use.
  • Ophthalmic Preparations: Subjected to sterility testing to prevent eye infections.
  • Intranasal Sprays: Evaluated for microbial contamination to confirm safe administration.

By maintaining strict sterility protocols and routine testing, NCC upholds the highest standards of compounding excellence and patient safety.

Atropine Eye Drops 0.025%

Results: A bacterial endotoxin level of <0.20 indicates that this product contains virtually no non-viable particles in the compounded product and safe. While the sterility report shows that after 60 days of testing, the sample contained no viable organisms (bacterial/fungal species). Both of these reports assure that the Atropine compounded product is safe for Patient usage

🔍 View Sterility Results 🔍 View Endotoxin Results

NAD+ Nicotinamide adenine dinucleotide 100mg/ml Sterile Solution

Results: For our NCC NAD+ sterile solution, the Endotoxin limit is set at <70.00 which is an acceptable level for a 70kg adult. The endotoxin report shows that the sterile compounding solution had a result below this level and is therefore safe for sterile usage. The sterility report indicates that there has been no growth of viable matter 14 days after the solution was compounded.

🔍 View Sterility Results 🔍 View Endotoxin Results


Supplier BUD (Beyond-Use Date) Testing

In addition to our in-house testing, we also reference stability testing conducted by manufacturers of the base ingredients we use. Leading suppliers such as Medisca and PCCA perform these tests to validate the stability of topical creams, oral suspensions, and transdermal formulations.

Supplier Stability Testing Reports

📄 Medisca BUD Data:

📄 PCCA BUD Data:


Commitment to Excellence

At National Custom Compounding, we are committed to continuous improvement and ensuring patient safety through rigorous quality control. If you would like more information about our Quality Assurance processes, please download our Quality Control Protocol below:

📥 Download NCC Quality Control Protocol

For any further inquiries, please contact us today via email.