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Quality Control Questions
Why do you test powders for identity and purity?
Simply put, without testing a compound it is impossible to be 100% sure that it is exactly what it says it is. While it's true that we have absolute confidence in our suppliers, it is important to us to verify every powder we use is of the correct identity and highest of purity. This is only possible through using appropriate techniques to test them.
To accurately identify our compounds, we send them to a third-party lab that uses a technique called FTIR. FTIR generates a complex spectrum report of peaks and valleys that makes it possible to analyze the compound and confirm its composition.When it comes to establishing the purity of our compounds, our third-party lab uses a technique called HPLC. Without this test, our compounds may have greater impurities that can affect your end result.
Doing these tests on our powders is part of why we have absolute confidence in the final product we provide our clients.
Why do you test your solutions for potency?
Thanks to the tests mentioned above, we already know that our powders are of the correct identity and high purity when they are sent for processing into solutions. The processing is done in our contract professional clean manufacturing facility by trained personnel who use the appropriate equipment to manufacture our solutions.
However, it is still important to test our solutions for potency. There is always a small risk of human error, as well as equipment or machinery malfunction. To verify that our solutions match our label criteria, our third-party lab performs an assay, using a technique called HPLC.
By testing for potency, we can be sure that our customers receive solutions that are not underdosed and that match our label criteria.
How is it possible that all your raw powder testing data has a chromotographic purity of over 99%?
When our suppliers successfully synthesize a compound, it will have a specific purity. However, it is possible to make a compound even more pure after synthesis by applying a technique called recrystallization. Recrystallization is a technique used to purify chemicals. Typically, suppliers will not do this unless you pay more or you are a very good business partner, because the yield of their synthesis will decrease. And that cuts into their profits.
Our suppliers know that we hold extremely high standards. When needed, they recrystallize batches for us so we can provide our clients with high purity compounds that have less impurities. To date, all our testing data, on all our raw compounds,shows a chromotographic purity of over 99%.
Where are your solutions made?
Our solutions are all made in a modern professional clean contract manufacturing facility.
Why do your concentration test reports show a result that may be marginally above or under your label criteria?
It's important to understand the difference between testing the concentration of a compound in our solutions and the testing of our raw powders. Our solutions are tested by our third-party lab by measuring the concentration of the active ingredient. This is what is referred to as an assay. In this assay test, a solution made of the unknown is compared to solutions made of pure, reference materials. The challenge with this is that there may be random errors in weighing, volumes, injections, peak integration, etc. As a result, the precision of a single measurement can be assumed to be +/-10%.
What do you mean with batch coding and why is this important?
Batch coding is an effective method through which we can track and trace our products. To make this possible, each solution is assigned a batch code, which is a unique series of numbers specific to that batch. In the event of a problem for example, we can use batch codes to see when the problem happened and what products were affected. Our customers can also see which test reports belong to their specific batch.
What do you mean by "our supply chain guarantees quality"?
Our raw powders are sent in for testing by our professional clean contract manufacturing facility. Similarly, our solutions are sent in for testing by our third-party logistics provider. Our third-party logistics provider also ships every single product to our customers. Everything we do is documented by our third parties. Each product that is shipped out, and each product that is manufactured. This way you can be absolutely sure that what has been tested is what you actually get.
