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Food and Drug Regulations

Version of section C.04.601 from 2018-04-04 to 2023-01-25:

  •  (1) A fabricator shall not sell Sulphated Insulin unless he

    • (a) has filed with the Minister, in accordance with subsection (2), a submission relating to that preparation, in a form and having a content satisfactory to the Minister;

    • (b) has furnished the Minister with such additional information as the Minister may require; and

    • (c) has received from the Minister a notice that the information contained in the submission is in accordance with the requirements of this section.

  • (2) A submission filed pursuant to subsection (1) shall include at least,

    • (a) for each master lot of zinc-insulin crystals employed in the manufacture of Sulphated Insulin,

      • (i) protocols of assay of its potency in International Units per milligram,

      • (ii) a report of its moisture content in percentage determined by drying to constant weight at 100°C, and

      • (iii) reports of assay of its nitrogen content in milligrams and its zinc content in milligrams per 1,000 International Units of insulin; and

    • (b) for each lot of Sulphated Insulin prepared from each master lot of zinc-insulin crystals,

      • (i) a report of the amount of each component,

      • (ii) a report of the protein content in milligrams per 1,000 International Units of insulin,

      • (iii) a report on the determination of the neutralization ratio,

      • (iv) a report on the determination of the number of sulphate groups per insulin molecule,

      • (v) protocols of assay of its potency expressed as International Units per cubic centimetre, and

      • (vi) a report on the determination of its pH.

      • (vii) [Repealed, SOR/95-203, s. 9]

  • SOR/82-769, s. 4
  • SOR/95-203, s. 9
  • SOR/97-12, s. 61
  • SOR/2018-69, ss. 27, 31(E), 32(F)
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