Laboratory

Criteria for cannabis for medicinal use

• Macroscopic description - visual description

• Foreign impurities - according to Ph. Eur. 2.8.2

• TLC - thin layer chromatography according to Ph. Eur. 2.2.27

• Loss on drying - according to Ph. Eur. 2.2.32

• Total ash - according to Ph. Eur. 2.4.16

Criteria for cannabis for medicinal use

• Pesticide residues - corresponding to the limits of Ph. eur. 2.8.13

• Heavy metals - Pb, Cd, Hg - according to Ph. eur. 2.4.27

• Aflatoxins: Aflatoxin B1, total aflatoxins B1, B2, G1 and G2 - according to Ph. Eur. 2.8.18

• Ochratoxin A - dle Ph. Eur. 2.8.18

• Degradation products -cannabinol (CBN) according to Ph. Eur. 2.2.29

• THC (d-9-tetrahydrocannabinol) to Ph. Eur. 2.2.29

• CBD (cannabidiol) to Ph. Eur. 2.2.2

In case of interest, we also offer the measurement of other cannabinoids according to Ph. Eur. 2.2.29

• CBC (cannabichromen)

• CBG (cannabigerol)

• THCV (tetrahydrocannabivarin)

• D-8-THC (d-8-tetrahydrocannabinol)

• D-10-THC (d-10-tetrahydrocannabinol)

• HHC (hexahydrocannabinol)

The list of individual cannabinoids that we are able to analyze is continuously expanding based on the demand of our customers

• Terpene profile - according to a validated method, we measure and compile a terpene profile of the 23 most important constituents.

Criteria for cannabis for medicinal use

• TAMC - total aerobic microorganism count according to Ph. Eur. 2.6.12

• TYMC - total number of yeasts and moulds according to Ph. Eur. 2.6.13

In addition to the required specification, we offer microbiological analyses

• Bile-tolerant G-bacteria according to Ph. Eur. 2.6.13

• Escherichia coli according to Ph. Eur 2.6.13

• Salmonella according to Ph. Eur. 2.6.13

• Accelerated stability tests of medicinal substances or preparations shall be carried out at a temperature at least 15°C higher than the normal, maximum permissible (required) storage temperature in the Good Distribution Practice regime.

• In this type of testing, when the medicinal substance or preparation is stored in primary packaging, the primary packaging is subjected to stress storage conditions in a thermostable chamber, under conditions of 40°C ± 2, at a relative humidity of 75% ± 5, for a period of 6 months.

• The stability test shall monitor all parameters of the medicinal substance or preparation which may change during storage and which could affect the quality, safety and/or efficacy. The stability test evaluates the physical, chemical, biological and microbiological properties of the medicinal substance.

• Control measurements shall be performed using validated and stability indicating control methods under GMP regime, within the framework of the GMP Certificate for Control Laboratory Activities held by the Contractor.

• SSZs of medicinal substances or preparations are carried out at the normal temperature (required) for storage under the Good Distribution Practice regime

• In this type of testing, when the medicinal substance or preparation is stored sealed in primary packaging, the primary packaging is subjected to storage in a thermostable box, under conditions of 25°C ± 2, at a relative humidity of 60% ± 5, for a period of 12 months.

• The stability test shall monitor all parameters of the medicinal substance or preparation which may change during storage and which could affect quality, safety and/or efficacy. The stability test evaluates the physical, chemical, biological and microbiological properties of the medicinal substance.

• Control measurements shall be performed using validated and stability indicating control methods under GMP regime, within the framework of the GMP Certificate for Control Laboratory Activities held by the Contractor.