Why Choose Us Over the Other Guys?
Since our inception in 1993 our primary goal has been to manufacture pure products. Our supplements are 100% pure – no flow agents, no fillers, no artificial colors, no binders, no excipients – which means your supplement is safer, more potent and more absorbable. Click here for more on this subject.
We don’t have minimums, order as little as you want. Prices get competitive at as little as 75,000 capsules. Compare that to other guys who force you to buy 250,000 capsules or more on your FIRST ORDER!
The materials we buy are better quality. Many of the large raw material suppliers in the USA often send “spent” herbs to contract manufacturers. Those are what is left over from the extraction process. See more on this below.
PureNSM is FDA registered by Registrar Corp.PureNSM is now working on obtaining Non-GMO registration.
We’re making your product, not ours. It’s only right that you are as involved as you want to be in every phase of production for your supplement. Call us, email us, or instant message us. There will always be someone here to personally review the status of your product and answer any questions you might have. Your product is important to you and therefore it’s important to us.
Quality Control is Our Number One Priority
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:
• Heavy Metal Analysis (ICP-MS)
• Microbiology Analysis (Biolumix and 3M)
• Identity Testing (HPTLC and FTIR and DNA Testing)
• Potency Testing (HPLC)
• Systemized Operations (GMP process on ERP)
Our raw material supplier know we test! Why? Because we always send back any substandard product they try to sell us. Yes, even the largest and most prestigious nutraceutical raw material suppliers in the US have, on occasion, sent us substandard goods. However, once we call them out on their sup-par product, they exclusively send us “top shelf” raw materials.
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:
The above heavy metals are the most frequent contaminants in food and food supplements. Lead is definitely the leader in contamination (90%). You are ill advised to manufacture with a company that does not actually test YOUR product, protecting your customers from potential harm and you from potential lawsuits involving California Proposition 65 (yes, even non-California companies have to comply, in case products can find their way to California).
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.
This is why we rely on the Biolumix system, the premium testing method in the industry. Based on GMPs and customer requests, we test for the following:
- TOTAL AEROBICAL COUNT
- TOTAL YEAST AND MOLD COUNT
- TOTAL COLIFORMS
- ENTEROBACTERIACEAE FAMILY
- E. COLI
- STAPHILOCOCUS AUREUS
- PSEUDOMONAS AURIGINOSA
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. See this blogpost. 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.
Why is testing with HPTLC so important?
Take a look at the two images below:
Image-1 on the top is the chromatogram of UvaUrsi leaf powder compared to Image-2 on bottom, a botanical material and chemical reference standard. We observed that the UvaUrsi leaf powder looked very faint and was missing some of the components that are observed in the botanical reference material. Based on this, the PureNSM lab highly suspected that the raw material had been previously extracted and the vendor only sent us “leftovers”. Based on this, we rejected the material. Which one do you want? If you want the more potent one, then have your products manufactured with us!
Oskar Thorvaldsson next to the HPTLC equipment from Camag.
Regulations: FDA, FTC and CA Proposition 65
We have extensive regulatory insights, which our customers benefit from. As a customer you receive free label reviews from the perspective of both FDA regulations and California Proposition 65. This includes structure and function claims, nutritional facts, and daily amounts permitted according to regulations based on our in-house laboratory analysis. One area of experience is our insight into California Proposition 65.
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.
PureNSM operates on an ERP system from Batch Master thatis tailored to and complies with the FDA’s 21 CFR Part 11 and cGMP standards, including electronic signatures and audit trails.
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, click here.
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.
We are in the process of purchasing our first GC-MS, or gas chromatography–flame Ionization detector/mass spectrometer.
The GC-MS is used to analyze volatile molecules with a high melting point, such as fatty acids in fish oil and pesticides. We will continue to outsource this test until our in-house chemists have completed training on the GC-MS.