Testing and COA’s: What About That?
To begin with, there are a few good reasons why we test our products.
At first, we want to offer maximum safety for our researchers so it’s necessary to know what’s inside our products.
Secondly, we want to make sure our product is well dosed and perfect for research purposes.
And of course, we want to make sure our products are of the best purity we can achieve.
Identifying Chemicals and Compounds
There are a lot of methods to identify what chemical or compound is in a product. We can achieve this with basic tests like heating or freezing for simple compounds.
To clarify, when we look at our specific products we need proper tests for identification and analysis.
In particular, the most common tests for this range of products are spectroscopy and chromatography.
When we have identified our compounds in the product we can now check for how much of it is in our solutions. This can be done within the same test in case of some testing procedures.
For example, when we run a HPCL (High performance liquid chromatography) we are able to identify a compound. In addition, we know exactly how much of the compound is in this solution.
How do we know how potent and pure our product is?
Firstly, potency and purity go hand in hand most of the time but there is a big difference.
Potency is a measure of drug activity expressed in terms of the amount required to produce an effect of given intensity.
Purity is a measure of the amount of API (Active Pharmaceutical Ingredient) present in a sample compared to those of related substances, impurities, residual solvents, etc.
As a result, the more pure a product the greater the chance is that the product is very potent.
In short, in a pure product, there are fewer impurities. Therefore, the dosage of the main compound is higher.
Testing: What kinds of tests are available?
There are a lot of testing methods to test liquid chemicals.
The 2 main test methods are spectroscopy and chromatography.
What is the key difference between spectroscopy and chromatography?
Spectroscopy is the analysis of interaction among analyte and electromagnetic radiation.
Chromatography is the isolation of mixture into individual compounds with the help of the mobile phase and stationary phase.
In other words, we use spectroscopy is to identify and analyze the molecular structure of compounds.
Chromatography separates different compounds from each other to identify them.
What kinds of tests do we use at Rats Army and why?
At Rat’s Army we do multiple testing to confirm quality, purity and potency of all our products.
The 2 tests we use are the UV spectroscopy and HPLC tests.
UV spectroscopy is type of absorption spectroscopy in which light of ultra-violet region (200-400 nm) is absorbed by the molecule which results in the excitation of the electrons from the ground state to higher energy state.
Therefore, it excels in identifying chemical structures and in detection of impurities.
Ideal for liquid solutions
Very sensitive (to concentrations)
setup is difficult
Interference from outside light
Only suitable for identification and determination
High-performance liquid chromatography (HPLC) is a technique in analytical chemistry used to separate, identify, and quantify each component in a mixture. It relies on pumps to pass a pressurized liquid solvent containing the sample mixture through a column filled with a solid adsorbent material.
Each component in the sample interacts slightly differently with the adsorbent material, causing different flow rates for the different components and leading to the separation of the components as they flow out of the column.
Small sample size
Extremely good at separating compounds
Efficient and accurate
Only to be performed by experts
Can be time consuming
As a result, we need both testing methods to ensure the the quality of our products. As well as to make sure our customers know which product they get, how pure it is and how potent it is!
That’s why we use the HPLC-test with UV detector to make sure there is a complete image of the compound we sell and to guarantee optimal quality, purity and potency!
COA (Certificate of Analysis) is an important document provided with a range of manufactured products like for instance chemicals.
It reports on the quality assessment of the production lot. It ensures that the released product meets the desired quality standards.
Most of the biologics are produced in batches/lots. As a result, it becomes extremely important that every batch undergoes a quality assessment.
These quality assessments ensure that the purity, safety, and potency of the biologic drug is within its product specification range.
In other words, we test and obtain a COA to ensure that the compound has the desired purity, potency, safety, efficacy and other physiochemical attributes.
A good COA needs to be complete. Therefore, just a piece of paper stating what is in the compound and how potent it is is not enough.
Therefore, a good COA would need:
Identification of Kit Product /Product Name
Kit Part Number/Catalog Number
Kit Lot Number
Results (qualitative and/or quantitative)
Relevant document traceability references
In conclusion, a good COA is more then a few percentages on a piece of paper. It should show clearly which tests the lab uses, different samples they subject to the tests, objective facts and graphics…
You can see that yourself in the 2 examples given above.
We hope you now understand why we test so thoroughly and why we need a reliable partner for our tests.
In the end, we just want to ensure a top-quality product for all our researchers!