Mandatory: Analyzes for medical cannabis

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For the sale of cannabis flowers strict rules apply in Germany. After all, it is a medicine, in this case even one with anesthetic status. Accordingly, regulations such as those for the sale of finished medicinal products, often in the form of tablets, capsules or the like, must be adhered to. Only carefully checked products receive patients in the pharmacy. A guest contribution Tobias Wiezorek, Director of Quality Management, Quality Services International Chromatography.

The Federal Institute for Drugs and Medical Devices has published a minimum amount of analyzes required for cannabis flowers (to be found in the “German Pharmacopoeia” (DAB), last update on 08.04.2018). These and additional analyzes are required for each imported batch prior to sale and will be briefly presented below. In some cases, the analyzes performed on laymen may seem quite peculiar and pedantic, but this is characteristic of the pharmaceutical analysis at the highest quality level.

The sample delivered by the customer to the laboratory is first registered and recorded in the electronic laboratory data system. The first test point of the analytic is the determination of the identity. It will ensure that this product is cannabis. This is done using three different methods: First, the sample is considered in terms of its plant-typical appearance, followed by the microscopic examination of the ground sample and the identification of characteristic features, and finally the inclusion of a thin-layer chromatography, an extract of the sample. Briefly, here a fingerprint of the sample is taken by applying a drop of the extract to a special plate and then splitting this drop on the plate into its constituent parts (similar to, for example, a urine test strip). This fingerprint is compared with known reference substances (CBD and THC-A) and confirmed the presence of these two substances. This method is actually obsolete by the later analysis of the complete cannabinoid spectrum in the laboratory, but serves the comparatively simple identification of the product in pharmacies. Here, once the goods have been received, the identity has to be checked once more, and it is therefore necessary to codify this method in the pharmacopoeia as well.

“Foreign components”?

In the next step, the purity of the product is tested. For this purpose, first the unmilled sample is optically tested for the presence of possible “foreign components”. The limit here is two percent – but so far no cannabis-foreign products have been detected in the samples studied. All further analyzes are then carried out with the ground sample – but this is not the usual mills for herbal medicines, since the resinous properties of cannabis either glued the mill or lost the trichomes during the milling process and so can take place a change in the ingredients. The cannabis is crushed instead with a grinder.

A portion of the crushed sample is weighed exactly and stored for 24 hours at low pressure and 40 degrees Celsius in a special oven and then weighed exactly. The difference between the masses is used to calculate the moisture content in the product (maximum of ten percent). The most critical test is certainly the cannabinoid profile. For this, the sample is completely extracted with pure ethanol (“alcohol”) and 0.005 ml of this extract injected into a high pressure liquid chromatography (HPLC) system.

In this device, a physical-chemical separation process by the substance mixtures or the various ingredients are separated in the sample. Thus, exactly the content of the individual substances can be determined. Depending on the chemical structure and its specific properties, the cannabinoids can be separated from each other and individually calculated in terms of their content. Because of the high chemical similarity of the properties of the cannabinoids, such as between d8-THC and d9-THC, separation is a complex process that requires expertise and experience.

Strictly regulated tolerance limit

The key question is: Does the content of the active ingredient on the packaging match that in the sample (tolerance: +/- ten percent)? This tolerance limit is regulated relatively strictly by the pharmacopoeia. In the case of herbal medicinal products, variations in the active substance content already occur as a result of different illumination of the plant. In the case of synthetic drugs, on the other hand, the active substance content is constant, since such external influencing factors do not influence the content.

The cultivation of cannabis plants and the subsequent processing process gives rise to a multitude of potential sources of contamination. The moist, warm growing conditions provide an ideal breeding ground for microorganisms. In order to detect microorganisms, they are released from the sample in a sterile procedure and grown on special nutrient media. After about one week, the growth of microorganisms is optically visible.

The limits of the pharmacopoeia allow in a certain scope a growth of non-pathogenic microorganisms. However, this is very low, so that the microbiological examination must be carried out under almost “clinical” conditions.

The moist, warm growing conditions also favor the potential growth of molds that release (Afla) toxins. These substances are regulated due to a carcinogenic effect, in the pharmacopoeia with a limit value and may be contained only in the ultra trace range (<4 μg / kg). The analysis is carried out here by means of LC-MS / MS – a super-sensitive analysis system, which is also used for example for the analysis of doping samples.

Detect heavy metals

Finally, the analysis of impurities by human influences. Thus, toxic heavy metals such as lead, cadmium, arsenic, mercury are routinely detected by “ICP-MS”. In order to avoid plant diseases, insect and mold infestation, the use of pesticides is also conceivable, which are detected in a highly complex pesticide screening. This is based on the minimum requirement of the pharmacopoeia. In addition, testing is also carried out for those pesticides that are known to be available and that could have been used.

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On special customer request further parameters such as the terpene profile of the sample can be analyzed, whereby no requirements are defined by the German Pharmacopoeia. The testing laboratory requires full methodological competence in the areas described, an investment in corresponding test equipment and reference substances, an extensive approval by the Federal Opium Agency and proof of competence as a drug testing laboratory.

In light of the fact that cannabis is a medicine prescribed in part to already immunocompromised patients and whose ingredients are inhaled, the relevance of ensuring the quality of the medicinal product is particularly clear.

Only accurate analysis can protect the consumer from potentially harmful contaminants.

Continue at:  https://krautinvest.de/pflicht-analysen-fuer-medizinisches-cannabis/

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