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Conforming with Therapeutic Goods (Standard for Medicinal Cannabis) (TGO 93) Order 2017

6 November 2020

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You must positively identify the cannabis plant used in the manufacture of medicinal cannabis products and differentiate it from potential adulterants and substitutes using each of the following identification methods (section 10 of TGO 93):

These identification methods must be suitably validated and performed on every batch of the cannabis plant.

TGA guidance Identification of herbal materials and extracts relates to the identification of plant materials, such as cannabis plant, that do not have a monograph in a pharmacopoeial standard. This guidance specifies that the macroscopic, microscopic, and chemical characteristics of the plant should be compared against either:

Further guidance on identification testing is given in United States Pharmacopeia-National Formulary General Chapter <563> Identification of articles of botanical origin.

Chromatographic procedures

Chromatographic procedures are chemical tests that determine whether the characteristic chemical constituents of the plant are present in the plant.

Examples of chromatographic procedures include:

  • high-performance liquid chromatography
  • thin-layer chromatography
  • gas chromatography

Tests may involve one or more chromatographic procedures. For example, the British Pharmacopoeia for Holy Basil Leaf (the dried leaves of Ocimum tenuiflorum) stipulates the use of macroscopic and microscopic examination as well as two thin-layer chromatography test procedures for the identification of the plant.

Chemical constituents of cannabis plant

Recognised chemical constituents of the cannabis plant include cannabinoids, such as tetrahydrocannabinols, and terpenes.

Examples of tetrahydrocannabinols include:

  • delta-9-tetrahydrocannabinol (also commonly referred to as tetrahydrocannabinol, delta-9 THC, or THC)
  • tetrahydrocannabinolic acid (THC-acid)
  • delta-8-THC
  • tetrahydrocannabivarin (THCV or THV)
  • 11-hydroxy-delta-9-THC

Examples of other cannabinoids include:

  • cannabidiol (CBD)
  • cannabidiolic acid (CBD-acid)
  • cannabichromene (CBC)
  • cannabinol (CBN)

Examples of terpenes include:

  • beta-caryophyllene
  • geraniol
  • alpha-humulene
  • limonene
  • linalool
  • myrcene

Some cannabinoids such as THC and CBD are unique to the Cannabis genus.

Gas chromatography can be used to confirm that cannabinoids and other characteristic terpenes are present in the cannabis plant.

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