Document ID: chunk:federal_register_of_legislation:F2024L01036:schedule:2
Version: federal_register_of_legislation:F2024L01036
Segment Type: schedule
Provision Reference: sch 2
Character Range: 10221–11851

Schedule 2—Specified tests for MDMA hydrochloride products
Note: See section 13.

  Specified tests
Column 1             Column 2                                        Column 3                       Column 4
Item               Test                                            Test method                    Requirement
  1                test for average content of MDMA hydrochloride    Ph Eur 2.2.29                not less than 90.0% and not more than 110.0% of the stated content in a pooled sample of not less than 20 capsules
  2                test for disintegration                           either:                      complete disintegration of the capsule must occur in a period of not more than 30 minutes
                                                                      (a) Ph Eur 2.9.1; or
                                                                      (b) USP Chapter 701
  3                test for related substances                     Ph Eur 2.2.29                  not more than the limits specified in Ph Eur 5.10
  4                test for residual solvents                      Ph Eur 2.4.24                  not more than the limits specified in Ph Eur 5.4
  5                test for uniformity of dosage units             either:                        not more than the limits specified in Ph Eur 2.9.40
                                                                      (a) mass variation; or
                                                                      (b) content uniformity;
                                                                   as specified in Ph Eur 2.9.40