Medicinal Cannabis Production

One of the most significant standards introduced by the United States Pharmacopeia (USP) has been a new methodology for determining elemental impurities and contaminants in drug products and diety supplements. These new methods have been going through a review and approval process for several years, and, a recent announcement by the USP has indicated that these new chapters will be implemented on January 1, 2018.

The new methods will address the limitations of the current methods, extending the list of analytes, reducing the maximum permitted exposure limits and taking into account the route of exposure. The use of close vessel sample digestion and modern instrumental techniques is also introduced to ensure the accurate recovery and determination of individual analyte concentrations.

Chapter and ICH Q3D Chapter and ICH Q3D specify maximum limits for elemental impurities permitted in drug products, drug substances, active ingredients, and excipients.

Medicinal cannabis manufacturers should be concerned about the content of all heavy metals in their final product because all cannabis is grown for ingestion of some form. However, a few that stand out because they're so dangerous are arsenic, cadmium, cobalt, copper, lead, and mercury. Heavy metals, depending on their concentration, can have a wide range of effects on the human body. Everything from headaches, nausea, to organ failure, and cancer in cases of prolonged or extreme exposure. Because cannabis is often combusted, there are increased respiratory risks as well.

If any cannabis product that contains heavy metals is ingested, the heavy metals mimic other essential elements and hence is replaced in the consumers' bones and other cellular structures. In short, these metals bind with sites which were not originally intended for them and, in the process, they remove the original metals from their natural binding sites. This is what causes the malfunction of cells and, ultimately, toxicity. Heavy metals also cause oxidative stress, which greatly increases free radicals in the body, causing further damage.

Medicinal cannabis manufacturers, therefore, need the ability to test for heavy metals because medical marijuana patients are using marijuana to improve their health, not make it worse. Medical marijuana patients often have compromised the immune system, which can make them especially susceptible to harm from heavy metals.

Analytik Jena provides complete solutions from sample preparation to final analysis in their TOPwave microwave digestion system and the Plasma spectrometers; PQ9000 and PQMS.