Document ID: chunk:federal_register_of_legislation:F2024L01036:schedule:1
Version: federal_register_of_legislation:F2024L01036
Segment Type: schedule
Provision Reference: sch 1
Character Range: 9234–10129

Schedule 1—Specified tests for MDMA hydrochloride
Note: See section 9.

  Specified tests
Column 1             Column 2                            Column 3       Column 4
Item               Test                                Test method    Requirement
  1                test for heavy metals               Ph Eur 2.4.20  not more than the limits specified in the ICH Q3D guideline document
  2                test for purity of chloride         Ph Eur 2.2.29  not less than 15.3% and not more than 15.9%
  3                test for purity MDMA hydrochloride  Ph Eur 2.2.29  not less than 98.0% and not more than 102.0%, calculated on an anhydrous basis
  4                test for related substances         Ph Eur 2.2.29  not more than the limits specified in Ph Eur 5.10
  5                test for residual solvents          Ph Eur 2.4.24  not more than the limits specified in Ph Eur 5.4