If you are building a lasting business based on honesty and integrity then we are the kind of company you can appreciate. A fully equipped laboratory and a robust cGMP compliance system ensures that our brands are selling.
We don’t take any shortcuts when it comes to Quality Control. Frankly, this is what every single Contract Manufacturer will tell you! Here’s exactly what we do:
Inductively coupled plasma-mass spectrometer (ICP-MS) is an instrument we use in our in-house laboratory in order to quantify the concentration of metallic elements such as:
Upon customer request and according to availability of standards, we can also perform quantification of many other elemental contaminants such as Nickel (Ni), Copper (Cu), Chromium (Cr), Cobalt (Co), Molybdenum (Mo), Osmium (Os), Iridium (Ir), Rhodium (Rh), and more.
Many contract manufacturers’ single point of focus in their lab is a microbiology plate reader from 3M (with petri film). This instrument is completely unsatisfactory for use on herbs. We have the 3M system and we know it does not work reliably on measuring microbiology in herbs and extracts. It does not work for two reasons:
(1) antimicrobial metabolites or chemicals in the samples require the chemists to dilute the sample to a level that makes the results unreliable; (2) the color of the samples get in the way of reading the plates, i.e. turmeric. We primarily use the 3M system for analyzing chemicals for microbiology contamination.
Testing herbs for identity is essential. The most appropriate method per USP is the high performance thin layer chromatography (HPTLC). Even if DNA testing has a fancy appeal, it unfortunately does not work when it comes to identifying herbal supplements. The following statement from USP (US Pharmacopeial Convention) urges people to not rely on DNA testing, stating, “DNA-based methods are not suitable for materials, such as botanical extracts, that were subjected to processes that denature, degrade and destroy DNA.”
PureNSM checks every herbal batch with an HPTLC onsite. HPTLC is the premium test equipment for identity tests.
If formulation, inventory and production records are kept in Excel spreadsheets it can cause disorganization, confusion, mistakes and makes it easier for the employees of the manufacturer to cut corners without leaving a trace.
WARNING: Avoid “Drylabbing”
The only remedy for ensuring that the lab you hire isn’t “DryLabbing” is to send a known sample. We recommend you do so randomly. Dry labbing is when a lab claims to do research, but in reality just guessed the conclusion. In other words, they are cheating! Make sure your contract manufacturer is not drylabbingyou! For more on how to avoid drylabbing.
We just installed our high-performance liquid chromatography (HPLC) equipment. This will give us a quicker turnaround for less cost. The HPLC is the most effective instrument in determining the identity and quantity of elements and molecules in herbal supplements. We will continue to outsource this test until our in-house chemists have completed training on the HPLC.
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