{
  "url": "https://openlegislation.uk/good-laboratory-practice-regulations-1999/schedule-1/part-VI/paragraph-2",
  "json_url": "https://openlegislation.uk/good-laboratory-practice-regulations-1999/schedule-1/part-VI/paragraph-2.json",
  "legislation": "uksi/1999/3106",
  "legislation_title": "The Good Laboratory Practice Regulations 1999",
  "legislation_url": "https://openlegislation.uk/good-laboratory-practice-regulations-1999",
  "path": "schedule/1/part/VI/paragraph/2",
  "kind": "paragraph",
  "number": "2",
  "heading": "Characterisation",
  "text": "(1) Each test and reference item should be appropriately identified (eg code, chemical abstracts service registry number (CAS number), name, biological parameters etc.).\n(2) For each regulatory study, the identity, including batch number, purity, composition, concentrations, or other characteristics to appropriately define each batch of the test or reference items should be known.\n(3) In cases where the test item is supplied by the sponsor, there should be a mechanism, developed in co-operation between the sponsor and the test facility, to verify the identity of the test item subject to the study.\n(4) The stability of test and reference items under storage and test conditions should be known for all regulatory studies.\n(5) If the test item is administered or applied in a vehicle, the homogeneity, concentration and stability of the test item in that vehicle should be determined. For test items used in field studies (eg tank mixes), these may be determined through separate laboratory experiments.\n(6) A sample for analytical purposes from each batch of test item should be retained for all regulatory studies except short-term studies.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/1999/3106/schedule/1/part/VI/paragraph/2",
    "retrieved_at": "2026-10-29T09:35:14.315502+00:00"
  },
  "licence": "Open Government Licence v3.0",
  "licence_url": "https://www.nationalarchives.gov.uk/doc/open-government-licence/version/3/",
  "attribution": "Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives."
}