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Analysis of Medicinal Cannabis

Since March 2017, general practitioners and specialists in Germany have been allowed to prescribe medical cannabis in various forms, such as flowers or extracts, for serious illnesses. Due to THC contents above 0.2 %, these products are subject to the German Narcotics Law (BtMG). The handling of these products therefore requires a BtM permit from the Federal Institute for Drugs and Medical Devices (BfArM). QSI is in possession of this permit and is therefore able to carry out analyses of cannabis/preparations.

In addition to the many analyses of the DAB and Ph.Eur. this includes in particular the determination of cannabinoid content as well as the testing for impurities (pesticide residues, mycotoxins, heavy metals, microbiology, etc.).

QSI holds a manufacturing permit according to § 13 AMG. The Qualified Person of QSI monitors the processes and can take over the batch release within the scope of the manufacturing permit.

Analytical Services

Analyses according to DAB monograph “Cannabis flos”:

  • Identity
    • A: macroscopic
    • B: microscopic
    • C: Thin-layer chromatography(2.2.27)
  • Purity
    • Foreign matter (2.8.2)
    • Loss on drying (2.2.32)
    • Cannabinol (HPLC)
  • Content by HPLC
    (
    Δ9-Tetrahydrocannabinol, Δ9Tetrahydrocannabinolic acid, Cannabidiol and Cannabidiolic acid)

Analysis according to EP monograph “Herbal drugs”

  • Pesticides (2.8.13)
  • Heavy metals Cd, Pb, Hg, if necessary As (2.4.27)
  • Aflatoxins B1, B2, G1and G2(2.8.18)
  • Ochratoxin A (2.8.22)
  • Microbiological quality (5.1.8 B)
  • TAMC, TYMC, Bile-tolerant gram-negative bacteria, coli, Salmonella

Terpene-Screening

Pyrrolizidine alkaloids

    Consulting Services

    Import license according to § 72 AMG

    • Support of procedure / application
    • Take on the duties and responsibilities of a qualified person according to § 14 (1) AMG
    • Draft contract according to § 9 AMWHV for quality control
    • Support of the inspection by the authorities
    • Implementation of CAPAs

      Narcotics license

      • Support of procedure / application
      • Take on the duties and responsibilities of a person responsible for narcotics according to § 3 BtMG

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