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Deformulation of a Curcumin Nutraceutical By LCMS

Turmeric, the orange-yellow root of the Curcuma longa, has been used as a spice, medicine, and dye for at least 4,500 years. Turmeric consists of hundreds of compounds, but the curcuminoid curcumin is a major component of most commercial extracts. Although recent lab and animal research has found curcumin to contain anti-inflammatory and antioxidant capabilities, curcumin’s efficacy in human trials remains controversial, and trials have been limited due to its lack of oral bioavailability and rapid plasma clearance.  

Drug vs. Supplement 

Although the pharmaceutical industry has thus far viewed curcumin as a poor therapeutic agent, the nutraceutical industry does not have to prove efficacy to market curcumin for the treatment of disease. Because dietary supplements are not subject to the same FDA regulations as pharmaceuticals, there are currently no requirements that supplement labels be proven accurate or truthful. As a result, some marketed supplements contain less, or sometimes none, of the active ingredient they claim to contain.  

In a recent application note, Cambridge Polymer Group used liquid chromatography-mass spectrometry (LC-MS) to evaluate the curcuminoid content of a curcumin supplement relative to the claims made on the label. 

Product Deformulation  

Samples were obtained from a commercial supplement with a label indicating 180 mg of curcumin per capsule. Curcumin purchased from Sigma Aldrich was used as a control.  The percentage of curcumin in the control was consistent with the percentage reported by Sigma Aldrich's label.  

However, CPG found 40% less curcumin in the commercial curcumin supplement than advertised on its label. This deformulation shows that it is important for manufacturers to screen incoming raw materials for purity using validated testing techniques.  

Additionally, manufacturers can voluntarily submit products for certification by either the United States Pharmacopeia (USP) or National Science Foundation (NSF). A seal from either of these groups indicates that the consumer can trust that the product has been verified to contain the ingredients listed. As an ISO 17025 accredited and 9001 certified lab, CPG can test to USP standards and certify results. 

Read more. 

Dextran, a polysaccharide made from glucose, is widely used in the medical field for treatment of shock, as an antithrombotic agent, to reduce blood viscosity, and as an anticoagulant. The two most common forms are dextran 40 and dextran 70 (the 40 and 70 refer to their molecular weights, nominally 40,000 and 70,000 g/mol).

The USP monographs for dextran 40 and 70 describe a specific gel permeation chromatography approach that differs in success criteria from other GPC methods, and requires a unique GPC system setup and data analysis method. To qualify a dextran formulation under these USP guidelines, the material must be tested by this GPC method.

A calibration curve is constructed with dextrose and five dextran standards of known molecular weights, using either a Gauss-Newton method or the Nilsson-Nilsson method to determine the constants in the expression below for each of the standards based on their reported molecular weights M_i.

Mi = b₅ + exp(b₄ + b₁Ki + b₂K_i² + b₃K_i³)

Each of the standards must meet a rigorous accuracy check to ensure the GPC system is adequately set up to test the specific dextran samples and to ensure they meet the requirements of the USP monographs. Once the equipment is properly validated by this method, the samples can be tested.

CPG is experienced in this USP test method for dextran GPC analysis. Contact one of our scientists for more information.

A CPG twist on a holiday classic, with happier results

Total ion chromatogram of 4 chocolate samples showing peaks of caffeine and theobromine in water extraction.

ISO and ASTM are drafting a new standard on qualification of polymeric materials used for additive manufacturing using powder bed fusion (ISO/ASTM DIS 52925:2020). This standard is focused on polyamide 12 and 11, but the standard may be applicable to other polymeric materials.

The standard discusses the following test methods:

1. Particle size
2. Residual monomer
3. Relative humidity
4. Melt flow index
5. Molecular weight (either by GPC or dilute solution viscometry)
6. Melting and crystallization temperature by DSC

These tests are all performed by Cambridge Polymer Group, and can be used to qualify new material or requalify used material. Contact us for more information.

The ASTM workshop on Reprocessing Personal Protective Equipment (September 9-10, 2020, virtual workshop) is looking for presentations on the following topics:

• Methods/guides/practices to address reprocessing single use PPE and reusable PPE (including N95 respirators, personal face masks, protective clothing and coverings, etc.):

• Current issues with decontaminating single use PPE
• Cleaning
• Index matching
• Collection and distribution
• Loss of efficacy
• Degradation of components
• Tracking number of re-uses
• Cleaning/decontamination/sterilization
• New sterilization/disinfection methods – chlorine dioxide, etc.
• Assessing performance of the reprocessed device, including feedback from healthcare providers who have used reprocessed devices
• Effects of bioburden on re-use, for disinfection and perception
• Standards used
• Existing: ASTM, NIOSH and other
• Include limitations, such as multiple decontaminations
• Novel test methods introduced by researchers during the COVID-19 outbreak
• Methods/guides/practices for producing and or assessing performance of devices and device components that are in short supply
• e.g. masks, respirators, and face shields
• Both traditional device designs and novel designs using materials that are at hand
• Redesigning single use PPE for potential re-use during surges
• Discussion of FDA Emergency Use Authorizations (EUAs),
• For current EUAs, the impact on supply chain and on products/methods covered by current EUAs.
• Considerations needed to continue product access upon EUA expiration including impacts on the supply chain and on products/methods covered by current EUAs.
• Share perspectives on how existing standards helped you in addressing device shortages or how they could have been of more assistance

Abstract Submittal

To participate in the workshop, your 300-word abstract is due no later than July 26, 2020. Please see the ASTM symposium page for submission instructions.

Australian thorny devil 

Lizard Surface Energy Wetting

The Australian thorny devil (meloch horridus) is a desert-going lizard that has developed an impressive application of transport phenomenon to make the most of a limited source of water in the arid regions it inhabits.[1] The lizard has a skin surface that contains a continuous series of micro-channels that are capable of transporting water by capillary action towards the lizard’s mouth. As the lizard crawls over and under vegetation that contains droplets of dew, it effectively collects this water all over its body, allowing it to drink on the run. The lizard’s mouth, suitable for eating ants, is not adapted to drink water directly, necessitating this curious mode of drinking.

Capillary Transport in Nature

Capillary transport is quite common in nature. It is the mechanism by which water is moved from the roots of trees up to its leaves.  It is the means that our eyes drain tear fluid through the narrow tear ducts in our eyelids. This ability results from the attractive nature that water molecules have for each other, termed the forces of cohesion. This cohesion leads to surface tension, or the resistance of the surface of a liquid to an external force, such as a solid object penetrating the liquid. This tensile force causes the liquid to form a meniscus when placed in a narrow capillary, and if sufficient adhesion occurs between the water and the capillary wall, the water will be pulled along in the capillary, even overcoming the force of gravity if the capillary diameter is sufficiently small.

While this mode of drinking may appear convenient, one could argue that the quaffable benefits of the thorny devil's capillary-driven drinking mechanical are outstripped by the social liability of its crenulated dermis. But from a surface science point of view, the thorny devil has arrived at a low energy, high efficiency method of harvesting water.

For more information on surface energy measurements, contact Cambridge Polymer Group or visit our website.

 

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