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February 1, 2017

Quality Control Lab and Testing

In order to deliver quality products to our customers, raw materials and finished products must undergo a vigorous quality control process. Our newly renovated Quality Control Lab is not only beautifully crafted but fully equipped to handle this task.

All raw materials that are to be used in production must first go through testing to certify its identity and quality. During the production process, in-process checks are also performed to assess that a consistent and quality product is being produced. Finally, each finished product is then tested to ensure that each product is safe and meets regulatory requirements. We set extremely high standards during our quality control lab and testing procedures to ensure the best possible results.

In-House Raw Material Testing, Finished Product Testing & Stability Testing

It is our belief that in order to get quality products quickly, our quality control lab and testing procedures should be able to process materials in an efficient and thorough manner. Therefore, we run almost all of our raw material, finished product and stability testing in-house using fully validated methods on qualified and certified equipment, using trained chemists and biologists.

Our lab processes and assesses each raw material, finished product, and stability product that comes through our doors and is produced at our facility. In order to perform this daunting task, we need the highest quality personnel and equipment.

Quality Control Lab and Testing Equipment

Chromatography – United States Pharmacopeia depicts chromatography as a procedure where complex mixtures can be separated and quantified using their specific properties. This is a powerful tool in assessing identity, purity, and strength from pure raw materials to complex finished products.

– HPLC/Mass Spectroscopy or High-performance liquid chromatography is one of the best ways to quantify an analyte. All methods used at ion are fully validated to assess precision, accuracy, and linearity to ensure that analytes tested can be accurately quantified in our products. Furthermore, when applicable, we only use USP traceable standards to give us the highest precision possible when quantifying even micronutrients. Our lab also possesses cooled autosampler technology allowing us to refrigerate samples while testing, slowing the sample degradation process for unstable analytes. Finally, we have a single quadrupole mass spectrometer, which we have used in our more complex validations.

-TLC or thin layer chromatography is based on similar science as HPLC. This technique is a powerful tool in identifying actives in complex botanical mixtures. All of our standards are high quality fully characterized materials from highly reputable vendors like ChromaDex.

-AA or atomic absorption is used to identify and quantify minerals and metals in raw material and finished products. Using fully validated methods for each mineral and metal tested, we can assure minerals added meet label requirements and confirm that raw materials and finished products are within safe limits for heavy metals.

-Microbiology. Ion has a fully equipped micro station, which includes: incubators, isolated pipets, autoclave, and HEPA-filter micro hood. This allows us to accurately assess the quality of our products using USP methods that have been verified in-house. We routinely test for Salmonella, E. coli, S. aureus, standard and virulent yeast and molds, Pseudomonas strains, and total aerobic counts.

– UV Spectroscopy is used at Ion Labs to identify and quantify the proteins used in our products. Using a fully validated procedure and traceable standards, all required raw materials and finished products are run using a modified protein Lowry procedure.

To constantly provide customers with the best quality, we are constantly working to adhere to the standards set forth by the FDA, NSF, USDA and other highly reputable governing bodies. We are constantly improving and enlarging our technologies, methods, and personnel to make sure we have the best in the industry.

Below is an example of an Ion Labs Certificate of Analysis:

Certificate of Analysis Example Document

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Ion Labs,Inc. has been a contract
manufacturer since 1983 for
Global Distributors, National Retail
Chains, Pharmaceutical
Companies, Wholesale Product
Distributors, and numerous
successful start-up nutritional
supplement companies.
Ion Labs Headquarters is a
150,000 sq. ft. facility in Largo FL.

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