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Testing for AUTHENTICITY

Testing for AUTHENTICITY, POTENCY, PURITY, and SAFETY

The CompliMed® lab is located in a university setting to maintain a vital link between applied science and academia and to be in the forefront of evolving research and testing methods. Many companies rely solely on a Certificate of Analysis (C. of A.) from the supplier to tell them the authenticity, potency, purity, and safety of their raw materials. We review C. of A.'s, but we place our primary emphasis on performing our own tests on raw materials to verify the accuracy of these documents and the purity and potency of the products. Between 500 and 650 samples are tested in our own laboratory each week. Despite sourcing from high quality raw material suppliers who each guarantee the quality of their materials, some shipments are rejected and returned to the supplier following testing at our lab.

Step 1: Authenticity: 
All materials are tested for identity. CompliMed® employs a variety of analytical techniques including: Thin Layer Chromatography (TLC), Ultra-Performance Liquid Chromatography (UPLC), High-Performance Liquid Chromatography (HPLC), Gas Chromatography (GC), Inductively-Coupled Plasma-Optical Emissions Spectrometer (ICP-OES), Near Infrared (NIR), Fourier-Transform Infrared (FTIR), Ultraviolet-Visible Spectrophotometer (UV-VIS), Titration, Enzymology, Wet Chemistry, and other methodologies where appropriate.

Step 2: Potency: 
Vitamins and herbal extracts are tested for potency by Ultra Performance Liquid Chromatography (UPLC), High- Performance Liquid Chromatography (HPLC), and Gas Chromatography (GC). Detection capabilities for these instruments include MS (mass spectrophotometer), ELSD (evaporative light scattering detection), PDA (photo diode array), SFD (scanning fluorescence detection), and FID (flame ionization detection). These cutting-edge instruments allow for the selective identification and quantification of marker ingredients in both raw materials and finished products. Other high-end instruments used for identification/quantification of active ingredients include: Inductively Coupled Plasma Mass Spectrometry (ICP-MS), ICP-OES, UV-VIS, FTIR, and NIR.

Step 3: Purity and Safety: 
Several tests must be conducted to insure a raw material's purity and safety:

Microbial – Raw material samples are tested at our microbial laboratory for pathogens – the overgrowth of bacteria, yeasts and molds.

Irradiation – CompliMed® does not use irradiated herbs. A supplier must certify that an incoming herb has not been irradiated. We have the capability to screen incoming herbs for irradiation using a Pulsed PSL system (photo stimulated luminescence).

Pesticides/Herbicides – Gas Chromatography Mass Spectrometer (GC-MS) equipment screens for over 500 pesticides and pesticide residues.

Heavy Metals – Raw materials are tested for heavy metals such as lead, arsenic, mercury, and cesium with the Inductively Coupled Plasma Mass Spectrometer (ICP-MS).

Next Steps:
After a raw material's laboratory results are accepted by our QC group, the material is released from quarantine and is used to formulate and manufacture products for CompliMed® in our own facility according to good manufacturing practices (GMPs), strict manufacturing operating procedures, routine checks and point-to-point inspections.

Testing Throughout Production and the Finished Product - We continue our dedication to quality by testing the finished products for CONFIRMATION, DISINTEGRATION and STABILITY.
Confirmation – CompliMed® statistically samples finished bulk pills and performs lab testing to ensure our processes result in products that meet label claim.

Disintegration – Our tablets and capsules are tested to see how fast they dissolve according to USP (United States Pharmacopeia) guidelines. In general, tablets must disintegrate within 30 minutes or less, capsules within 45 minutes or less. Enteric-coated products are tested to ensure they survive an acidic (stomach) environment, and are then tested to ensure they break down in a basic (intestinal) environment.

Stability – Most of our products are shelf-stable for a minimum of one to three years. Products are routinely pulled from production to be entered into a real-time stability program, where they are monitored and tested over the shelf life of the product. Additionally, products may undergo accelerated stability testing following ICH (International Conference on Harmonisation) guidelines. We stamp a use-by date on each label so you can be assured of a fresh product.